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

Ventilator-associated Bacterial Pneumonia Clinical Trial

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Official title:

Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292031
• Other study ID #: 2010-023310-31
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2011
• Last updated: February 2, 2016
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical 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. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Ventilator-Associated
• Ventilator-associated Bacterial Pneumonia

Intervention

Drug:
• Colistin
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
• Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	European Commission

Countries where clinical trial is conducted

Greece,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days	Yes
Secondary	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	28 days	Yes
Secondary	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.	28 days	No
Secondary	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	28 days	Yes

External Links

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