MAGICBULLET: Optimisation of treatment with off-patent antimicrobial agents of ventilator-associated pneumonia (VAP).

Project reference: 278232

Duration: From 2012-01-01 to 2015-12-31

Total cost: EUR 7 721 719

EU contribution: EUR 5 988 018

Objective: Background. Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context, the empirical treatment of choice for VAP is unknown. Colistin, and old drug, is now the antimicrobial with greatest in vitro activity against MDR-GNB. However, no randomized clinical trial with colistin has been carried out. Additional aspects of colistin are also not well known, such as the appearance of resistant strains or alterations in the intestinal microbiome during treatment. Furthermore, conventional microbiological techniques take 48 to 72 hours to identify pathogens and determine their susceptibility. This is too long if empiric treatment is inappropriate.Objetives. The overall goal is the optimisation of the treatment of VAP caused by MDR-GNB, by defining a gold standard empiric therapy and reducing the period of time needed for the determination of the etiology and susceptibility of pathogens.Methods. MagicBullet proposes a randomized, open label, multicenter, clinical trial to compare the safety and efficacy of colistin vs. meropenem, both combined with levofloxacin, for empirical treatment of VAP. The pharmacokinetic and pharmacodynamic characteristics of colistin will be determined. Evaluation of the impact of the both treatments in the intestinal microbiome of patients and in the Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrug-resistant gramnegative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context, the empirical treatment of choice for VAP is unknown. Colistin, and old drug, is now the antimicrobial with greatest in vitro activity against MDR-GNB. However, no randomized clinical trial with colistin has been carried out. Additional aspects of colistin are also not well known, such as the appearance of resistant strains or alterations in the intestinal microbiome during treatment. Furthermore, conventional microbiological techniques take 48 to 72 hours to identify pathogens and determine their susceptibility. This is too long if empiric treatment is inappropriate.

Participants:

UNIVERSITE PARIS-SUD

France

Rue Georges Clemenceau 15

ORSAY, France

Administrative contact: Sandra Mereu

Tel.: +33 1 69 15 37 22

Fax: +33 1 69 15 55 99

KLINIKUM DER UNIVERSITAET ZU KOELN

Germany

Kerpener Strasse 62

KOELN, Germany

Administrative contact: Harald Seifert

Tel.: +49 221 4

country :Spain

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