Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)
Recruitment status was Recruiting
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Purpose
Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be performed by non invasive or semi invasive microbiological tools, semi invasive tools including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB). A microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's outcome.
These Two strategies have never been prospectivally evauated.
- Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB)for the care of patients admitted in intensive care for severe community acquired pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American thoracic guidelines
- Type of study randomized multicentric controlled open study
| Condition | Intervention |
|---|---|
|
Community Aquired Pneumonia |
Procedure: FOB protected distal microbiological samplings |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings |
| Study Start Date: | March 2006 |
Type of study randomized multicentric controlled open study
Number of patients: 200 patients (100 patients in each group)admitted in ICU for SCAP
- Number of center : 5
- Clinical strategies under evaluation :
- Group A: semi-invasive strategy: FOB within 24 hours after ICU admission
- Group B: non-invasive strategy: no FOB within 24 hours after ICU admission
- Evaluation criteria:
Main criteria: Changes in initial empirical antibiotic treatment according to microbiological results obtained in each group.
others
- FOB related complications
- Microbiological results
- Type of antibiotic treatment modifications
- ICU outcome and outcome at day 28
- Duration of antibiotic therapy and nimber of days without antibiotics at day 28 after inclusion
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
New radiological infiltrate SCAP clinical diagnosis admitted in ICU Admitted in hospital for less than 24 hours Aged 18 or older Signed informed consent
Exclusion Criteria:
Pregnancy Muribond patients Previuos hospitalisation within One month Neutropenia None HIV status
Contacts and Locations| Contact: HERER BERTRAND, MD | +33141878801 | formation-aducation@cardif.asso.fr |
| France | |
| Hotel dieu | Recruiting |
| Paris, France, 75004 | |
| Contact: Rabbat antoine, MD +33142348637 antoine.rabbat@htd.aphp.fr | |
| Principal Investigator: Rabbat antoine, MD | |
| Principal Investigator: | RABBAT Antoine, MD | APHP |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00308659 History of Changes |
| Other Study ID Numbers: | SCAP FOB, CNMR grant, cardiff |
| Study First Received: | March 28, 2006 |
| Last Updated: | March 28, 2006 |
| Health Authority: | France: CPPRB |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 21, 2013