PMID- 28114979
OWN - NLM
STAT- MEDLINE
DCOM- 20180305
LR  - 20201209
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 18
IP  - 1
DP  - 2017 Jan 23
TI  - Impact of the duration of antibiotics on clinical events in patients with 
      Pseudomonas aeruginosa ventilator-associated pneumonia: study protocol for a 
      randomized controlled study.
PG  - 37
LID - 10.1186/s13063-017-1780-3 [doi]
LID - 37
AB  - BACKGROUND: Ventilator-associated pneumonia (VAP) accounts for 25% of infections 
      in intensive care units. Compared to a long duration (LD) of antibiotic therapy, 
      a short duration (SD) has a comparable clinical efficacy with less antibiotic use 
      and less multidrug-resistant (MDR) pathogen emergence, with the exception of 
      documented VAP of non-fermenting Gram-negative bacilli (NF-GNB), including 
      Pseudomonas aeruginosa (PA). These results have led the American Thoracic Society 
      to recommend SD therapy for VAP, except for PA-VAP. Thus the beneficial effect of 
      SD therapy in PA-VAP is still a matter of debate. We aimed to assess the 
      non-inferiority of a short duration of antibiotics (8 days) versus prolonged 
      antibiotic therapy (15 days) in PA-VAP. METHODS/DESIGN: The impact of the 
      duration of antibiotics on clinical events in patients with Pseudomonas 
      aeruginosa ventilator-associated pneumonia (iDIAPASON) trial is a randomized, 
      open-labeled non-inferiority controlled trial, conducted in 34 French intensive 
      care units (ICUs), comparing two groups of patients with PA-VAP according to the 
      duration (8 days or 15 days) of effective antibiotic therapy against PA. The 
      primary outcome is a composite endpoint combining day 90 mortality and PA-VAP 
      recurrence rate during hospitalization in the ICU. Furthermore, durations of 
      mechanical ventilation and hospitalization, as well as number and types of 
      extrapulmonary infections or acquisition of MDR pathogens during the 
      hospitalization in the ICU will be recorded. Recurrence with predefined criteria 
      (clinical suspicion of VAP associated with a positive quantitative culture of a 
      respiratory sample) will be evaluated by two independent experts. DISCUSSION: 
      Demonstrating that an SD (8 days) versus LD (15 days) therapy strategy in PA-VAP 
      treatment is safe and not associated with an increased mortality or recurrence 
      rate could lead to a change in practices and guidelines in the management of 
      antibiotic therapy of this frequent ICU complication. This strategy could lead to 
      decreased antibiotic exposure during hospitalization in the ICU and in turn 
      reduce the acquisition and the spread of MDR pathogens. TRIAL REGISTRATION: 
      ClinicalTrials.gov: NCT02634411 . Registered on 19 November 2015.
FAU - Bougle, Adrien
AU  - Bougle A
AD  - Department of Anesthesiology and Critical Care, CHU La Pitie-Salpetriere, 
      Assistance Publique - Hopitaux de Paris (APHP), Paris, France. 
      adrien.bougle@aphp.fr.
FAU - Foucrier, Arnaud
AU  - Foucrier A
AD  - Department of Anesthesiology and Critical Care, Hopital Beaujon, APHP, Paris, 
      France.
FAU - Dupont, Herve
AU  - Dupont H
AD  - Department of Anesthesiology and Critical Care, CHU Amiens, Amiens, France.
AD  - Universite de Picardie Jules Verne, Amiens, France.
FAU - Montravers, Philippe
AU  - Montravers P
AD  - Department of Anesthesiology and Critical Care, CHU Bichat, APHP, Paris, France.
AD  - Universite Diderot, Paris, France.
FAU - Ouattara, Alexandre
AU  - Ouattara A
AD  - Department of Anesthesiology and Critical Care, Groupe Hospitalier Sud, Pessac, 
      Bordeaux, France.
AD  - Universite Bordeaux Segalen, Bordeaux, France.
FAU - Kalfon, Pierre
AU  - Kalfon P
AD  - Intensive Care Unit, Hopital Louis Pasteur, CH de Chartres, Chartres, France.
FAU - Squara, Pierre
AU  - Squara P
AD  - Intensive Care Unit, Clinique Ambroise Pare, Neuilly-sur-Seine, France.
FAU - Simon, Tabassome
AU  - Simon T
AD  - Unite de Recherche Clinique du GH HUEP (URC-Est), Hopital Saint-Antoine, APHP, 
      Paris, France.
AD  - UPMC - Sorbonne universites (Paris 6), Paris, France.
FAU - Amour, Julien
AU  - Amour J
AD  - Department of Anesthesiology and Critical Care, CHU La Pitie-Salpetriere, 
      Assistance Publique - Hopitaux de Paris (APHP), Paris, France.
AD  - UPMC - Sorbonne universites (Paris 6), Paris, France.
CN  - iDIAPASON study group
LA  - eng
SI  - ClinicalTrials.gov/NCT02634411
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170123
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Anti-Bacterial Agents)
SB  - IM
MH  - Anti-Bacterial Agents/*administration & dosage/adverse effects
MH  - Clinical Protocols
MH  - Cross Infection/diagnosis/*drug therapy/microbiology
MH  - Drug Administration Schedule
MH  - France
MH  - Humans
MH  - Pneumonia, Bacterial/diagnosis/*drug therapy/microbiology
MH  - Pneumonia, Ventilator-Associated/diagnosis/*drug therapy/microbiology
MH  - Pseudomonas Infections/diagnosis/*drug therapy/microbiology
MH  - Pseudomonas aeruginosa/*drug effects/isolation & purification/pathogenicity
MH  - Research Design
MH  - Respiration, Artificial/*adverse effects
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC5260072
OTO - NOTNLM
OT  - Antibiotic
OT  - Antibiotic resistance
OT  - Bacterial infection
OT  - Bacterial pneumonia
OT  - Intensive care
OT  - Nosocomial infections
OT  - Pseudomonas aeruginosa
OT  - Respiratory tract infection
OT  - Ventilator-associated pneumonia
EDAT- 2017/01/25 06:00
MHDA- 2018/03/06 06:00
PMCR- 2017/01/23
CRDT- 2017/01/25 06:00
PHST- 2016/05/24 00:00 [received]
PHST- 2017/01/02 00:00 [accepted]
PHST- 2017/01/25 06:00 [entrez]
PHST- 2017/01/25 06:00 [pubmed]
PHST- 2018/03/06 06:00 [medline]
PHST- 2017/01/23 00:00 [pmc-release]
AID - 10.1186/s13063-017-1780-3 [pii]
AID - 1780 [pii]
AID - 10.1186/s13063-017-1780-3 [doi]
PST - epublish
SO  - Trials. 2017 Jan 23;18(1):37. doi: 10.1186/s13063-017-1780-3.