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

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.
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Coordinator

SERVICIO ANDALUZ DE SALUD

Address

Avenida De La Constitucion 18
41071 Sevilla

Spain

Activity type

Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)

EU Contribution

€ 2 089 899,27

Administrative Contact

Maria Perales (Ms.)

Participants (9)

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UNIVERSITE PARIS-SUD

France

EU Contribution

€ 244 000

KLINIKUM DER UNIVERSITAET ZU KOELN

Germany

EU Contribution

€ 336 089

UNIVERSITA CATTOLICA DEL SACRO CUORE

Italy

EU Contribution

€ 1 054 992,85

ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON

Greece

EU Contribution

€ 976 850

FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA

Spain

EU Contribution

€ 324 044

SERVIZO GALEGO DE SAUDE

Spain

EU Contribution

€ 281 836

HALOTECH DNA, SL.

Spain

EU Contribution

€ 337 626

BIOMEDAL SL

Spain

EU Contribution

€ 337 626

CONSORCIO DE APOYO A LA INVESTIGACION BIOMEDICA EN RED

Spain

EU Contribution

€ 5 054,88

Project information

Grant agreement ID: 278232

Status

Closed project

  • Start date

    1 January 2012

  • End date

    31 December 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 721 719

  • EU contribution

    € 5 988 018

Coordinated by:

SERVICIO ANDALUZ DE SALUD

Spain