Community Aquired PneumoniaNCT00308659
Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)
A study testing FOB protected distal microbiological samplings in people with Community Aquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Aquired Pneumonia
- What is being tested?
- FOB protected distal microbiological samplings
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Mar 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New radiological infiltrate SCAP clinical diagnosis admitted in ICU Admitted in hospital for less than 24 hours Aged 18 or older Signed informed consent
Who cannot join
- Pregnancy Muribond patients Previuos hospitalisation within One month Neutropenia None HIV status
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hotel dieu
Paris, 75004
Rabbat antoine, MD, +33142348637, antoine.rabbat@htd.aphp.fr
Rabbat antoine, MD
About this study
Official title: Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings
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
Read the detailed description
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
- Conditions
- Community Aquired Pneumonia
- Being tested
- FOB protected distal microbiological samplings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOB protected distal microbiological samplingsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Aquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- RABBAT Antoine, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308659
- Sponsor's protocol ID
- SCAP FOB
- Other IDs
- CNMR grant, cardiff
- Status last verified
- Mar 2006
- First submitted
- 28 Mar 2006
- Last updated
- 30 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings
- ClinicalTrials.gov ID
- NCT00308659
- Acronym / sponsor ID
- SCAP FOB
- Conditions
- Community Aquired Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2006
- First posted
- 30 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New radiological infiltrate SCAP clinical diagnosis admitted in ICU Admitted in hospital for less than 24 hours Aged 18 or older Signed informed consent
Key exclusion criteria (1 listed)
- Pregnancy Muribond patients Previuos hospitalisation within One month Neutropenia None HIV status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOB protected distal microbiological samplings | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RABBAT Antoine, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOB protected distal microbiological samplings in people with Community Aquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HERER BERTRAND, MD (+33141878801, formation-aducation@cardif.asso.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2006.