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
city: SEVILLA
postcode: 41071

contact info
Titolo: Ms.
Nome: Maria
Cognome: Perales
Email: send email
Telefono: 34955013645
Fax: 34955013292

 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

# participant  country  role  EC contrib. [€] 
1    Servicio Andaluz de Salud

 Organization address address: AVENIDA DE LA CONSTITUCION 18
city: SEVILLA
postcode: 41071

contact info
Titolo: Ms.
Nome: Maria
Cognome: Perales
Email: send email
Telefono: 34955013645
Fax: 34955013292

ES (SEVILLA) coordinator 2˙089˙899.20
2    UNIVERSITA CATTOLICA DEL SACRO CUORE

 Organization address address: Largo Agostino Gemelli 1
city: MILANO
postcode: 20123

contact info
Titolo: Mr.
Nome: Filippo
Cognome: Leone
Email: send email
Telefono: +39 06 30 15 6099
Fax: +39 06 30 15 6803

IT (MILANO) participant 1˙054˙992.90
3    NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS

 Organization address address: CHRISTOU LADA 6
city: ATHENS
postcode: 10561

contact info
Titolo: Ms.
Nome: Efi
Cognome: Kafentzi
Email: send email
Telefono: 302104000000
Fax: 302104000000

EL (ATHENS) participant 976˙850.00
4    "HALOTECH DNA, SL."

 Organization address address: Calle FARADAY 7
city: MADRID
postcode: 28049

contact info
Titolo: Dr.
Nome: Miguel Angel
Cognome: Ramirez
Email: send email
Telefono: 34912796260

ES (MADRID) participant 337˙626.00
5    BIOMEDAL SL

 Organization address address: CUBA 1-1B
city: SEVILLA
postcode: 41100

contact info
Titolo: Dr.
Nome: ángel
Cognome: Cebolla Ramírez
Email: send email
Telefono: 34954081276
Fax: 34954081279

ES (SEVILLA) participant 337˙626.00
6    KLINIKUM DER UNIVERSITAET ZU KOELN

 Organization address address: Kerpener Strasse 62
city: KOELN
postcode: 50937

contact info
Titolo: Prof.
Nome: Harald
Cognome: Seifert
Email: send email
Telefono: +49 221 478 32009
Fax: +49 221 478 32035

DE (KOELN) participant 336˙089.00
7    FUNDACIO PRIVADA CLINIC PER A LA RECERCA BIOMEDICA

 Organization address address: CARRER ROSSELLO 149-153
city: BARCELONA
postcode: 8029

contact info
Titolo: Prof.
Nome: Jordi
Cognome: Vila Estape
Email: send email
Telefono: 34638257973

ES (BARCELONA) participant 324˙044.00
8    SERVIZO GALEGO DE SAUDE

 Organization address city: Santiago de Compostela
postcode: 15703

contact info
Titolo: Prof.
Nome: German
Cognome: Bou Arevalo
Email: send email
Telefono: +34 981 176087
Fax: +34 981 176097

ES (Santiago de Compostela) participant 281˙836.00
9    UNIVERSITE PARIS-SUD

 Organization address address: RUE GEORGES CLEMENCEAU 15
city: ORSAY
postcode: 91405

contact info
Titolo: Ms.
Nome: Sandra
Cognome: Mereu
Email: send email
Telefono: +33 1 69 15 37 22
Fax: +33 1 69 15 55 99

FR (ORSAY) participant 244˙000.00
10    CONSORCIO DE APOYO A LA INVESTIGACION BIOMEDICA EN RED

 Organization address address: CALLE SINESIO DELGADO 6
city: MADRID
postcode: 28029

contact info
Titolo: Ms.
Nome: Almudena
Cognome: Moreno
Email: send email
Telefono: +34 918222490

ES (MADRID) participant 5˙054.88

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

therapy    ventilator    pneumonia    conventional    too    techniques    gnb    severe    team    etiology    treatment    alterations    appearance    clinical    negative    context    empirical    trial    resistant    caused    mortality    safety    pathogens    colistin    intestinal    susceptibility    vitro    data    choice    strains    inappropriate    antibiotics    adquired    multidrug    carbapenem    hours    meropenem    hospital    resistance    empiric    antibiotic    countries    mdr    microbiological    vap    drug    unknown    efficacy    determine    antimicrobial    additional    gram    infections    bacilli    randomized    impact    hospitals    greatest    constitute    microbiome    magicbullet   

 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.

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