NCT02231229View on ClinicalTrials.gov

Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation

PHASE4CompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

July 23, 2014

Primary Completion Date

July 4, 2018

Study Completion Date

February 18, 2020

Conditions
Tuberculosis
Interventions
OTHER

PCR-based strategy

Treatment based on the results of detection of resistance to isoniazid and rifampicin using PCR (GenoType ® Mycobacterium Tuberculosis Drug Resistance (MTBDR)plus 2.0) in a smear positive patient with pulmonary tuberculosis: initiation of a 3 drug combination (isoniazid (H / INH); rifampicin (R /RIF); pyrazinamide (Z / PZA)) if no resistance is detected and treatment based on suspected resistance in case of INH and/or RIF resistant strain.

DRUG

conventional therapy

Initiation of a standard 4 drug combination (isoniazid (H / INH); rifampicin (R /RIF); pyrazinamide (Z / PZA); ethambutol (EMB or E)) until the results of DST are available.

Trial Locations (2)

75018

Bichat Claude Bernard Hospital, Paris

Bichat hospital, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT02231229 - Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation | Biotech Hunter | Biotech Hunter