Trial Outcomes & Findings for Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections (NCT NCT01147640)
NCT ID: NCT01147640
Last Updated: 2018-10-25
Results Overview
Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Test-of-Cure Visit (7-14 days after End of Therapy [EOT])
Results posted on
2018-10-25
Participant Flow
Participant milestones
| Measure |
CXA 101/Tazobactam and Metronidazole
CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
|
Meropenem With Matching Saline Placebo
meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
39
|
|
Overall Study
COMPLETED
|
78
|
38
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
CXA 101/Tazobactam and Metronidazole
CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
|
Meropenem With Matching Saline Placebo
meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Didn't meet eligibility criteria
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections
Baseline characteristics by cohort
| Measure |
CXA 101/Tazobactam and Metronidazole
n=82 Participants
CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
|
Meropenem With Matching Saline Placebo
n=39 Participants
meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 18.79 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 18.48 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 18.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Test-of-Cure Visit (7-14 days after End of Therapy [EOT])Population: mMITT: Treated subjects, with baseline pathogen
Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
Outcome measures
| Measure |
CXA 101/Tazobactam and Metronidazole
n=61 Participants
CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
|
Meropenem With Matching Saline Placebo
n=25 Participants
meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
|
|---|---|---|
|
Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population
|
83.6 percentage of subjects
Interval 71.9 to 91.8
|
96.0 percentage of subjects
Interval 79.6 to 99.9
|
SECONDARY outcome
Timeframe: Test-of-Cure Visit (7-14 days after EOT)Population: Microbiologically Evaluable: treated subjects, with baseline pathogen susceptible to study drug, complied with protocol
Microbiological response is eradication (absence of the baseline pathogen from a suitable intra-abdominal specimen) or presumed eradication (absence of a suitable intra-abdominal specimen to culture at the TOC visit in a subject who is assessed as a clinical cure at TOC)
Outcome measures
| Measure |
CXA 101/Tazobactam and Metronidazole
n=53 Participants
CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
|
Meropenem With Matching Saline Placebo
n=24 Participants
meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
|
|---|---|---|
|
Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population
|
90.6 percentage of subjects
Interval 79.3 to 96.9
|
95.8 percentage of subjects
Interval 78.9 to 99.9
|
Adverse Events
CXA 101/Tazobactam and Metronidazole
Serious events: 14 serious events
Other events: 30 other events
Deaths: 0 deaths
Meropenem With Matching Saline Placebo
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CXA 101/Tazobactam and Metronidazole
n=82 participants at risk
CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
|
Meropenem With Matching Saline Placebo
n=39 participants at risk
meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/82
|
0.00%
0/39
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/82
|
0.00%
0/39
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.2%
1/82
|
0.00%
0/39
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.2%
1/82
|
0.00%
0/39
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/82
|
2.6%
1/39
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/82
|
2.6%
1/39
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/82
|
2.6%
1/39
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.2%
1/82
|
0.00%
0/39
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.2%
1/82
|
0.00%
0/39
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/82
|
0.00%
0/39
|
|
Infections and infestations
Peridiverticular abscess
|
1.2%
1/82
|
0.00%
0/39
|
|
Infections and infestations
Pneumonia
|
1.2%
1/82
|
0.00%
0/39
|
|
Infections and infestations
Postoperative wound infection
|
1.2%
1/82
|
0.00%
0/39
|
|
Infections and infestations
Urosepsis
|
1.2%
1/82
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Seroma
|
1.2%
1/82
|
0.00%
0/39
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/82
|
0.00%
0/39
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/82
|
0.00%
0/39
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
1.2%
1/82
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/82
|
0.00%
0/39
|
|
Vascular disorders
Haematoma
|
1.2%
1/82
|
0.00%
0/39
|
|
Vascular disorders
Shock
|
1.2%
1/82
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/82
|
2.6%
1/39
|
Other adverse events
| Measure |
CXA 101/Tazobactam and Metronidazole
n=82 participants at risk
CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
|
Meropenem With Matching Saline Placebo
n=39 participants at risk
meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.1%
5/82
|
10.3%
4/39
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
4/82
|
7.7%
3/39
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
4/82
|
7.7%
3/39
|
|
Gastrointestinal disorders
Ileus
|
3.7%
3/82
|
0.00%
0/39
|
|
General disorders
Pyrexia
|
14.6%
12/82
|
10.3%
4/39
|
|
Vascular disorders
Hypertension
|
4.9%
4/82
|
5.1%
2/39
|
|
Vascular disorders
Phlebitis
|
2.4%
2/82
|
5.1%
2/39
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.7%
3/82
|
0.00%
0/39
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.7%
3/82
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.4%
2/82
|
5.1%
2/39
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
3.7%
3/82
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
5/82
|
2.6%
1/39
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.2%
1/82
|
5.1%
2/39
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/82
|
7.7%
3/39
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/82
|
5.1%
2/39
|
Additional Information
Dr. Obi Umeh, Vice President Global Medical Sciences
Cubist Pharmaceuticals, Inc.
Phone: 781-860-8415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Authorship on any primary publication of the results from this study will be based on contributions to study design, enrollment, data analysis, and interpretation of results. All investigators who enroll at least one subject will be acknowledged in any journal publication.
- Publication restrictions are in place
Restriction type: OTHER