Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB) (MagicBullet)
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| ClinicalTrials.gov Identifier: NCT01292031 |
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Recruitment Status :
Completed
First Posted : February 9, 2011
Last Update Posted : February 3, 2016
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- 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.
- To compare the safety of treatment with colistin vs meropenem in VAP.
- 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 |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Colistin
Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion
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Drug: Colistin
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion |
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Active Comparator: Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
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Drug: Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion |
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
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| Study Chair: | José Miguel Cisneros-Herreros, PhD | Andaluz Health Service |
| 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 |
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VAP MDR-GNB colistin meropenem |
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Pneumonia Pneumonia, Bacterial Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |
Bacterial Infections Bacterial Infections and Mycoses Meropenem Colistin Anti-Bacterial Agents Anti-Infective Agents |