MAGICBULLET
Optimisation of treatment with off-patent antimicrobial agents of ventilator-associated pneumonia (VAP)
| Coordinatore | Servicio Andaluz de Salud
Organization address
address: AVENIDA DE LA CONSTITUCION 18 contact info |
| Nazionalità Coordinatore | Spain [ES] |
| Totale costo | 7˙721˙719 € |
| EC contributo | 5˙988˙018 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2011-two-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2012 |
| Periodo (anno-mese-giorno) | 2012-01-01 - 2015-12-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
Servicio Andaluz de Salud
Organization address
address: AVENIDA DE LA CONSTITUCION 18 contact info |
ES (SEVILLA) | coordinator | 2˙089˙899.20 |
| 2 |
UNIVERSITA CATTOLICA DEL SACRO CUORE
Organization address
address: Largo Agostino Gemelli 1 contact info |
IT (MILANO) | participant | 1˙054˙992.90 |
| 3 |
NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS
Organization address
address: CHRISTOU LADA 6 contact info |
EL (ATHENS) | participant | 976˙850.00 |
| 4 |
"HALOTECH DNA, SL."
Organization address
address: Calle FARADAY 7 contact info |
ES (MADRID) | participant | 337˙626.00 |
| 5 |
BIOMEDAL SL
Organization address
address: CUBA 1-1B contact info |
ES (SEVILLA) | participant | 337˙626.00 |
| 6 |
KLINIKUM DER UNIVERSITAET ZU KOELN
Organization address
address: Kerpener Strasse 62 contact info |
DE (KOELN) | participant | 336˙089.00 |
| 7 |
FUNDACIO PRIVADA CLINIC PER A LA RECERCA BIOMEDICA
Organization address
address: CARRER ROSSELLO 149-153 contact info |
ES (BARCELONA) | participant | 324˙044.00 |
| 8 |
SERVIZO GALEGO DE SAUDE
Organization address
city: Santiago de Compostela contact info |
ES (Santiago de Compostela) | participant | 281˙836.00 |
| 9 |
UNIVERSITE PARIS-SUD
Organization address
address: RUE GEORGES CLEMENCEAU 15 contact info |
FR (ORSAY) | participant | 244˙000.00 |
| 10 |
CONSORCIO DE APOYO A LA INVESTIGACION BIOMEDICA EN RED
Organization address
address: CALLE SINESIO DELGADO 6 contact info |
ES (MADRID) | participant | 5˙054.88 |
Mappa
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Obiettivo del progetto (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.'
Introduzione (Teaser)
Anti-microbial resistance constitutes a serious health issue and is usually encountered in hospital-acquired infections such as ventilator-associated pneumonia (VAP). A European clinical trial is testing the efficacy of an 'old' antibiotic, colistin, against such antibiotic-resistant pathogens.
Descrizione progetto (Article)
VAP is caused by multidrug-resistant gram-negative bacilli (MDR-GNB), and current clinical guidelines recommend the use of carbapenem antibiotics.
However, the resistance of these microorganisms to carbapenem antibiotics hampers therapy and leads to prolonged hospitalisation and mortality.
The antibiotic colistin represents a promising alternative for eradicating MDR-GNB and treating VAP. It has been around for decades but there are no clinical trial data on its dosage and potential side-effects. To this end, the EU-funded http://www.magicbullet7fp.eu (MAGICBULLET) project is conducting a clinical trial to determine the safety and efficacy of colistin in comparison to the off-patent drug meropenem.
Bringing together a team with both clinical and scientific expertise, the MAGICBULLET consortium will cover eight European university hospitals and over 30 hospitals in Greece, Spain and Italy where VAP has a high incidence. Partners are determining the pharmacokinetics and pharmacodynamics of colistin, and aim to come up with a new improved dose. A study on the impact of colistin on intestinal microbiota is also being conducted.
The MAGICBULLET team is currently working on a polymerase chain reaction-based technique for the early genetic identification of MDR-GNB strains for effective treatment. Antimicrobial susceptibility tests are also being developed to facilitate prompt diagnosis.
Taken together, MAGICBULLET aims to replace current empirical strategies for VAP treatment with evidence-based alternatives. The clinical data on colistin will help optimise the treatment for VAP and hopefully open up new avenues for tackling antibiotic-resistant pathogens.