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Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections (IGNITE1)

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ClinicalTrials.gov Identifier: NCT01844856
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Tetraphase Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Complicated Intra-abdominal Infections
Interventions Drug: Eravacycline
Drug: Ertapenem
Drug: Placebo
Enrollment 541
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Hide Arm/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. Ertapenem was administered IV at a dose of 1.0 grams (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.
Period Title: Overall Study
Started 270 271
Received at Least 1 Dose of Study Drug 270 268
Completed 246 255
Not Completed 24 16
Reason Not Completed
Lost to Follow-up             15             3
Adverse Event             3             6
Withdrawal by Subject             3             2
Noncompliance             2             3
Enterococcus Resistant             0             1
Inadvertently Not Scheduled             1             0
Randomized but was a Screen Failure             0             1
Arm/Group Title Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h Total
Hide Arm/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. Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days. Total of all reporting groups
Overall Number of Baseline Participants 270 271 541
Hide Baseline Analysis Population Description
All randomized participants (Intent-to-treat [ITT] population)
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 270 participants 271 participants 541 participants
54.8  (16.92) 54.8  (16.09) 54.8  (16.49)
[1]
Measure Description: Mean/standard deviation of age for the combined eravacycline and ertapenem treatment groups was calculated by hand.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 271 participants 541 participants
Female
114
  42.2%
108
  39.9%
222
  41.0%
Male
156
  57.8%
163
  60.1%
319
  59.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 271 participants 541 participants
Hispanic or Latino
8
   3.0%
9
   3.3%
17
   3.1%
Not Hispanic or Latino
261
  96.7%
262
  96.7%
523
  96.7%
Unknown or Not Reported
1
   0.4%
0
   0.0%
1
   0.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 270 participants 271 participants 541 participants
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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 270 participants 271 participants 541 participants
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
1.Primary Outcome
Title Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population
Hide Description Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [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.
Time Frame TOC visit: 25-31 days after the first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population 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).
Arm/Group Title Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Hide Arm/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.
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
Overall Number of Participants Analyzed 220 226
Measure Type: Number
Unit of Measure: participants
Cure 191 198
Failure 19 11
Indeterminate 10 17
2.Secondary Outcome
Title Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit
Hide Description Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [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.
Time Frame TOC visit: 25-31 days after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug (MITT population).
Arm/Group Title Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Hide Arm/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.
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
Overall Number of Participants Analyzed 270 268
Measure Type: Number
Unit of Measure: participants
Cure 235 238
Failure 19 15
Indeterminate 16 15
3.Secondary Outcome
Title Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit
Hide Description Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [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.
Time Frame TOC visit: 25-31 days after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had no major protocol deviations (CE population).
Arm/Group Title Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Hide Arm/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.
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
Overall Number of Participants Analyzed 239 238
Measure Type: Number
Unit of Measure: participants
Cure 222 225
Failure 17 13
Indeterminate 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Hide Arm/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. Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
All-Cause Mortality
Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Affected / at Risk (%) Affected / at Risk (%)
Total   17/270 (6.30%)   16/268 (5.97%) 
Cardiac disorders     
Atrial fibrillation  1  0/270 (0.00%)  1/268 (0.37%) 
Cardiopulmonary failure  1  0/270 (0.00%)  1/268 (0.37%) 
Pulseless electrical activity  1  0/270 (0.00%)  1/268 (0.37%) 
Supraventricular tachycardia  1  0/270 (0.00%)  1/268 (0.37%) 
Gastrointestinal disorders     
Abdominal compartment syndrome  1  0/270 (0.00%)  1/268 (0.37%) 
Colonic fistula  1  0/270 (0.00%)  1/268 (0.37%) 
Diverticular perforation  1  1/270 (0.37%)  0/268 (0.00%) 
Duodenal ulcer haemorrhage  1  1/270 (0.37%)  1/268 (0.37%) 
Ileus  1  1/270 (0.37%)  0/268 (0.00%) 
Intestinal fistula  1  1/270 (0.37%)  0/268 (0.00%) 
Oesophageal fistula  1  1/270 (0.37%)  0/268 (0.00%) 
Pancreatitis necrotising  1  1/270 (0.37%)  0/268 (0.00%) 
General disorders     
Multi-organ failure  1  1/270 (0.37%)  0/268 (0.00%) 
Infections and infestations     
Abdominal abscess  1  1/270 (0.37%)  2/268 (0.75%) 
Empyema  1  1/270 (0.37%)  0/268 (0.00%) 
Haematoma infection  1  1/270 (0.37%)  0/268 (0.00%) 
Liver abscess  1  1/270 (0.37%)  1/268 (0.37%) 
Peritoneal abscess  1  0/270 (0.00%)  1/268 (0.37%) 
Peritonitis  1  1/270 (0.37%)  0/268 (0.00%) 
Pneumonia  1  2/270 (0.74%)  1/268 (0.37%) 
Sepsis  1  0/270 (0.00%)  1/268 (0.37%) 
Septic shock  1  0/270 (0.00%)  1/268 (0.37%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence  1  1/270 (0.37%)  0/268 (0.00%) 
Gastrointestinal stoma complication  1  0/270 (0.00%)  1/268 (0.37%) 
Splenic rupture  1  1/270 (0.37%)  0/268 (0.00%) 
Wound dehiscence  1  2/270 (0.74%)  1/268 (0.37%) 
Wound evisceration  1  1/270 (0.37%)  0/268 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/270 (0.37%)  0/268 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/270 (0.00%)  1/268 (0.37%) 
Acute respiratory failure  1  1/270 (0.37%)  0/268 (0.00%) 
Pleural effusion  1  1/270 (0.37%)  0/268 (0.00%) 
Pulmonary artery thrombosis  1  0/270 (0.00%)  1/268 (0.37%) 
Pulmonary embolism  1  0/270 (0.00%)  2/268 (0.75%) 
Respiratory disorder  1  0/270 (0.00%)  1/268 (0.37%) 
Respiratory failure  1  0/270 (0.00%)  1/268 (0.37%) 
Surgical and medical procedures     
Biliary drainage  1  1/270 (0.37%)  0/268 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/270 (0.37%)  0/268 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Eravacycline, 1.0 mg/kg q12h Ertapenem, 1.0 g q24h
Affected / at Risk (%) Affected / at Risk (%)
Total   43/270 (15.93%)   28/268 (10.45%) 
Blood and lymphatic system disorders     
Anaemia  1  7/270 (2.59%)  9/268 (3.36%) 
Gastrointestinal disorders     
Nausea  1  22/270 (8.15%)  2/268 (0.75%) 
Vomiting  1  11/270 (4.07%)  9/268 (3.36%) 
General disorders     
Pyrexia  1  6/270 (2.22%)  8/268 (2.99%) 
Vascular disorders     
Phlebitis  1  8/270 (2.96%)  1/268 (0.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At least 60 days prior to submitting or presenting a manuscript, poster, presentation, abstract or other materials relating to the Trial, the PI shall provide to Sponsor all such manuscripts and materials, and Sponsor shall have 60 days to review and comment. If requested, the PI shall remove confidential information prior to submitting or presenting the materials, and shall delay publication or presentation for up to 90 days to allow Sponsor to protect its interests in any such materials.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Tetraphase Pharmaceuticals, Inc.
Phone: +1.617.715.3600
Layout table for additonal information
Responsible Party: Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01844856    
Other Study ID Numbers: TP-434-008
First Submitted: April 29, 2013
First Posted: May 1, 2013
Results First Submitted: January 26, 2016
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016