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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants Less Than 3 Months of Age

    Summary
    EudraCT number
    		 2013-002084-26
    Trial protocol
    		 BG   Outside EU/EEA  
    Global end of trial date
    28 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2018
    First version publication date
    15 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0991-064
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01945281
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    28 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study evaluated the safety, tolerability, and efficacy of caspofungin as compared with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants. The primary hypothesis to be tested in the study is that caspofungin was superior to amphotericin B deoxycholate with regard to the proportion of participants with fungal-free survival at the 2-week post-therapy follow-up visit.
    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
    15 Jan 2014
    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
    Brazil: 5
    Country: Number of subjects enrolled
    Colombia: 6
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    South Africa: 17
    Country: Number of subjects enrolled
    Turkey: 14
    Worldwide total number of subjects
    51
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    28
    Infants and toddlers (28 days-23 months)
    23
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants less than 3 months of age with invasive candidiasis were enrolled in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Caspofungin
    Arm description
    		 Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Caspofungin acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous once daily for ≥14 days

    Arm title
    		 Amphotericin B Deoxycholate
    Arm description
    		 Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amphotericin B Deoxycholate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous once daily for ≥14 days

    Number of subjects in period 1
    		Caspofungin Amphotericin B Deoxycholate
    Started
    34
    17
    Treated
    33
    16
    Completed
    28
    13
    Not completed
    6
    4
         Adverse event, serious fatal
    3
    3
         Physician decision
    1
    1
         Adverse event, non-fatal
    1
    -
         Technical Problems
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Caspofungin
    Reporting group description
    		 Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Reporting group title
    Amphotericin B Deoxycholate
    Reporting group description
    		 Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Reporting group values
    		 Caspofungin Amphotericin B Deoxycholate Total
    Number of subjects
    		 34 17 51
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 19 9 28
        Infants and toddlers (28 days-23 months)
    		 15 8 23
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    		 31.1 ( 20.9 ) 32.8 ( 23.3 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 14 10 24
        Male
    		 20 7 27
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 3 1 4
        Black or African American
    		 13 6 19
        White
    		 13 8 21
        More than one race
    		 5 2 7
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 12 7 19
        Not Hispanic or Latino
    		 19 9 28
        Unknown or Not Reported
    		 3 1 4
    Weight
    Weight at Baseline Measurement. The population analyzed was participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
    Units: Grams
        arithmetic mean (standard deviation)
    		 ( ) ( ) -
    Subject analysis sets

    Subject analysis set title
    Caspofungin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Subject analysis set title
    Amphotericin B Deoxycholate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Subject analysis sets values
    		 Caspofungin Amphotericin B Deoxycholate
    Number of subjects
    31
    16
    Age Categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender Categorical
    Units: Subjects
        Female
        Male
    Race
    Units: Subjects
        American Indian or Alaska Native
        Black or African American
        White
        More than one race
    Ethnicity
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
        Unknown or Not Reported
    Weight
    Weight at Baseline Measurement. The population analyzed was participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
    Units: Grams
        arithmetic mean (standard deviation)
    1982.1 ( 980.6 )
    2160.9 ( 1513.8 )

    End points

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    End points reporting groups
    Reporting group title
    Caspofungin
    Reporting group description
    		 Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Reporting group title
    Amphotericin B Deoxycholate
    Reporting group description
    		 Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Subject analysis set title
    Caspofungin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Subject analysis set title
    Amphotericin B Deoxycholate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Primary: Percentage of Participants with Fungal-free Survival Through the 2-week Post-therapy Period

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    End point title
    		 Percentage of Participants with Fungal-free Survival Through the 2-week Post-therapy Period
    End point description
    Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. The population analyzed was participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
    End point type
    Primary
    End point timeframe
    Up to 104 days
    End point values
    		 Caspofungin Amphotericin B Deoxycholate
    Number of subjects analysed
    31
    16
    Units: Percentage of Participants
        number (confidence interval 95%)
    71.0 (52.0 to 85.8)
    68.8 (41.3 to 89.0)
    Statistical analysis title
    		 Caspofungin minus Amphotericin
    Statistical analysis description
    Miettinen & Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel- Haenszel’s weights.
    Comparison groups
    Caspofungin v Amphotericin B Deoxycholate
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.3
         upper limit
    		 27.7

    Secondary: Percentage of Participants with Fungal-free Survival Through the End of Study Treatment

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    End point title
    		 Percentage of Participants with Fungal-free Survival Through the End of Study Treatment
    End point description
    Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. The population analyzed was participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
    End point type
    Secondary
    End point timeframe
    Up to 90 days
    End point values
    		 Caspofungin Amphotericin B Deoxycholate
    Number of subjects analysed
    31
    16
    Units: Percentage of Participants
        number (confidence interval 95%)
    71.0 (52.0 to 85.8)
    75.0 (47.6 to 92.7)
    Statistical analysis title
    		 Caspofungin minus Amphotericin
    Statistical analysis description
    Miettinen & Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel- Haenszel’s weights
    Comparison groups
    Caspofungin v Amphotericin B Deoxycholate
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.2
         upper limit
    		 22.6

    Secondary: Number of participants with an adverse event (AE)

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    End point title
    		 Number of participants with an adverse event (AE)
    End point description
    An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE. The population analyzed was all participants as treated.
    End point type
    Secondary
    End point timeframe
    8 weeks after end of study therapy (up to 146 days)
    End point values
    		 Caspofungin Amphotericin B Deoxycholate
    Number of subjects analysed
    33
    16
    Units: Participants
    28
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8 weeks after end of study therapy (up to 146 days)
    Adverse event reporting additional description
    All participants as treated
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Caspofungin
    Reporting group description
    		 Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Reporting group title
    Amphotericin B deoxycholate
    Reporting group description
    		 Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

    Serious adverse events
    		 Caspofungin Amphotericin B deoxycholate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 33 (21.21%)
    9 / 16 (56.25%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Anastomotic complication
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Suture rupture
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising colitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising enterocolitis neonatal
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia escherichia
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Caspofungin Amphotericin B deoxycholate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 33 (69.70%)
    15 / 16 (93.75%)
    General disorders and administration site conditions
    Hypothermia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    6 / 33 (18.18%)
    3 / 16 (18.75%)
         occurrences all number
    10
    6
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Apnoea
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Aspiration
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Respiratory acidosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Respiratory failure
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Blood bilirubin increased
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Blood bilirubin unconjugated increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Blood potassium increased
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    Tachycardia
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 16 (12.50%)
         occurrences all number
    2
    2
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 16 (6.25%)
         occurrences all number
    5
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 33 (30.30%)
    8 / 16 (50.00%)
         occurrences all number
    16
    12
    Leukostasis syndrome
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Eye disorders
    Eye discharge
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 16 (12.50%)
         occurrences all number
    2
    2
    Anal fissure
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Necrotising enterocolitis neonatal
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 16 (6.25%)
         occurrences all number
    4
    2
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Jaundice
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Skin ulcer
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Renal tubular necrosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Sepsis
         subjects affected / exposed
    3 / 33 (9.09%)
    5 / 16 (31.25%)
         occurrences all number
    5
    6
    Septic shock
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Feeding intolerance
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Hyperglycaemia
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Hypernatraemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypochloraemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 16 (12.50%)
         occurrences all number
    3
    5
    Hypokalaemia
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 16 (6.25%)
         occurrences all number
    3
    1
    Metabolic alkalosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2013
    Amendment 1: Revision of pharmacokinetic blood sampling schedule for study participants.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Feb 2018
    The trial was terminated early due to operational feasibility with low recruitment due to changing epidemiology of disease.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial was terminated early due to operational feasibility with low recruitment due to changing epidemiology of disease.
    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.

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