Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00492726
• Date of registration: 26/06/2007
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem
• Scientific 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)
• Date of first enrolment: July 2006
• Target sample size: 804
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00492726
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Belgium, Bulgaria, Estonia, France, Germany, Greece, Israel, Latvia, Lithuania, Romania, Russian Federation, South Africa, Spain

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Hospitalized men or women >/=18 years of age

- Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5
full days but not exceeding 14 days

- Ability to provide documented and signed written informed consent

- 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:

- Gross peritoneal inflammation with purulent exudates (i.e. peritonitis)

- Intra abdominal abscess

- Macroscopic intestinal perforation with localized or diffuse peritonitis

- 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:

- Symptoms referable to the abdominal cavity (e.g. anorexia, nausea, vomiting
or pain), lasting for at least 24 hours

- Tenderness (with or without rebound), involuntary guarding, absent or
diminished bowel sounds, or abdominal wall rigidity

- At least two of the following SIRS criteria:

- Temperature > 38.0°C rectal or tympanic membrane, or temperature < 36.0°C
rectal or tympanic

- Heart rate > 90/min

- Respiratory rate > 20/min

- WBC >12,000 cells/mm3 or < 4,000 cells/ mm3

- The subject must be scheduled for a surgical procedure (laparotomy or
laparoscopy) within 24 hours of enrollment of the study

Exclusion Criteria:

- Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type
of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the
excipients

- Women who are pregnant or lactating or in whom pregnancy cannot be excluded

- History of tendon disease/disorder related to quinolone treatment

- Known congenital or documented acquired QT prolongation; uncorrected hypokalemia;
clinically relevant bradycardia; clinically relevant heart failure with reduced left
ventricular ejection fraction; previous history of symptomatic arrhythmias

- Concomitant use of any of the following drugs, reported to increase the QT interval:
antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or
antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide),
neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride),
tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin
IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics
(terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil,
diphemanil)

- Known severe end stage liver disease

- Creatinine clearance
- Systemic antibacterial therapy administered for more than 24 hours within 7 days of
enrollment

- Need for systemic antibacterial therapy with agents other than those described in the
study protocol

- Indwelling peritoneal catheter

- Pre existing ascites and presumed spontaneous bacterial peritonitis

- Perforation of the stomach or duodenum, if the duration of perforation is less than 24
hours or if operated on within 24 hours of perforation

- Perforation of the small bowel (excluding the duodenum) or large bowel, if the
duration of perforation is less than 12 hours or if operated on within 12 hours of
perforation

- All pancreatic processes including pancreatic sepsis, peri-pancreatic sepsis, or an
intra abdominal infection secondary to pancreatitis

- Liver and splenic abscess

- Transmural bowel ischemia or necrosis without perforation or established peritonitis
or abscess

- Acute and gangrenous cholecystitis without perforation

- Acute cholangitis

- Early acute, suppurative, or gangrenous non-perforated appendicitis

- Subjects requiring antibiotic irrigations of the abdominal cavity or surgical wound

- Treatment with "open abdomen" or marsupialization, or multiple planned re laparotomies

- Infections originating from the female genital tract

- Peri-nephric infections

- Evidence of sepsis with shock requiring the administration of vasopressors for more
than 4 consecutive hours

- Known rapidly fatal underlying disease (death expected within 6 months)

- Neutropenia (neutrophil count < 1,000/mL) caused by immunosuppressive therapy or
malignancy

- Receiving chronic treatment with known immunosuppressant therapy (including chronic
treatment with > 15 mg/day of systemic prednisone or equivalent)

- Subjects known to have AIDS (CD4 count < 200/mL) or HIV seropositives who are
receiving HAART (HIV positive subjects may be included. HIV testing is not required
for this study protocol)

- Subjects with a malignant or pre malignant hematological condition, including
Hodgkin's disease and non-Hodgkin lymphoma (subjects with solid tumor can be included
in the study)

- Subjects with a Body Mass Index >/= 45 kg/m2

- Previous enrollment in this study

- Participation in any clinical investigational drug study within the previous 4 weeks



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Infection

Intervention(s)

Drug: Moxifloxacin (Avelox, BAY12-8039)

Drug: Ertapenem intravenous

Primary Outcome(s)

Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population [Time Frame: 21 to 28 days after completion of study drug therapy]

Secondary Outcome(s)

Number of Subjects Who Died Due to Intra-abdominal Infections [Time Frame: 21 - 28 days after end of treatment at TOC Visit]

Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) [Time Frame: During treatment at day 5 +/- 1 day]

Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population [Time Frame: During treatment at day 5 +/- 1 day]

Duration of Hospitalization [Time Frame: From the first admission date to the discharge date (from 4 to 71 days after start of study medication)]

Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) [Time Frame: 21 - 28 days after end of therapy]

Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) [Time Frame: 21 - 28 days after end of therapy]

Duration of Hospitalization Postoperatively [Time Frame: Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)]

Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) [Time Frame: After 5 - 14 days of therapy]

Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population [Time Frame: after 5 - 14 days of therapy]

Secondary ID(s)

11976

2006-000874-56

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/03/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00492726