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Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB) (MagicBullet)

Primary Purpose

Ventilator-associated Bacterial Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Colistin
Meropenem
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator-associated Bacterial Pneumonia focused on measuring VAP, MDR-GNB, colistin, meropenem

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Alexandroupolis, Medical School University of Thrace
  • Evagelismos Hospital, Medical School University of Athens
  • General Hospital of Larissa, Thessalia University
  • Sotiria Hospital, Medical School University of Athens
  • University Hospital Ag. Anargiri, Nurshing School University of Athens
  • University Hospital ATTIKON, Medical School University of Athens
  • University Hospital of Larissa, Medical School University of Athens
  • University Hospital of Heraklion, Medical School University of Crete
  • University Hospital of Ioannina, Medical School, University of Ipirus
  • Papanikolaou Hospital,
  • Azienda OspedalieraSant'Andrea
  • AO Ospedale Niguarda Ca Granda Milano
  • University of Napoli Federico II
  • AOU Cisanello- Pisa
  • Policlinico Universitario A. Gemelli
  • S.Giovanni Battista Molinette Hospital Turin
  • Complexo Hospitalario A Coruña
  • Hospital General Universitario Santa Lucía
  • Hospital General de Ciudad Real
  • Hospital Puerta del Mar Universidad de Cádiz
  • University Hospital Reina Sofía
  • University Hospital Juan Ramón Jiménez
  • Hospital de Jerez
  • Hospital 12 de Octubre
  • Hospital Clínico San Carlos
  • Hospital Carlos Haya Universidad de Málaga
  • Hospital Universitario Virgen de la Victoria
  • Complexo Hospitalario de Orense
  • Hospital Marqués de Valdecillas
  • Hospital Virgen del Rocío Sevilla
  • Hospital Mutua de Terrassa
  • La Fe Universidad de Valencia
  • Hospital Dr. Peset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Colistin

Meropenem

Arm Description

Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion

Meropenem 2 g/iv/ 8 h. 30 minutes infusion

Outcomes

Primary Outcome Measures

Number of patients who die as a measure of efficacy
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

Number of patients with clinical healing as a measure of efficacy
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
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
The evaluation of security will be carried out through collection of adverse events that occur during the trial

Full Information

First Posted
February 2, 2011
Last Updated
February 2, 2016
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01292031
Brief Title
Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
Acronym
MagicBullet
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
European Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Bacterial Pneumonia
Keywords
VAP, MDR-GNB, colistin, meropenem

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colistin
Arm Type
Experimental
Arm Description
Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Arm Title
Meropenem
Arm Type
Active Comparator
Arm Description
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Intervention Type
Drug
Intervention Name(s)
Colistin
Intervention Description
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Intervention Type
Drug
Intervention Name(s)
Meropenem
Intervention Description
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Primary Outcome Measure Information:
Title
Number of patients who die as a measure of efficacy
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of patients with clinical healing as a measure of efficacy
Description
Demostrate that colistin is not inferior to meropenem in empiric treatment of VAP regarding efficacy: clinical healing in patients clinically evaluated
Time Frame
28 days
Title
Microbiological resolution as a measure of microbiological efficacy
Description
Compare microbiological efficacy of treatment with colistin vs meropenen in VAP. The putative pathogen is eliminated from repeated culture of lower respiratory tract.
Time Frame
28 days
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
The evaluation of security will be carried out through collection of adverse events that occur during the trial
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Miguel Cisneros-Herreros, PhD
Organizational Affiliation
Andaluz Health Service
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Alexandroupolis, Medical School University of Thrace
City
Alexandroupolis
Country
Greece
Facility Name
Evagelismos Hospital, Medical School University of Athens
City
Athens
Country
Greece
Facility Name
General Hospital of Larissa, Thessalia University
City
Athens
Country
Greece
Facility Name
Sotiria Hospital, Medical School University of Athens
City
Athens
Country
Greece
Facility Name
University Hospital Ag. Anargiri, Nurshing School University of Athens
City
Athens
Country
Greece
Facility Name
University Hospital ATTIKON, Medical School University of Athens
City
Athens
Country
Greece
Facility Name
University Hospital of Larissa, Medical School University of Athens
City
Athens
Country
Greece
Facility Name
University Hospital of Heraklion, Medical School University of Crete
City
Crete
Country
Greece
Facility Name
University Hospital of Ioannina, Medical School, University of Ipirus
City
Ioannina
Country
Greece
Facility Name
Papanikolaou Hospital,
City
Thessaloniki
Country
Greece
Facility Name
Azienda OspedalieraSant'Andrea
City
Roma
State/Province
Rome
Country
Italy
Facility Name
AO Ospedale Niguarda Ca Granda Milano
City
Milan
Country
Italy
Facility Name
University of Napoli Federico II
City
Napoli
Country
Italy
Facility Name
AOU Cisanello- Pisa
City
Pisa
Country
Italy
Facility Name
Policlinico Universitario A. Gemelli
City
Roma
Country
Italy
Facility Name
S.Giovanni Battista Molinette Hospital Turin
City
Turin
Country
Italy
Facility Name
Complexo Hospitalario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario Santa Lucía
City
Cartagena
Country
Spain
Facility Name
Hospital General de Ciudad Real
City
Ciudad Real
Country
Spain
Facility Name
Hospital Puerta del Mar Universidad de Cádiz
City
Cádiz
Country
Spain
Facility Name
University Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
University Hospital Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Carlos Haya Universidad de Málaga
City
Málaga
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Complexo Hospitalario de Orense
City
Orense
Country
Spain
Facility Name
Hospital Marqués de Valdecillas
City
Santander
Country
Spain
Facility Name
Hospital Virgen del Rocío Sevilla
City
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Tarrasa
ZIP/Postal Code
08221
Country
Spain
Facility Name
La Fe Universidad de Valencia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31779711
Citation
Cisneros JM, Rosso-Fernandez CM, Roca-Oporto C, De Pascale G, Jimenez-Jorge S, Fernandez-Hinojosa E, Matthaiou DK, Ramirez P, Diaz-Miguel RO, Estella A, Antonelli M, Dimopoulos G, Garnacho-Montero J; Magic Bullet Working Group WP1. Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial. Crit Care. 2019 Nov 28;23(1):383. doi: 10.1186/s13054-019-2627-y.
Results Reference
derived
PubMed Identifier
25872790
Citation
Rosso-Fernandez C, Garnacho-Montero J, Antonelli M, Dimopoulos G, Cisneros JM; MagicBullet study group. Safety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics: study protocol for a randomized controlled trial. Trials. 2015 Mar 20;16:102. doi: 10.1186/s13063-015-0614-4.
Results Reference
derived

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Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)

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