Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

Condition(s) targeted: Infection

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug); Ertapenem intravenous (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.

Official title: A Prospective, Randomized, Double Dummy, Double Blind, Multi-Center Trial Comparing the Safety and Efficacy of 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)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy variable for this trial is the clinical response 21 to 28 days after the completion of study drug therapy (Test of Cure visit).

Secondary outcome:

Clinical and bacteriological response on treatment Day 5 ± 1

Clinical and bacteriological response at the End-of-Therapy (EOT)

Bacteriological response at the TOC visit (21 28 days after EOT)

Clinical response at the TOC visit in subjects with a bacteriologically documented intra abdominal infection

Mortality attributable to intra abdominal infections at the time of the TOC visit (21 to 28 days after EOT)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Córdoba 5000, Argentina; Recruiting

Mendoza, Argentina; Recruiting

GENT 9000, Belgium; Recruiting

BRUXELLES - BRUSSEL 1070, Belgium; Recruiting

BRUXELLES - BRUSSEL 1090, Belgium; Recruiting

Ruse 7002, Bulgaria; Recruiting

Pleven 5800, Bulgaria; Recruiting

Sofia 1431, Bulgaria; Recruiting

Sofia 1606, Bulgaria; Recruiting

Tartu EE-51014, Estonia; Active, not recruiting

Tallinn 13419, Estonia; Recruiting

Kohtla-Jarve 30322, Estonia; Recruiting

AMILLY CEDEX 45207, France; Recruiting

BESANCON 25030, France; Recruiting

Kfar Saba 44281, Israel; Recruiting

Haifa 31048, Israel; Recruiting

Riga LV-1002, Latvia; Recruiting

Valmiera LV-4201, Latvia; Recruiting

Riga LV-1038, Latvia; Recruiting

Daugavpils LV-5417, Latvia; Recruiting

Liepaja 3402, Latvia; Recruiting

Rezekne, Latvia; Recruiting

Kaunas 45130, Lithuania; Recruiting

Vilnius 10207, Lithuania; Recruiting

Klaipeda LT-92231, Lithuania; Recruiting

Vilnius LT-04130, Lithuania; Recruiting

Bucharest, Romania; Recruiting

Timisoara 300748, Romania; Recruiting

Oradea, Romania; Recruiting

Brasov, Romania; Recruiting

Cluj-Napoca 400006, Romania; Recruiting

Moscow 115280, Russian Federation; Recruiting

Moscow 119048, Russian Federation; Recruiting

Smolensk 214019, Russian Federation; Recruiting

Madrid 28007, Spain; Recruiting

Heidelberg, Baden-Württemberg 69112, Germany; Recruiting

L'Hospitalet de Llobregat, Barcelona 08907, Spain; Recruiting

Beeskow, Brandenburg 15848, Germany; Recruiting

Florencio Varela, Buenos Aires 1888, Argentina; Recruiting

3 de Febrero, Buenos Aires 1657, Argentina; Recruiting

Merlo, Buenos Aires B1712FJN, Argentina; Recruiting

Ciudadela, Buenos Aires B1702FWM, Argentina; Recruiting

Buenos Aires, Capital Federal C1180AAX, Argentina; Recruiting

Buenos Aires, Capital Federal 1425, Argentina; Recruiting

Pretoria, Gauteng 0084, South Africa; Recruiting

Hannover, Niedersachsen 30625, Germany; Recruiting

Paderborn, Nordrhein-Westfalen 33098, Germany; Recruiting

Rio, Patras 265 00, Greece; Recruiting

Homburg, Saarland 66421, Germany; Recruiting

Rosario, Santa Fe, Argentina; Recruiting

Somerset West, Western Cape 7130, South Africa; Recruiting

Cape Town, Western Cape 7505, South Africa; Recruiting

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Starting date: July 2006
Ending date: February 2009
Last updated: February 5, 2009