Ventilator-associated Bacterial PneumoniaPhase 3MagicBulletNCT01292031
Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
A Phase 3 study testing Colistin and Meropenem in people with Ventilator-associated Bacterial Pneumonia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 33 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Bacterial Pneumonia
- What is being tested?
- Colistin and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 33 sitesin 3 countries
- Study dates
- May 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
Spain17 sites
Complexo Hospitalario A Coruña
A Coruña, 15006
Hospital Puerta del Mar Universidad de Cádiz
Cadiz
Hospital General Universitario Santa Lucía
Cartagena
Hospital General de Ciudad Real
Ciudad Real
University Hospital Reina Sofía
Córdoba, Córdoba, 14004
University Hospital Juan Ramón Jiménez
Huelva, Huelva, 21005
Hospital de Jerez
Jerez de la Frontera
Hospital 12 de Octubre
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Carlos Haya Universidad de Málaga
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
Complexo Hospitalario de Orense
Ourense
Hospital Marqués de Valdecillas
Santander
Hospital Virgen del Rocío Sevilla
Seville, 41013
Hospital Mutua de Terrassa
Tarrasa, 08221
La Fe Universidad de Valencia
Valencia, 46009
Hospital Dr. Peset
Valencia, 46017
Greece10 sites
University Hospital of Alexandroupolis, Medical School University of Thrace
Alexandroupoli
Evagelismos Hospital, Medical School University of Athens
Athens
General Hospital of Larissa, Thessalia University
Athens
Sotiria Hospital, Medical School University of Athens
Athens
University Hospital Ag. Anargiri, Nurshing School University of Athens
Athens
University Hospital ATTIKON, Medical School University of Athens
Athens
University Hospital of Larissa, Medical School University of Athens
Athens
University Hospital of Heraklion, Medical School University of Crete
Crete
University Hospital of Ioannina, Medical School, University of Ipirus
Ioannina
Papanikolaou Hospital,
Thessaloniki
Italy6 sites
AO Ospedale Niguarda Ca Granda Milano
Milan
University of Napoli Federico II
Naples
AOU Cisanello- Pisa
Pisa
Azienda OspedalieraSant'Andrea
Roma, Rome
Policlinico Universitario A. Gemelli
Roma
S.Giovanni Battista Molinette Hospital Turin
Turin
About this study
Official title: Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB
- 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
Read the 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.
- Being tested
- Colistin, Meropenem
- Keywords
- VAP, MDR-GNB, colistin, meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
MeropenemDrug
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
| Study group | Role | What they receive |
|---|---|---|
| Colistin | Experimental | Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion Receives: Drug: Colistin |
| Meropenem | Active comparator | Meropenem 2 g/iv/ 8 h. 30 minutes infusion Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (3)
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
Measured: 28 days
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.
Measured: 28 days
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated Bacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- José Miguel Cisneros-Herreros, PhD, Study chair, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292031
- Sponsor's protocol ID
- 2010-023310-31
- Acronym
- MagicBullet
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2011
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31779711Rosso-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.
PubMed 25872790
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB
- ClinicalTrials.gov ID
- NCT01292031
- Acronym / sponsor ID
- MagicBullet / 2010-023310-31
- Keywords
- VAP, MDR-GNB, colistin, meropenem
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistin | Experimental | Drug: ColistinColistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion |
| Meropenem | Active comparator | Drug: MeropenemMeropenem 2 g/iv/ 8 h. 30 minutes infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColistinColistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion | Drug | Colistin |
| MeropenemMeropenem 2 g/iv/ 8 h. 30 minutes infusion | Drug | Meropenem |
Primary outcome
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
3 secondary outcomes
Number of patients with clinical healing as a measure of efficacy
Time frame: 28 days
Microbiological resolution as a measure of microbiological efficacy
Time frame: 28 days
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Derived from this study: PubMed 31779711Cisneros 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.
- Derived from this study: PubMed 25872790Rosso-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Miguel Cisneros-Herreros, PhD study chair
Andaluz Health Service
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colistin and Meropenem in people with Ventilator-associated Bacterial Pneumonia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 33 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain, Greece, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who die as a measure of efficacy (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292031, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.