Trial Outcomes & Findings for Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections (NCT NCT01844856)
NCT ID: NCT01844856
Last Updated: 2022-01-11
Results Overview
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.
COMPLETED
PHASE3
541 participants
TOC visit: 25-31 days after the first dose of study drug
2022-01-11
Participant Flow
Participant milestones
| Measure |
Eravacycline, 1.0 mg/kg q12h
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, 1.0 g q24h
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.
|
|---|---|---|
|
Overall Study
STARTED
|
270
|
271
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
270
|
268
|
|
Overall Study
COMPLETED
|
246
|
255
|
|
Overall Study
NOT COMPLETED
|
24
|
16
|
Reasons for withdrawal
| Measure |
Eravacycline, 1.0 mg/kg q12h
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, 1.0 g q24h
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
3
|
|
Overall Study
Adverse Event
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Noncompliance
|
2
|
3
|
|
Overall Study
Enterococcus Resistant
|
0
|
1
|
|
Overall Study
Inadvertently Not Scheduled
|
1
|
0
|
|
Overall Study
Randomized but was a Screen Failure
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
Baseline characteristics by cohort
| Measure |
Eravacycline, 1.0 mg/kg q12h
n=270 Participants
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, 1.0 g q24h
n=271 Participants
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
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 16.92 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 16.09 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 16.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
261 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
523 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
263 participants
n=5 Participants
|
260 participants
n=7 Participants
|
523 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
38 participants
n=5 Participants
|
38 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
45 participants
n=5 Participants
|
44 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TOC visit: 25-31 days after the first dose of study drugPopulation: 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).
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.
Outcome measures
| Measure |
Eravacycline, 1.0 mg/kg q12h
n=220 Participants
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, 1.0 g q24h
n=226 Participants
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
|
|---|---|---|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population
Failure
|
19 participants
|
11 participants
|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population
Indeterminate
|
10 participants
|
17 participants
|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population
Cure
|
191 participants
|
198 participants
|
SECONDARY outcome
Timeframe: TOC visit: 25-31 days after first dosePopulation: All randomized participants who received at least 1 dose of study drug (MITT population).
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.
Outcome measures
| Measure |
Eravacycline, 1.0 mg/kg q12h
n=270 Participants
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, 1.0 g q24h
n=268 Participants
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
|
|---|---|---|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit
Cure
|
235 participants
|
238 participants
|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit
Failure
|
19 participants
|
15 participants
|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit
Indeterminate
|
16 participants
|
15 participants
|
SECONDARY outcome
Timeframe: TOC visit: 25-31 days after first dosePopulation: All randomized participants who had no major protocol deviations (CE population).
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.
Outcome measures
| Measure |
Eravacycline, 1.0 mg/kg q12h
n=239 Participants
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, 1.0 g q24h
n=238 Participants
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
|
|---|---|---|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit
Cure
|
222 participants
|
225 participants
|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit
Failure
|
17 participants
|
13 participants
|
|
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit
Indeterminate
|
0 participants
|
0 participants
|
Adverse Events
Eravacycline, 1.0 mg/kg q12h
Ertapenem, 1.0 g q24h
Serious adverse events
| Measure |
Eravacycline, 1.0 mg/kg q12h
n=270 participants at risk
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, 1.0 g q24h
n=268 participants at risk
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/270
|
0.37%
1/268
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/270
|
0.37%
1/268
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/270
|
0.37%
1/268
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/270
|
0.37%
1/268
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
0.00%
0/270
|
0.37%
1/268
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/270
|
0.37%
1/268
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.37%
1/270
|
0.00%
0/268
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.37%
1/270
|
0.37%
1/268
|
|
Gastrointestinal disorders
Ileus
|
0.37%
1/270
|
0.00%
0/268
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.37%
1/270
|
0.00%
0/268
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.37%
1/270
|
0.00%
0/268
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.37%
1/270
|
0.00%
0/268
|
|
General disorders
Multi-organ failure
|
0.37%
1/270
|
0.00%
0/268
|
|
Infections and infestations
Abdominal abscess
|
0.37%
1/270
|
0.75%
2/268
|
|
Infections and infestations
Empyema
|
0.37%
1/270
|
0.00%
0/268
|
|
Infections and infestations
Haematoma infection
|
0.37%
1/270
|
0.00%
0/268
|
|
Infections and infestations
Liver abscess
|
0.37%
1/270
|
0.37%
1/268
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/270
|
0.37%
1/268
|
|
Infections and infestations
Peritonitis
|
0.37%
1/270
|
0.00%
0/268
|
|
Infections and infestations
Pneumonia
|
0.74%
2/270
|
0.37%
1/268
|
|
Infections and infestations
Sepsis
|
0.00%
0/270
|
0.37%
1/268
|
|
Infections and infestations
Septic shock
|
0.00%
0/270
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.37%
1/270
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/270
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.37%
1/270
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.74%
2/270
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.37%
1/270
|
0.00%
0/268
|
|
Nervous system disorders
Cerebrovascular accident
|
0.37%
1/270
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/270
|
0.37%
1/268
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.37%
1/270
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
1/270
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/270
|
0.37%
1/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/270
|
0.75%
2/268
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/270
|
0.37%
1/268
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/270
|
0.37%
1/268
|
|
Surgical and medical procedures
Biliary drainage
|
0.37%
1/270
|
0.00%
0/268
|
|
Vascular disorders
Deep vein thrombosis
|
0.37%
1/270
|
0.00%
0/268
|
Other adverse events
| Measure |
Eravacycline, 1.0 mg/kg q12h
n=270 participants at risk
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, 1.0 g q24h
n=268 participants at risk
Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.1%
22/270
|
0.75%
2/268
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
11/270
|
3.4%
9/268
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
7/270
|
3.4%
9/268
|
|
General disorders
Pyrexia
|
2.2%
6/270
|
3.0%
8/268
|
|
Vascular disorders
Phlebitis
|
3.0%
8/270
|
0.37%
1/268
|
Additional Information
Chief Development Officer
La Jolla Pharmaceutical Company
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER