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InfectionPhase 3NCT00492726

Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

A Phase 3 study testing Moxifloxacin (Avelox, BAY12-8039) and Ertapenem intravenous in people with Infection, run by Bayer at 52 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection
What is being tested?
Moxifloxacin (Avelox, BAY12-8039) and Ertapenem intravenous
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
804 participants
Where
52 sitesin 14 countries
Study dates
Jul 2006to Feb 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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
  • 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

Trial locations and contacts

52 sites in 14 countries.

52 sites in 14 countries

Argentina9 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1180AAX

  • Study site

    Capital Federal

  • Study site

    Ciudadela, Buenos Aires, B1702FWM

  • Study site

    Córdoba, Córdoba Province, 5000

  • Study site

    De Febrero 3, Buenos Aires, 1657

  • Study site

    Mendoza, Mendoza Province

  • Study site

    Merlo, Buenos Aires, B1712FJN

  • Study site

    Rosario, Santa Fe Province

  • Study site

    San Juan Bautista, Buenos Aires, 1888

Other trials in Argentina

Latvia6 sites

  • Study site

    Daugavpils, LV-5417

  • Study site

    Liepāja, 3402

  • Study site

    Rēzekne

  • Study site

    Riga, 1002

  • Study site

    Riga, LV-1038

  • Study site

    Valmiera, LV-4201

Other trials in Latvia

Germany5 sites

  • Study site

    Beeskow, Brandenburg, 15848

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Homburg, Saarland, 66424

  • Study site

    Paderborn, North Rhine-Westphalia, 33098

Other trials in Germany

Romania5 sites

  • Study site

    Brasov

  • Study site

    Bucharest, 022328

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Oradea

  • Study site

    Timișoara, 300748

Other trials in Romania

Bulgaria4 sites

  • Study site

    Pleven, 5800

  • Study site

    Rousse, 7002

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1606

Other trials in Bulgaria

Lithuania4 sites

  • Study site

    Kaunas, 45130

  • Study site

    Klaipėda, LT-92231

  • Study site

    Vilnius, 10207

  • Study site

    Vilnius, LT-04130

Other trials in Lithuania

Belgium3 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1090

  • Study site

    Ghent, 9000

Other trials in Belgium

Estonia3 sites

  • Study site

    Kohtla-Järve, 30322

  • Study site

    Tallinn, EE-13419

  • Study site

    Tartu, EE-51014

Other trials in Estonia

Russia3 sites

  • Study site

    Moscow, 115280

  • Study site

    Moscow, 119048

  • Study site

    Smolensk, 214019

Other trials in Russia

South Africa3 sites

  • Study site

    Cape Town, Cape, 7500

  • Study site

    Pretoria, Gauteng, 0001

  • Study site

    Somerset West, Western Cape, 7130

Other trials in South Africa

France2 sites

  • Study site

    Amilly, 45207

  • Study site

    Besançon, 25000

Other trials in France

Israel2 sites

  • Study site

    Haifa, 31048

  • Study site

    Kfar Saba, 4428164

Other trials in Israel

Spain2 sites

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, Madrid, 28007

Other trials in Spain

Greece1 site

  • Study site

    Rio Patras, 265 00

Other trials in Greece

About this study

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)

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

Conditions
Infection
Being tested
Moxifloxacin (Avelox, BAY12-8039), Ertapenem intravenous
Keywords
Complicated Intra-Abdominal Infections
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moxifloxacin (Avelox, BAY12-8039)Drug

    Moxifloxacin, 400mg, administered intravenously once daily

  • Ertapenem intravenousDrug

    Active treatment: Ertapenem 1.0g, administered intravenously once daily

Study groups in NCT00492726
Study groupRoleWhat they receive
Moxifloxacin (Avelox, BAY12-8039)ExperimentalSubjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Receives: Drug: Moxifloxacin (Avelox, BAY12-8039)
ErtapenemActive comparatorSubject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Receives: Drug: Ertapenem intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 21 to 28 days after completion of study drug therapy

Secondary outcomes (9)

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

    Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.

    Measured: During treatment at day 5 +/- 1 day

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

    Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.

    Measured: During treatment at day 5 +/- 1 day

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

    Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.

    Measured: after 5 - 14 days of therapy

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

    Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.

    Measured: After 5 - 14 days of therapy

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

    Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection' - additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.

    Measured: 21 - 28 days after end of therapy

  6. Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)

    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.

    Measured: 21 - 28 days after end of therapy

  7. Number of Subjects Who Died Due to Intra-abdominal Infections

    Number of subjects who had died due to intra abdominal infections by the time of TOC visit.

    Measured: 21 - 28 days after end of treatment at TOC Visit

  8. Duration of Hospitalization

    Duration of hospitalization in the per protocol population.

    Measured: From the first admission date to the discharge date (from 4 to 71 days after start of study medication)

  9. Duration of Hospitalization Postoperatively

    Duration of hospitalization after the first surgery until discharge in the per protocol population.

    Measured: Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startJul 2006
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
804 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00492726
Sponsor's protocol ID
11976
Other IDs
2006-000874-56
Status last verified
Nov 2014
First submitted
26 Jun 2007
Last updated
7 Nov 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 23153963

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moxifloxacin (Avelox, BAY12-8039) and Ertapenem intravenous in people with Infection, run by Bayer at 52 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Argentina, Latvia, Germany, Romania, Bulgaria and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00492726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014.

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