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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00492726 |
Purpose
A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
| Condition | Intervention | Phase |
|---|---|---|
|
Infection |
Drug: Moxifloxacin (Avelox, BAY12-8039) Drug: Ertapenem intravenous |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Double-dummy, Double-blind, Multicenter Trial Comparing the Safety and Efficacy of Intravenous Moxifloxacin 400 mg IV QD 24 Hours to That of Ertapenem 1.0 g IV QD 24 Hours for 5 to 14 Days for the Treatment of Subjects With Complicated Intra-abdominal Infections (PROMISE Study) |
| Enrollment: | 804 |
| Study Start Date: | July 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Moxifloxacin (Avelox, BAY 12-8039)
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Drug: Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin, 400mg, administered intravenously once daily
|
|
Active Comparator: Ertapenem
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
Drug: Ertapenem intravenous
Active treatment: Ertapenem 1.0g, administered intravenously once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Confirmed or suspected intra abdominal infection defined as follows:
For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following:
Subjects enrolled on the basis of a suspected intra abdominal infection must have:
Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms:
At least two of the following SIRS criteria:
Exclusion Criteria:
Contacts and Locations
Show 52 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00492726 History of Changes |
| Other Study ID Numbers: | 11976, EudraCT: 2006-000874-56 |
| Study First Received: | June 26, 2007 |
| Results First Received: | February 11, 2010 |
| Last Updated: | May 5, 2011 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
|
Complicated Intra-Abdominal Infections |
|
Moxifloxacin Ertapenem Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined |
Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Bacterial Agents |