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Trial record 12 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia (iDIAPASON) (iDIAPASON)

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ClinicalTrials.gov Identifier: NCT02634411
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : December 18, 2015
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units (Réseau RAISIN 2012). A short duration (8 days; SD) vs. long duration (15 days; LD) of antibiotic therapy has a comparable clinical efficacy with less antibiotic use and less multidrug-resistant pathogens (MDR) emergence. These results have led the American Thoracic Society to recommend SD therapy for VAP, with the exception of documented VAP of non-fermenting Gram negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA-VAP), due to the absence of studies focusing specifically on PA-VAP. Thus the beneficial effect of SD therapy in PA-VAP is still a matter of debate. In a small (n=127) subgroup analysis, a higher rate of recurrence with SD therapy (n=21, 32.8%) has been observed compared with LD therapy group (n=12, 19.0%). Unfortunately, the definition of recurrence was essentially based on microbiological rather than clinical data, and the higher rate of recurrence observed could rather reflect a higher rate of colonization more than a new infection.

Interestingly, a trend for a lower rate of mortality was also observed in the SD group (n=15, 23.4%) compared with the LD group (n=19, 30.2%), but this study was clearly underpowered to detect a difference of mortality between groups.

The two strategies were considered as not different, for the risk of mortality in a recent meta-analysis, performed on the very few available studies (n=2), that (OR = 1.33, 95% CI [0.33 to 5.26] for SD vs. LD strategies respectively). However, this conclusion remains questionable considering the large confidence interval of the risk and the power of these studies.

Primary objective and assessment criterion: To assess the non-inferiority of a short duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in P. aeruginosa ventilator-associated pneumonia (PA-VAP) on a composite end-point combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU.

Study Design :

Randomized, open-labeled non inferiority controlled trial 32 French Intensive Care Units participating to the study

Research period:

Total study duration: 27 months Inclusion period: 24 months Duration of participation for a patient: 90 days


Condition or disease Intervention/treatment Phase
Ventilator-Associated Pneumonia Drug: 8 days of effective antibiotic treatment Drug: 15 days of effective antibiotic treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia : a Randomized Controlled Study (iDIAPASON)
Study Start Date : June 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 8 days of effective antibiotic treatment
Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against PA of 8 days.
Drug: 8 days of effective antibiotic treatment

Antibiotics used for usual care in PA-VAP treatment : Penicillins, Cephalosporins, Monobactams, Carbapenems, Fluoroquinolones, Aminoglycosides (list not exhaustive).

Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against pseudomona aeruginosa of 8 days.


Sham Comparator: 15 days of effective antibiotic treatment
Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against PA of 15 days.
Drug: 15 days of effective antibiotic treatment

Antibiotics used for usual care in PA-VAP treatment : Penicillins, Cephalosporins, Monobactams, Carbapenems, Fluoroquinolones, Aminoglycosides (list not exhaustive).

Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against pseudomona aeruginosa of 15 days.





Primary Outcome Measures :
  1. A composite endpoint of morbi-mortality combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU (within 90 days). [ Time Frame: 90 days after effective antibiotherapy ]

    A composite endpoint combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU (within 90 days).

    Recurrence will be defined a posteriori by 3 independent experts with predefined criteria: clinical suspicion of VAP (≥ two criteria including: fever> 38.5 ° C, leukocytosis > 109/L or leukopenia < 4.108/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography) associated with a positive quantitative culture of a respiratory sample (bronchoalveolar lavage fluid (significant threshold ≥104 colony-forming units/mL) or plugged telescopic catheter (significant threshold ≥103 colony-forming units/mL) or quantitative endotracheal aspirate distal pulmonary secretion samples (significant threshold ≥106 colony-forming units/mL)).



Secondary Outcome Measures :
  1. Measure of mortality rate (%) in the ICU [ Time Frame: Day 30 and Day 90 after effective antibiotherapy ]
  2. Measure of morbidity in ICU by duration of mechanical ventilation (days) [ Time Frame: Day 30 and Day 90 after effective antibiotherapy ]
  3. Measure of morbidity in ICU by duration of hospitalization in ICU (days) [ Time Frame: Day 30 and Day 90 after effective antibiotherapy ]
  4. Acquisition of MDR during the hospitalization in the ICU. [ Time Frame: during stay in the ICU : up to 90 days ]
  5. Exposure to antibiotics during the hospitalization in the ICU (days) [ Time Frame: during stay in the ICU : up to 90 days ]
  6. Number of extrapulmonary infections during the hospitalization in the ICU [ Time Frame: during stay in the ICU : up to 90 days ]
  7. Type of extrapulmonary infections during the hospitalization in the ICU [ Time Frame: during stay in the ICU : up to 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Mechanical ventilation ≥ 48 hours
  • Documented Pseudomonas aeruginosa ventilator-associated pneumonia:

    • Clinical suspicion (≥ two criteria including: fever> 38.5°C, leukocytosis > 109/L or leukopenia < 4.108/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography).
    • Documented Pseudomonas aeruginosa positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, >104cfu/ml) or plugged telescopic catheter (significant threshold, >103cfu/ml) or quantitative endotracheal aspirate (significant threshold, >106cfu/ml).
  • Written informed consent
  • Patient affiliated to French social security

Exclusion Criteria:

  • Immunocompromised patients (HIV, immunosuppressive therapy, corticosteroids> 0.5 mg / kg per day for more than a month)
  • Patients receiving antibiotic therapy for extrapulmonary infection
  • Patients in whom a procedure of withdrawing life-sustaining treatment has been established
  • Pregnancy
  • Patients included in another interventional study
  • Chronic pulmonary colonization with Pseudomonas aeruginosa: patients with Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis, with a positive respiratory sample at infra threshold rate for Pseudomonas aeruginosa (ie<103 CFUs/mL for protected specimen brush or <106 CFUs/mL for tracheal aspirate), obtained in the absence of pneumonia or exacerbation during the 6 months before the ICU admission.
  • Patient under guardianship or curatorship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634411


Contacts
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Contact: Adrien Bouglé, MD (0)1 42 16 29 91 ext +33 adrien.bougle@aphp.fr
Contact: Julien Amour, MD PhD (0)1 42 16 56 41 ext +33 julien.amour@aphp.fr

Locations
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France
Anesthesiology and Critical Care Medicine Institut de Cardiologie, Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75571
Contact: Adrien Bouglé, MD    (0)1 42 16 29 91 ext +33    adrien.bougle@aphp.fr   
Contact: Julien Amour, MD PhD    (0)1 42 16 56 41 ext +33    julien.amour@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Adrien Bouglé, MD APHP

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02634411     History of Changes
Other Study ID Numbers: P 140923
AOM 14515 ( Other Identifier: AOM )
IDRCB n°: 2015-A00375-44 ( Other Identifier: IDRCP )
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Ventilator Associated
Pneumonia
Antibiotic treatment
Pseudomonas aeruginosa
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pneumonia, Ventilator-Associated
Pseudomonas Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Gram-Negative Bacterial Infections
Bacterial Infections