Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

NCT00492726 | Completed Phase 3 Results

• 2 other identifiers: 119762006-000874-56
• Study Type: interventional
• Target: 804
• Locations: 13 countries
• Sites: 49

Brief Summary

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

Conditions

Infection

Keywords

Complicated Intra-Abdominal Infections

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population

  Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.

  21 to 28 days after completion of study drug therapy

Secondary Outcomes (9)

• Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population

  During treatment at day 5 +/- 1 day

• Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)

  During treatment at day 5 +/- 1 day

• Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population

  after 5 - 14 days of therapy

• Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)

  After 5 - 14 days of therapy

• Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)

  21 - 28 days after end of therapy

Study Arms (2)

Moxifloxacin (Avelox, BAY12-8039)

EXPERIMENTAL

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)

Ertapenem

ACTIVE COMPARATOR

Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.

Drug: Ertapenem intravenous

Interventions

Moxifloxacin (Avelox, BAY12-8039) DRUG

Moxifloxacin, 400mg, administered intravenously once daily

Moxifloxacin (Avelox, BAY12-8039)

Ertapenem intravenous DRUG

Active treatment: Ertapenem 1.0g, administered intravenously once daily

Ertapenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \</= 30 mL/min/1.73 m2
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (52)

Unknown Facility

Ciudadela, Buenos Aires, B1702FWM, Argentina

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De Febrero 3, Buenos Aires, 1657, Argentina

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Merlo, Buenos Aires, B1712FJN, Argentina

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San Juan Bautista, Buenos Aires, 1888, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1180AAX, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Mendoza, Mendoza Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Capital Federal, Argentina

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Bruxelles - Brussel, 1070, Belgium

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Bruxelles - Brussel, 1090, Belgium

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Ghent, 9000, Belgium

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Pleven, 5800, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Kohtla-Järve, 30322, Estonia

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Tallinn, EE-13419, Estonia

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Tartu, EE-51014, Estonia

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Amilly, 45207, France

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Besançon, 25000, France

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Beeskow, Brandenburg, 15848, Germany

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Hanover, Lower Saxony, 30625, Germany

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Paderborn, North Rhine-Westphalia, 33098, Germany

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Homburg, Saarland, 66424, Germany

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Rio Patras, 265 00, Greece

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Haifa, 31048, Israel

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Kfar Saba, 4428164, Israel

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Daugavpils, LV-5417, Latvia

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Liepāja, 3402, Latvia

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Rēzekne, Latvia

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Riga, 1002, Latvia

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Riga, LV-1038, Latvia

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Valmiera, LV-4201, Latvia

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Kaunas, 45130, Lithuania

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Klaipėda, LT-92231, Lithuania

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Vilnius, 10207, Lithuania

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Vilnius, LT-04130, Lithuania

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Brasov, Romania

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Bucharest, 022328, Romania

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Cluj-Napoca, 400006, Romania

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Oradea, Romania

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Timișoara, 300748, Romania

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Moscow, 115280, Russia

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Moscow, 119048, Russia

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Smolensk, 214019, Russia

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Cape Town, Cape, 7500, South Africa

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Pretoria, Gauteng, 0001, South Africa

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Somerset West, Western Cape, 7130, South Africa

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

• De Waele JJ, Tellado JM, Alder J, Reimnitz P, Jensen M, Hampel B, Arvis P. Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. Int J Antimicrob Agents. 2013 Jan;41(1):57-64. doi: 10.1016/j.ijantimicag.2012.08.013. Epub 2012 Nov 13.

  PMID: 23153963 RESULT

Related Links

• Click here and search for information of Bayer products for Europe

MeSH Terms

Conditions

Infections

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: July 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 7, 2014
• Results First Posted: March 3, 2010

Record last verified: 2014-11

Locations

RU (3); DE (5); IL (2); LI (4); ES (2); AR (9); LA (6); ZA (3); BE (3); GR (1); RO (5); BU (4); FR (2)