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Trial record 1 of 1 for:    NCT01292031
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Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB) (MagicBullet)

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ClinicalTrials.gov Identifier: NCT01292031
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Tracking Information
First Submitted Date  ICMJE February 2, 2011
First Posted Date  ICMJE February 9, 2011
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
Number of patients who die as a measure of efficacy [ Time Frame: 28 days ]
Demostrate that colistin iv. is not inferior to meropenen in empiric treatment of VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Number of patients with clinical healing as a measure of efficacy [ Time Frame: 28 days ]
    Demostrate that colistin is not inferior to meropenem in empiric treatment of VAP regarding efficacy: clinical healing in patients clinically evaluated
  • Microbiological resolution as a measure of microbiological efficacy [ Time Frame: 28 days ]
    Compare microbiological efficacy of treatment with colistin vs meropenen in VAP. The putative pathogen is eliminated from repeated culture of lower respiratory tract.
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 28 days ]
    The evaluation of security will be carried out through collection of adverse events that occur during the trial
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
  • Number of patients with clinical healing as a measure of efficacy [ Time Frame: 28 days ]
    Demostrate that colistin is not inferior to meropenem in empiric treatment of VAP regarding efficacy: clinical healing in patients clinically evaluated
  • Microbiological resolution as a measure of microbiological efficacy [ Time Frame: 28 days ]
    Compare microbiological efficacy of treatment with colistin vs meropenen in VAP. The putative pathogen is eliminated from repeated culture of lower respiratory tract.
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 28 days ]
    The evaluation of security will be carried out through collection of adverse events that occur during the trial
  • Relapse or recurrent infection as a measure of microbiological efficacy [ Time Frame: 28 days ]
    After initial eradication, the patient suffers a clinical and radiographic deterioration with the same organism that was responsible for the initial infection.
  • Superinfection as a measure of microbiological efficacy [ Time Frame: 28 days ]
    The patient has an infection that is similar to relapse or recurrent infection but involves a different or new organism.
  • Microbiological failure as a measure of microbiological efficacy [ Time Frame: 28 days ]
    The enrollment microorganism continues to appear in secretions of the lower respiratory tract throughout the study period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
Official Title  ICMJE Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB
Brief Summary
  1. To demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days and clinical healing in patients clinically evaluated.
  2. To compare the safety of treatment with colistin vs meropenem in VAP.
  3. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP
Detailed Description

Study drugs: Patients will be randomized a 1:1 rate and open label fashion to two interventions: group 1: colistin loading dose followed by colistin infusion iv/8h or group 2: meropenem 2 g/iv/ 8 h. The overall treatment time will be a minimum of 8 days.

Follow-up visits will be performed at baseline, 72 h, 8 days, the end of treatment, and 28 days from recruitment ICU discharge, hospital discharge or death.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventilator-associated Bacterial Pneumonia
Intervention  ICMJE
  • Drug: Colistin
    Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
  • Drug: Meropenem
    Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Study Arms  ICMJE
  • Experimental: Colistin
    Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion
    Intervention: Drug: Colistin
  • Active Comparator: Meropenem
    Meropenem 2 g/iv/ 8 h. 30 minutes infusion
    Intervention: Drug: Meropenem
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2016)
232
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2011)
400
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age ≥ 18 years with clinical and radiological criteria of VAP. The women of childbearing age (not surgically sterilized and in the period between menarche and 1 year after the menopause) must have a negative test of pregnancy in urine at the time of recruitment.

The patient or his/her legal representative must sign a document of informed consent approved by the Ethics Review Committee.

Exclusion Criteria:

Hypersensitivity to the two antimicrobials of the study (colistin/meropenem). Renal insufficiency in substitute treatment. Corporal weight <40 kg or >150 kg. Patients previously included in another clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece,   Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01292031
Other Study ID Numbers  ICMJE 2010-023310-31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Sponsor  ICMJE Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators  ICMJE European Commission
Investigators  ICMJE
Study Chair: José Miguel Cisneros-Herreros, PhD Andaluz Health Service
PRS Account Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP