Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
Brief 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


Options:
A: Arm Label: evaluation surgical intervention at week 8; Type: OTHER; Interventions: Procedure: surgical intervention on Buruli ulcer | Arm Label: evaluation surgical intervention at week 14; Type: OTHER; Interventions: Procedure: surgical intervention on Buruli ulcer | Intervention Type: PROCEDURE; Name: surgical intervention on Buruli ulcer; Assigned to Arm(s): evaluation surgical intervention at week 14, evaluation surgical intervention at week 8
B: Arm Label: SR8; Type: ACTIVE_COMPARATOR; Interventions: Drug: Streptomycin intramuscular injection | Arm Label: CR8; Type: EXPERIMENTAL; Interventions: Drug: Clarithromycin Extended Release | Intervention Type: DRUG; Name: Clarithromycin Extended Release; Assigned to Arm(s): CR8 | Intervention Type: DRUG; Name: Streptomycin intramuscular injection; Assigned to Arm(s): SR8
C: Arm Label: SR4/CR4; Type: EXPERIMENTAL; Interventions: Drug: SR4 - switch to CR4 | Arm Label: SR8; Type: ACTIVE_COMPARATOR; Interventions: Drug: SR4 - switch to CR4 | Intervention Type: DRUG; Name: SR4 - switch to CR4; Assigned to Arm(s): SR4/CR4, SR8
D: Arm Label: Standard TB Management Strategy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rifampicin, Drug: Isoniazid, Drug: Pyrazinamide, Drug: Ethambutol | Arm Label: TRUNCATE-TB Management Strategy using Regimen B; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid, Drug: Pyrazinamide, Drug: Ethambutol, Drug: Linezolid, Drug: Rifampicin | Arm Label: TRUNCATE-TB Management Strategy using Regimen C; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid, Drug: Pyrazinamide, Drug: Ethambutol, Drug: Clofazimine, Drug: Rifampicin | Arm Label: TRUNCATE-TB Management Strategy using Regimen D; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid, Drug: Pyrazinamide, Drug: Linezolid, Drug: Rifapentine, Drug: Levofloxacin | Arm Label: TRUNCATE-TB Management Strategy using Regimen E; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid, Drug: Pyrazinamide, Drug: Ethambutol, Drug: Linezolid, Drug: Bedaquiline | Intervention Type: DRUG; Name: Rifampicin; Assigned to Arm(s): Standard TB Management Strategy | Intervention Type: DRUG; Name: Isoniazid; Assigned to Arm(s): Standard TB Management Strategy, TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C, TRUNCATE-TB Management Strategy using Regimen D, TRUNCATE-TB Management Strategy using Regimen E | Intervention Type: DRUG; Name: Pyrazinamide; Assigned to Arm(s): Standard TB Management Strategy, TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C, TRUNCATE-TB Management Strategy using Regimen D, TRUNCATE-TB Management Strategy using Regimen E | Intervention Type: DRUG; Name: Ethambutol; Assigned to Arm(s): Standard TB Management Strategy, TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C, TRUNCATE-TB Management Strategy using Regimen E | Intervention Type: DRUG; Name: Linezolid; Assigned to Arm(s): TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen D, TRUNCATE-TB Management Strategy using Regimen E | Intervention Type: DRUG; Name: Clofazimine; Assigned to Arm(s): TRUNCATE-TB Management Strategy using Regimen C | Intervention Type: DRUG; Name: Rifapentine; Assigned to Arm(s): TRUNCATE-TB Management Strategy using Regimen D | Intervention Type: DRUG; Name: Levofloxacin; Assigned to Arm(s): TRUNCATE-TB Management Strategy using Regimen D | Intervention Type: DRUG; Name: Bedaquiline; Assigned to Arm(s): TRUNCATE-TB Management Strategy using Regimen E | Intervention Type: DRUG; Name: Rifampicin; Assigned to Arm(s): TRUNCATE-TB Management Strategy using Regimen B, TRUNCATE-TB Management Strategy using Regimen C

Answer: D