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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

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

Condition or disease Intervention/treatment Phase
Ventilator-associated Bacterial Pneumonia Drug: Colistin Drug: Meropenem Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB
Study Start Date : May 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Colistin
Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Drug: Colistin
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion

Active Comparator: Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Drug: Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292031


Locations
Show Show 33 study locations
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
European Commission
Investigators
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Study Chair: José Miguel Cisneros-Herreros, PhD Andaluz Health Service

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01292031    
Other Study ID Numbers: 2010-023310-31
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
VAP
MDR-GNB
colistin
meropenem
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Meropenem
Colistin
Anti-Bacterial Agents
Anti-Infective Agents