Status:
COMPLETED
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Tuberculosis
Eligibility:
All Genders
18-84 years
Phase:
PHASE4
Brief Summary
French guidelines currently recommend to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending t...
Detailed Description
The impact of rapid detection of resistance with PCR has been poorly evaluated in low-endemic countries. In France, primary resistance to isoniazid and rifampicin were estimated at, respectively, 5.2%...
Eligibility Criteria
Inclusion
- Adult patients
- with active pulmonary tuberculosis (TB) and positive respiratory samples on microscopic examination for acid-fast bacilli (AFB+,) who are eligible for a standard TB treatment with a 4 drug combination
- PCR (Genotype MTBDR Plus v2.0, Hain Lifescience) result available within the first 7 days of tuberculosis treatment.
- who are seeking care in France (metropolitan or overseas) and accept a follow-up of 18 to 24 months after inclusion.
- who have had a prior clinical examination
Exclusion
- Refusal to participate in the study
- Prior history of TB treatment
- For women of child bearing age, pregnancy, willing to become pregnant or breastfeeding
- Patient without healthcare insurance (French social security)
- Patient participating in another clinical trial
- Any condition that might compromise, in the investigator's opinion, patient's compliance with the protocol.
- Results of cultures available at enrollment
- No HIV testing available within the last 3 months prior to inclusion in the study.
Key Trial Info
Start Date :
July 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2020
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02231229
Start Date
July 23 2014
End Date
February 18 2020
Last Update
March 18 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Bichat Claude Bernard Hospital
Paris, France, 75018
2
Bichat hospital
Paris, France, 75018