Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
Status:
Recruiting
Trial end date:
2022-03-12
Target enrollment:
Participant gender:
Summary
The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to
treat with multiple drugs for 6 months, although patients often fail to adhere to the long
treatment, leading to poor clinical outcomes including drug resistance, which is expensive
and difficult to treat.
The TRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management Strategy)
comprising treatment for 2 months (8 weeks, extended to 12 weeks if inadequate clinical
response) with a regimen predicted to have enhanced sterilising activity ("boosted regimen")
and monitoring closely after treatment cessation. Those who relapse (predicted to be always
drug sensitive and likely to occur early) will be retreated with a standard 6 month regimen.
The trial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test the
hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the standard
management strategy in terms of longer-term outcomes (clinical status at 96 weeks). If
non-inferiority is demonstrated then the advantages/disadvantages of implementing the
strategy will be explored in secondary outcomes (from patient and programme perspective).
The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens
(180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens
include new drugs (licensed drugs, repurposed from other indications) and optimized doses of
standard drugs, selected based on consideration of maximal sterilising effect, absence of
drug-drug interactions, as well as safety and tolerability over a period of 2 months
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University College, London
Collaborators:
National University Hospital, Singapore Singapore Clinical Research Institute (SCRI)