Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02231229
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2014-07-03
Brief Title:
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis TB Treatment Initiation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis TB Treatment Initiation a National Multicenter Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST-TB
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 the results of drug susceptibility testing DST The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin RMP in case of primary resistance to INH Hence early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment i start with a 3-drug containing regimen ie INH RIF and PZA ii early enforcement of treatment when resistance is suspected pending in depth susceptibility testings
the duration of treatment is 6 months or 12 months
the duration of treatment is 6 months or 12 months
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 52 and 12 Based on these estimates French guidelines currently recommends 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 the results of drug susceptibility testing DST The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin RMP in case of primary resistance to INH Hence early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment i start with a 3-drug containing regimen ie INH RIF and PZA in patients with fully susceptible isolates currently 95 of cases ii early enforcement of treatment when resistance is suspected pending in depth susceptibility testings GenoType MTB DR plus sensitivity for RIF and INH resistance detection has been estimated at 100 and 83 respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB2013-A01406-39 | OTHER | FRENCH AUTHORITY | None |