Tuberculosis Clinical Trial
— FAST-TBOfficial title:
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation: a National Multicenter Randomized Clinical Trial
Verified date | March 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 (i.e. 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.
Status | Completed |
Enrollment | 204 |
Est. completion date | February 18, 2020 |
Est. primary completion date | July 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 84 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Bichat Claude Bernard Hospital | Paris | |
France | Bichat hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with treatment success at the end of TB treatment | TB treatment success (cure certain or probable cure) at the end of TB treatment cure certain: negative sputum cultures or negative sputum direct examination in a patient who has completed treatment and have never filled the definition of treatment failure. probable cure: clinical and radiological improvement of symptoms associated with tuberculosis in a patient who has completed treatment and have never filled the definition of treatment failure. completed treatment: patients who took more than 80% of prescribed treatment. clinical improvement: improvement in overall score of Teeter AND no weight loss radiological improvement: between baseline and end of treatment failure: if Positive sputum culture after 5 months of treatment, death during treatment whatever the cause, treatment interrupted for more than two months, decision of the clinician to change TB treatment because of the suspicion of failure after 5 months of TB treatment |
6 or 12 months after enrollment | |
Secondary | Proportion of patients with relapse | positive culture of respiratory sample after TB treatment and after having had negative cultures during treatment or decision by the clinician to restart treatment because of suspicion of relapse | within 12 months after the end of TB treatment | |
Secondary | Proportion of patients with failure | proportion of patients with treatment changes or discontinuations including the proportion of subjects stopping strategy and treatment assigned at randomization, and the delay between the stop and inclusion. Will not be considered modifications or discontinuations: adaptation of treatment on the results of susceptibility testing in the conventional arm (adaptations following the susceptibility in the PCR arm will therefore be considered as a modification). switching to bitherapy in the 2 arms. |
6 or 12 months after enrollment | |
Secondary | Capillary drug concentration, for each of the prescribed treatment in hair segments | measure of drug concentrations in hair segments, for each of the prescribed treatment, in order to estimate treatment observance and if drug hair concentrations are associated with therapy success or toxicity | at 2 and 6 months | |
Secondary | Incidence and nature of grade 3 or grade 4 adverse events related or not to TB treatments | comparison between the 2 arms of incidence and nature of grade 3 or grade 4 adverse events related or not to TB treatments | 6 months or at the latest 12 months after enrollment | |
Secondary | Direct medical costs associated with each strategy | comparison of direct medical costs induced by PCR strategy and by conventional strategy | within 18 or at the latest 12 months after enrolment |
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