Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3 Randomized, Active-comparator-controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Subjects from Birth to less than 12 Years of Age with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

    Summary
    EudraCT number
    		 2016-003884-20
    Trial protocol
    		 Outside EU/EEA   DE   PL   BG   LT   LV  
    Global end of trial date
    13 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2024
    First version publication date
    13 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-1986-018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03176134
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001379-PIP01-12
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 42
    Country: Number of subjects enrolled
    Georgia: 11
    Country: Number of subjects enrolled
    Guatemala: 12
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    Mexico: 3
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    South Africa: 11
    Country: Number of subjects enrolled
    Türkiye: 1
    Country: Number of subjects enrolled
    Ukraine: 14
    Worldwide total number of subjects
    100
    EEA total number of subjects
    45
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    20
    Children (2-11 years)
    80
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at 20 centers in 14 countries. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to <28 Days Neonates) and Cohort 4: Comparator (Birth to <28 Days Term & preterm neonates).

    Pre-assignment
    Screening details
    		 101 participants were screened and 100 received treatment. Subjects were randomized in a 3:1 ratio to tedizolid phosphate (intravenous [IV] and/or oral suspension) or comparator (IV and/or oral dosage form). Subjects are stratified by age group, with dose level determined by weight.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years
    Arm description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid Phosphate IV solution or oral suspension
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA
    Pharmaceutical forms
    Powder for oral suspension, Powder for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Once-daily, single 200-mg dose (subjects with body weight ≥50 kg), for 6 to 10 days OR twice-daily (q12h) 2 mg /kg doses (subjects with body weight ≥30 to <50 kg), for 6 to 10 days OR twice-daily (q12h) 2.5 mg /kg doses (subjects with body weight 3.2 to <30 kg), for 6 to 10 days.

    Arm title
    		 Cohort 1: Comparator 6 to <12 Years
    Arm description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension, Powder for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Vancomycin: 10 mg/kg with goal trough level of 10 to 15 mcg/mL every 6 to 8 hours, for 10 to 14 days OR Cephazolin (Cefazolin): 50 or 100 mg/kg/day (up to 1,000 mg/dose) OR Linezolid: 10 mg/kg/dose (up to maximum dose 600 mg) OR Clindamycin: IV: 30 mg/kg/day (up to 600 mg/dose), Oral: 30 mg/kg/day (up to 450 mg/dose) OR Flucloxacillin: IV: 125 to 250 mg (2 to 10 years) or 62.5 to 125 mg (<2 years), Oral: 125 mg (2 to 10 years) or 62.5 mg (<2 years) OR Cephalexin (Cefalexin): 25 to 50 mg/kg/day (up to 500 mg/dose).

    Arm title
    		 Cohort 2: Tedizolid phosphate 2 to <6 Years
    Arm description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate IV solution or oral suspension
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA
    Pharmaceutical forms
    Powder for oral suspension, Powder for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Once-daily, single 200-mg dose (subjects with body weight ≥50 kg), for 6 to 10 days OR twice-daily (q12h) 2 mg /kg doses (subjects with body weight ≥30 to <50 kg), for 6 to 10 days OR twice-daily (q12h) 2.5 mg /kg doses (subjects with body weight 3.2 to <30 kg), for 6 to 10 days.

    Arm title
    		 Cohort 2: Comparator 2 to <6 Years
    Arm description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension, Powder for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Vancomycin: 10 mg/kg with goal trough level of 10 to 15 mcg/mL every 6 to 8 hours, for 10 to 14 days OR Cephazolin (Cefazolin): 50 or 100 mg/kg/day (up to 1,000 mg/dose) OR Linezolid: 10 mg/kg/dose (up to maximum dose 600 mg) OR Clindamycin: IV: 30 mg/kg/day (up to 600 mg/dose), Oral: 30 mg/kg/day (up to 450 mg/dose) OR Flucloxacillin: IV: 125 to 250 mg (2 to 10 years) or 62.5 to 125 mg (<2 years), Oral: 125 mg (2 to 10 years) or 62.5 mg (<2 years) OR Cephalexin (Cefalexin): 25 to 50 mg/kg/day (up to 500 mg/dose).

    Arm title
    		 Cohort 3: Tedizolid phosphate 28 Days to <2 Years
    Arm description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate IV solution or oral suspension
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA
    Pharmaceutical forms
    Powder for oral suspension, Powder for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Once-daily, single 200-mg dose (subjects with body weight ≥50 kg), for 6 to 10 days OR twice-daily (q12h) 2 mg /kg doses (subjects with body weight ≥30 to <50 kg), for 6 to 10 days OR twice-daily (q12h) 2.5 mg /kg doses (subjects with body weight 3.2 to <30 kg), for 6 to 10 days.

    Arm title
    		 Cohort 3: Comparator 28 Days to <2 Years
    Arm description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension, Powder for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Vancomycin: 10 mg/kg with goal trough level of 10 to 15 mcg/mL every 6 to 8 hours, for 10 to 14 days OR Cephazolin (Cefazolin): 50 or 100 mg/kg/day (up to 1,000 mg/dose) OR Linezolid: 10 mg/kg/dose (up to maximum dose 600 mg) OR Clindamycin: IV: 30 mg/kg/day (up to 600 mg/dose), Oral: 30 mg/kg/day (up to 450 mg/dose) OR Flucloxacillin: IV: 125 to 250 mg (2 to 10 years) or 62.5 to 125 mg (<2 years), Oral: 125 mg (2 to 10 years) or 62.5 mg (<2 years) OR Cephalexin (Cefalexin): 25 to 50 mg/kg/day (up to 500 mg/dose).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Per protocol, the only role blinded in this study was the assessor.
    Number of subjects in period 1
    		Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years
    Started
    44
    15
    16
    5
    15
    5
    Completed
    42
    13
    14
    5
    15
    5
    Not completed
    2
    2
    2
    0
    0
    0
         Withdrawal by Parent/Guardian
    2
    -
    2
    -
    -
    -
         Lost to follow-up
    -
    2
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Tedizolid phosphate 6 to <12 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 1: Comparator 6 to <12 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Reporting group title
    Cohort 2: Tedizolid phosphate 2 to <6 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 2: Comparator 2 to <6 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Reporting group title
    Cohort 3: Tedizolid phosphate 28 Days to <2 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 3: Comparator 28 Days to <2 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Reporting group values
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years Total
    Number of subjects
    		 44 15 16 5 15 5 100
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 15 5 20
        Children (2-11 years)
    		 44 15 16 5 0 0 80
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.5 ± 1.7 9.2 ± 1.4 3.1 ± 1.1 3.4 ± 1.1 0.9 ± 0.2 1.0 ± 0.1 -
    Gender Categorical
    Units: Participants
        Female
    		 16 8 8 2 11 2 47
        Male
    		 28 7 8 3 4 3 53
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 1 0 1
        Black or African American
    		 0 0 1 0 9 1 11
        Multiple
    		 3 0 2 1 1 1 8
        White
    		 41 15 13 4 4 3 80
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 6 2 5 1 2 1 17
        Not Hispanic or Latino
    		 38 13 11 4 13 4 83

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cohort 1: Tedizolid phosphate 6 to <12 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 1: Comparator 6 to <12 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Reporting group title
    Cohort 2: Tedizolid phosphate 2 to <6 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 2: Comparator 2 to <6 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Reporting group title
    Cohort 3: Tedizolid phosphate 28 Days to <2 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 3: Comparator 28 Days to <2 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Primary: Number of participants with ≥1 adverse events (AEs)

    		 Close Top of page
    End point title
    		 Number of participants with ≥1 adverse events (AEs) [1]
    End point description
    An AE was any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants with one or more AEs were reported. All randomized participants who received at least 1 dose of study intervention according to the study intervention they received were assessed.
    End point type
    Primary
    End point timeframe
    Up to approximately day 35
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No between-arm statistical comparisons were planned for this endpoint.
    End point values
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years
    Number of subjects analysed
    44
    15
    16
    5
    15
    5
    Units: Number of participants
    7
    2
    7
    2
    7
    2
    No statistical analyses for this end point

    Primary: Number of participants discontinuing from study therapy due to AEs

    		 Close Top of page
    End point title
    		 Number of participants discontinuing from study therapy due to AEs [2]
    End point description
    An AE was any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants discontinued from the study due to an AE were reported. All randomized participants who received at least 1 dose of study intervention according to the study intervention they received were assessed.
    End point type
    Primary
    End point timeframe
    Up to approximately day 15
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No between-arm statistical comparisons were planned for this endpoint.
    End point values
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years
    Number of subjects analysed
    44
    15
    16
    5
    15
    5
    Units: Number of participants
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with hematopoietic cytopenias

    		 Close Top of page
    End point title
    		 Number of participants with hematopoietic cytopenias [3]
    End point description
    A standardized MedDRA query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported. All randomized participants who received at least 1 dose of study intervention according to the study intervention they received were assessed.
    End point type
    Primary
    End point timeframe
    Up to approximately day 35
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No between-arm statistical comparisons were planned for this endpoint.
    End point values
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years
    Number of subjects analysed
    44
    15
    16
    5
    15
    5
    Units: Number of participants
    0
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinical success

    		 Close Top of page
    End point title
    		 Number of participants with clinical success
    End point description
    The investigator's assessment of clinical response were conducted at the Test of Cure (TOC) visit, approximately 25 days after the first infusion. Clinical success was defined as 1) resolution or near-resolution of most signs and symptoms, 2) absence or near-resolution of signs of infection, and 3) no new signs, symptoms, or complications attributable to the infections (no further antibiotic therapy required for the primary lesion). The number of participants with clinical success were reported. All randomized participants were assessed.
    End point type
    Secondary
    End point timeframe
    Up to approximately day 25
    End point values
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years
    Number of subjects analysed
    44
    15
    16
    5
    15
    5
    Units: Number of participants
        Clinical success
    41
    13
    14
    5
    15
    5
        Clinical failure/indeterminate
    3
    2
    2
    0
    0
    0
    Statistical analysis title
    		 Estimated Difference (%)
    Statistical analysis description
    The estimated difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval were calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Cohort 1: Tedizolid phosphate 6 to <12 Years v Cohort 1: Comparator 6 to <12 Years
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated Difference (%)
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 25.3
    Statistical analysis title
    		 Estimated Difference (%)
    Statistical analysis description
    The estimated difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval were calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Cohort 2: Tedizolid phosphate 2 to <6 Years v Cohort 2: Comparator 2 to <6 Years
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated Difference (%)
    Point estimate
    -12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.7
         upper limit
    		 3.7
    Statistical analysis title
    		 Estimated Difference (%)
    Statistical analysis description
    The estimated difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval were calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Cohort 3: Tedizolid phosphate 28 Days to <2 Years v Cohort 3: Comparator 28 Days to <2 Years
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated Difference (%)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 35 days
    Adverse event reporting additional description
    All-cause mortality: all randomized participants who received at least one dose of study treatment; Safety: all randomized participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Cohort 1: Tedizolid phosphate 6 to <12 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 1: Comparator 6 to <12 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Reporting group title
    Cohort 2: Tedizolid phosphate 2 to <6 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 2: Comparator 2 to <6 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Reporting group title
    Cohort 3: Tedizolid phosphate 28 Days to <2 Years
    Reporting group description
    		 Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

    Reporting group title
    Cohort 3: Comparator 28 Days to <2 Years
    Reporting group description
    		 Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

    Serious adverse events
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 1: Comparator 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years Cohort 2: Comparator 2 to <6 Years Cohort 3: Tedizolid phosphate 28 Days to <2 Years Cohort 3: Comparator 28 Days to <2 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 15 (13.33%)
    7 / 16 (43.75%)
    2 / 5 (40.00%)
    7 / 15 (46.67%)
    2 / 5 (40.00%)
    Investigations
    White blood cell count increased
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Scratch
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Vascular disorders
    Pallor
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Neutropenia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 15 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    1
    0
    0
    1
    0
    3
    Constipation
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Miliaria
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Nightmare
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    3 / 15 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    2 / 15 (13.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    2
    2
    0
    Viral infection
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 15 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Viral diarrhoea
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 15 (6.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    1 / 15 (6.67%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2017
    AM1: Reduced minimum age to birth; clarification of minimum sample sizes in each age group.
    04 Jul 2018
    AM2: Dose adjustment, addition of excluded medications, modification of inclusion criteria (IC)/exclusion criteria (EC).
    19 Nov 2018
    AM3: Dose adjustment including modification to q12h dosing; modified extension of treatment to allow 1- 4 days of extension (not fixed at 4 days’ extension); added recommendations for comparator dosing; modification of IC/EC; modification of procedures e.g. pharmacokinetic (PK) sampling to account for twice-daily dosing regimen.
    12 Nov 2019
    AM4: Dosing adjustment due to a preplanned analysis.
    21 Oct 2020
    AM5: Preplanned addition of dose levels for children 28 days to <2 years of age (Cohort 3) based on updated modeling and simulation using newly available data from ongoing studies; addition of country specific eligibility requirements; and addition of study termination criteria and data protection policies.
    19 Jul 2021
    AM6: Eliminated certain eligibility constraints and reduced the number of required in-person visits in order to improve feasibility to enroll outpatients.
    05 Aug 2022
    AM7: Added a potential interim analysis for the 2 Cohorts spanning 2 to <12 years of age in order to support a possible regulatory filing for this age group in light of the slower enrollment of children <2 years of age; reduced the sample size from 120 to 100; and revised eligibility criterion regarding allowed duration of prior antibiotic treatment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 08:30:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA