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   43873   clinical trials with a EudraCT protocol, of which   7292   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, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared with Ertapenem in Complicated Intra-abdominal Infections

    Summary
    EudraCT number
    		 2013-001913-34
    Trial protocol
    		 LV   CZ   EE   LT   DE   BG  
    Global end of trial date
    26 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2017
    First version publication date
    23 Aug 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TP-434-008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01844856
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tetraphase Pharmaceuticals, Inc.
    Sponsor organisation address
    480 Arsenal Street, Suite 110, Watertown, United States, 02472
    Public contact
    Chief Medical Officer, Tetraphase Pharmaceuticals, Inc., 1 617-715-3600,
    Scientific contact
    Chief Medical Officer, Tetraphase Pharmaceuticals, Inc., 1 617-715-3600,
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) E6 Good Clinical Practice (GCP) (consolidated guidelines pertaining to informed consent). At the first visit, prior to initiation of any study-related procedures, participants gave their written consent to participate in the study after having been informed about the nature and purpose of the study, participation/termination conditions, and risks and benefits; however, microbiologic specimens collected during routine operative care prior to participant consent may have been used for study purposes with the participant's knowledge and consent. Additionally, a Data Safety Monitoring Board was established to periodically review safety data (unblinded) from all participants and advise the Sponsor regarding the continuing safety of current participants and those yet to be recruited.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Aug 2013
    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
    Russian Federation: 52
    Country: Number of subjects enrolled
    Romania: 84
    Country: Number of subjects enrolled
    United States: 38
    Country: Number of subjects enrolled
    Ukraine: 76
    Country: Number of subjects enrolled
    Czech Republic: 31
    Country: Number of subjects enrolled
    Latvia: 48
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Bulgaria: 89
    Country: Number of subjects enrolled
    Lithuania: 52
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Estonia: 66
    Worldwide total number of subjects
    541
    EEA total number of subjects
    374
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    377
    From 65 to 84 years
    158
    85 years and over
    6

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants enrolled in this study were at least 18 years of age with a cIAI. Participants were eligible to participate in the study if they met all of the inclusion criteria and none of the exclusion criteria at the Screening visit.

    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
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eravacycline, 1.0 mg/kg q12h
    Arm description
    		 Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eravacycline
    Investigational medicinal product code
    TP-434
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.0 mg/kg q12h for 4-14 days

    Arm title
    		 Ertapenem, 1.0 g q24h
    Arm description
    		 Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ertapenem
    Investigational medicinal product code
    Other name
    Invanz
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.0 g q24h for 4-14 days

    Number of subjects in period 1
    		Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
    Started
    270
    271
    Received any amount of study drug
    270
    268
    Completed
    246
    255
    Not completed
    24
    16
         Consent withdrawn by subject
    3
    2
         Enterococcus Resistant
    -
    1
         Adverse event, non-fatal
    3
    6
         Randomized but was a Screen Failure
    -
    1
         Lost to follow-up
    15
    3
         Inadvertently Not Scheduled
    1
    -
         Noncompliance
    2
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Eravacycline, 1.0 mg/kg q12h
    Reporting group description
    		 Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.

    Reporting group title
    Ertapenem, 1.0 g q24h
    Reporting group description
    		 Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.

    Reporting group values
    		 Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h Total
    Number of subjects
    		 270 271 541
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 182 195 377
        From 65-84 years
    		 85 73 158
        85 years and over
    		 3 3 6
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.8 ( 16.92 ) 54.8 ( 16.09 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 114 108 222
        Male
    		 156 163 319
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 8 9 17
        Not Hispanic or Latino
    		 261 262 523
        Unknown or Not Reported
    		 1 0 1
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 263 260 523
        Black or African American
    		 1 3 4
        Asian
    		 1 3 4
        Other Race
    		 4 5 9
        Unknown or Not Reported
    		 1 0 1
    Region of Enrollment
    Units: Subjects
        Russian Federation
    		 28 24 52
        Romania
    		 42 42 84
        United States
    		 18 20 38
        Ukraine
    		 38 38 76
        Czech Republic
    		 14 17 31
        Latvia
    		 25 23 48
        South Africa
    		 0 1 1
        Bulgaria
    		 45 44 89
        Lithuania
    		 26 26 52
        Germany
    		 2 2 4
        Estonia
    		 32 34 66

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Eravacycline, 1.0 mg/kg q12h
    Reporting group description
    		 Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.

    Reporting group title
    Ertapenem, 1.0 g q24h
    Reporting group description
    		 Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.

    Subject analysis set title
    Eravacycline, 1.0 mg/kg q12h - micro-ITT Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had baseline bacterial pathogens that cause cIAI and against at least one of which the investigational drug has in vitro antibacterial activity (microbiological Intent-to-Treat [micro-ITT] Population).

    Subject analysis set title
    Ertapenem, 1.0 g q24h - micro-ITT Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had baseline bacterial pathogens that cause cIAI and against at least one of which the investigational drug has in vitro antibacterial activity (micro-ITT Population).

    Subject analysis set title
    Eravacycline, 1.0 mg/kg q12h - MITT Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized participants who received any amount of study drug (Modified Intent-to-Treat [MITT] Population).

    Subject analysis set title
    Ertapenem, 1.0 g q24h - MITT Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized participants who received any amount of study drug (MITT Population).

    Subject analysis set title
    Eravacycline, 1.0 mg/kg q12h - CE Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had no major protocol deviations (Clinically Evaluable [CE] Population).

    Subject analysis set title
    Ertapenem, 1.0 g q24h - CE Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had no major protocol deviations (CE Population).

    Primary: Clinical Response Of Eravacycline And Ertapenem Treatment Arms At The Test-Of-Cure (TOC) Visit In The MITT Population

    		 Close Top of page
    End point title
    		 Clinical Response Of Eravacycline And Ertapenem Treatment Arms At The Test-Of-Cure (TOC) Visit In The MITT Population
    End point description
    This was the co-primary outcome measure for the European Medicines Agency (EMA). Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to cIAI, unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
    End point type
    Primary
    End point timeframe
    TOC visit: 25-31 days after the first dose of study drug
    End point values
    		 Eravacycline, 1.0 mg/kg q12h - MITT Population Ertapenem, 1.0 g q24h - MITT Population
    Number of subjects analysed
    270 [1]
    268 [2]
    Units: participants
    number (not applicable)
        Cure
    235
    238
        Failure
    19
    15
        Indeterminate
    16
    15
    Notes
    [1] - All randomized participants who received any amount of study drug.
    [2] - All randomized participants who received any amount of study drug.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    A 2-sided 99% confidence interval (CI) for the observed difference in primary outcome rates (eravacycline treatment group minus ertapenem treatment group) was calculated. If the lower limit of the 99% CI for the difference in clinical cure rates exceeded −12.5%, then the null hypothesis was rejected, and the non-inferiority of eravacycline to ertapenem was declared.
    Comparison groups
    Eravacycline, 1.0 mg/kg q12h - MITT Population v Ertapenem, 1.0 g q24h - MITT Population
    Number of subjects included in analysis
    538
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.8
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 5.6

    Primary: Clinical Response Of Eravacycline And Ertapenem Treatment Arms In The CE Population At The TOC Visit

    		 Close Top of page
    End point title
    		 Clinical Response Of Eravacycline And Ertapenem Treatment Arms In The CE Population At The TOC Visit
    End point description
    This was the co-primary outcome measure for the EMA. Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to cIAI, unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
    End point type
    Primary
    End point timeframe
    TOC visit: 25-31 days after first dose
    End point values
    		 Eravacycline, 1.0 mg/kg q12h - CE Population Ertapenem, 1.0 g q24h - CE Population
    Number of subjects analysed
    239 [3]
    238 [4]
    Units: participants
    number (not applicable)
        Cure
    222
    225
        Failure
    17
    13
        Indeterminate
    0
    0
    Notes
    [3] - All randomized participants who had no major protocol deviations.
    [4] - All randomized participants who had no major protocol deviations.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    A 2-sided 99% CI for the observed difference in primary outcome rates (eravacycline treatment group minus ertapenem treatment group) was calculated. If the lower limit of the 99% CI for the difference in clinical cure rates exceeded −12.5%, then the null hypothesis was rejected, and the non-inferiority of eravacycline to ertapenem was declared.
    Comparison groups
    Eravacycline, 1.0 mg/kg q12h - CE Population v Ertapenem, 1.0 g q24h - CE Population
    Number of subjects included in analysis
    477
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 4.4

    Secondary: Clinical Response Of Eravacycline And Ertapenem Treatment Arms In The Micro-ITT Population At The TOC Visit

    		 Close Top of page
    End point title
    		 Clinical Response Of Eravacycline And Ertapenem Treatment Arms In The Micro-ITT Population At The TOC Visit
    End point description
    This was an outcome measure for the Food and Drug Administration (FDA). Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to cIAI, unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
    End point type
    Secondary
    End point timeframe
    TOC visit: 25-31 days after first dose
    End point values
    		 Eravacycline, 1.0 mg/kg q12h - micro-ITT Population Ertapenem, 1.0 g q24h - micro-ITT Population
    Number of subjects analysed
    220 [5]
    226 [6]
    Units: participants
    number (not applicable)
        Cure
    191
    198
        Failure
    19
    11
        Indeterminate
    10
    17
    Notes
    [5] - Randomized participants who had baseline bacterial pathogens and in vitro antibacterial activity.
    [6] - Randomized participants who had baseline bacterial pathogens and in vitro antibacterial activity.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded for all participants from the start of study drug administration through the follow-up visit, which occurred 38 to 50 days after the first dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Eravacycline, 1.0 mg/kg q12h
    Reporting group description
    		 Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.

    Reporting group title
    Ertapenem, 1.0 g q24h
    Reporting group description
    		 Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.

    Serious adverse events
    		 Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 270 (6.30%)
    16 / 268 (5.97%)
         number of deaths (all causes)
    3
    6
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    2 / 270 (0.74%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Surgical and medical procedures
    Biliary drainage
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    multi-organ failure
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal compartment syndrome
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 270 (0.37%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic fistula
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal fistula
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 270 (0.00%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary artery thrombosis
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Empyema
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    1 / 270 (0.37%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 270 (0.37%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 270 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 270 (0.74%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 270 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 270 (15.93%)
    28 / 268 (10.45%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    8 / 270 (2.96%)
    1 / 268 (0.37%)
         occurrences all number
    18
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 270 (2.59%)
    9 / 268 (3.36%)
         occurrences all number
    8
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 270 (2.22%)
    8 / 268 (2.99%)
         occurrences all number
    6
    8
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    22 / 270 (8.15%)
    2 / 268 (0.75%)
         occurrences all number
    24
    2
    Vomiting
         subjects affected / exposed
    11 / 270 (4.07%)
    9 / 268 (3.36%)
         occurrences all number
    11
    9

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jun 2013
    Amendment number 1 was implemented before any participants were enrolled and documented the following: the increase in the study sample size, inclusion of the micro-ITT population, change in assessment timing, change in microbiological specimen collection, clarification of inclusion and exclusion criteria, refinement of clinical response assessment, and other global administrative changes and clarifications.
    31 Oct 2013
    Amendment number 2 was implemented after 197 participants were enrolled and documented the following: the change in primary analysis populations and non-inferiority margin for the EMA, revision of the inclusion and exclusion criteria, change in the dose of eravacycline was limited to 1.0 mg/kg, up to a maximum of 150 mg q12h, changes in the restricted concomitant medications, clarification on study drug and placebo preparation, change in the maximum dosage in 24 hours, and other global administrative changes and clarifications. Changes to the protocol were considered to have no negative impact on the safety of participants already enrolled into the study.

    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-Mon May 06 17:44:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA