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Colistin and Rifampicin for MDR-Acinetobacter

NCT01577862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2012-04-16

No results posted yet for this study

Summary

Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. However, colistin is not registered for this indication. The addition of rifampicin to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been studied in comparison with colistin alone.

The purpose of this randomised, open-label, multicentre clinical trial is to assess whether the association of colistin and rifampicin reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone.

The trial will enroll 210 patients from intensive care units (ICU) of five tertiary care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin alone (control arm) or colistin plus rifampicin (experimental arm).

Primary end point is overall mortality, defined as death occurring within 30 days from randomisation.

Secondary end points will be disease-specific death, microbiological eradication, hospitalization length, emergence of resistance to colistin during treatment.

Conditions

  • Infection Due to Resistant Bacteria
  • Pneumonia, Ventilator-Associated
  • Hospital Acquired Pneumonia
  • Infection of Bloodstream
  • Infectious Disease of Abdomen

Interventions

DRUG

Colistin

2 million units every 8 hours intravenously for at least 10 and up to a maximum of 21 days

DRUG

Rifampicin

600 mg every 12 hours intravenously

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Riccardo Utili, MD · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-08-31
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577862 on ClinicalTrials.gov