Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multiple Arm, Multiple Stage, Phase 2, OL, Randomized, Controlled Trial to Evaluate 4 Treatment Regimens of SQ109, Increased Doses of Rifampicin, and Moxifloxacin in Adults With Newly Diagnosed, Smear-positive Pulmonary Tuberculosis
Brief Summary: This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in patients with smear positive, pulmonary tuberculosis (TB). Patients will be randomly allocated to the control or one of the four experimental regimens in the ratio 2:1:1:1:1. Experimental regimens will be given for 12 weeks. Thereafter, participants in the experimental arms will receive continuation phase treatment for 14 weeks containing standard-dose rifampicin and isoniazid. All participants will receive 25 mg of vitamin B6 (pyridoxine) with every dose of INH to prevent INH-related neuropathy. Interim analyses will be conducted during the trial for efficacy, with the aim of identifying experimental arms that perform below a pre-specified efficacy threshold; these arms will then be stopped from further recruitment.

Following the first scheduled interim analysis on March 3rd, the Trial Steering Committee (TSC) followed a recommendation of the independent data monitoring committee (IDMC) and has stopped the enrolment into two of the arms in the MAMS-TB trial: HRZQ and HR20ZQ, based on these arms not meeting the pre-specified gain in efficacy over control. Importantly, there was no safety concern that prompted stopping recruitment to these arms. They recommended that recruitment to arm 2 (HRZQ) and 3 (HR20ZQ) be terminated as there was insufficient evidence that these regimens could shorten treatment. Importantly, there was no evidence that either arm was inferior to standard treatment (the control arm) with regards to efficacy. There was, however, sufficient evidence that the other intervention arms HR35ZE and HR20ZM could shorten treatment to continue enrolling patients.


Options:
A: Arm Label: Cohort 1; Type: EXPERIMENTAL; Interventions: Drug: PNU-100480, Drug: Placebo | Arm Label: Cohort 2; Type: EXPERIMENTAL; Interventions: Drug: PNU-100480, Drug: Placebo | Arm Label: Cohort 3; Type: EXPERIMENTAL; Interventions: Drug: PNU-100480, Drug: Placebo | Arm Label: Cohort 4; Type: EXPERIMENTAL; Interventions: Drug: PNU-100480, Drug: Placebo | Arm Label: Cohort 5; Type: EXPERIMENTAL; Interventions: Drug: PNU-100480, Drug: Placebo | Arm Label: Cohort 6 (optional); Type: EXPERIMENTAL; Interventions: Drug: PNU-100480, Drug: Placebo | Arm Label: Linezolid Cohort; Type: EXPERIMENTAL; Interventions: Drug: Linezolid | Intervention Type: DRUG; Name: PNU-100480; Assigned to Arm(s): Cohort 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 1 | Intervention Type: DRUG; Name: PNU-100480; Assigned to Arm(s): Cohort 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 2 | Intervention Type: DRUG; Name: PNU-100480; Assigned to Arm(s): Cohort 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 3 | Intervention Type: DRUG; Name: PNU-100480; Assigned to Arm(s): Cohort 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 4 | Intervention Type: DRUG; Name: PNU-100480; Assigned to Arm(s): Cohort 5 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 5 | Intervention Type: DRUG; Name: PNU-100480; Assigned to Arm(s): Cohort 6 (optional) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 6 (optional) | Intervention Type: DRUG; Name: Linezolid; Assigned to Arm(s): Linezolid Cohort
B: Arm Label: TMC207 Stage 1; Type: EXPERIMENTAL; Interventions: Drug: TMC207, Drug: Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) | Arm Label: Placebo Stage 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) | Arm Label: TMC207 Stage 2; Type: EXPERIMENTAL; Interventions: Drug: TMC207, Drug: Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) | Arm Label: Placebo Stage 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) | Intervention Type: DRUG; Name: TMC207; Assigned to Arm(s): TMC207 Stage 1, TMC207 Stage 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Stage 1, Placebo Stage 2 | Intervention Type: DRUG; Name: Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis); Assigned to Arm(s): Placebo Stage 1, Placebo Stage 2, TMC207 Stage 1, TMC207 Stage 2
C: Arm Label: Arm 1 (R35); Type: EXPERIMENTAL; Interventions: Drug: Rifampicin, Drug: isoniazid, Drug: pyrazinamide, Drug: ethambutol, Dietary Supplement: pyridoxine | Arm Label: HRZQ; Type: EXPERIMENTAL; Interventions: Drug: SQ109, Drug: Rifampicin, Drug: isoniazid, Drug: pyrazinamide, Dietary Supplement: pyridoxine | Arm Label: HR20ZQ; Type: EXPERIMENTAL; Interventions: Drug: SQ109, Drug: Rifampicin, Drug: isoniazid, Drug: pyrazinamide, Dietary Supplement: pyridoxine | Arm Label: HR20ZM; Type: EXPERIMENTAL; Interventions: Drug: Rifampicin, Drug: isoniazid, Drug: pyrazinamide, Dietary Supplement: pyridoxine | Arm Label: HRZE; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rifampicin, Drug: Moxifloxacin, Drug: isoniazid, Drug: pyrazinamide, Drug: ethambutol, Dietary Supplement: pyridoxine | Intervention Type: DRUG; Name: SQ109; Assigned to Arm(s): HR20ZQ, HRZQ | Intervention Type: DRUG; Name: Rifampicin; Assigned to Arm(s): Arm 1 (R35), HR20ZM, HR20ZQ, HRZE, HRZQ | Intervention Type: DRUG; Name: Moxifloxacin; Assigned to Arm(s): HRZE | Intervention Type: DRUG; Name: isoniazid; Assigned to Arm(s): Arm 1 (R35), HR20ZM, HR20ZQ, HRZE, HRZQ | Intervention Type: DRUG; Name: pyrazinamide; Assigned to Arm(s): Arm 1 (R35), HR20ZM, HR20ZQ, HRZE, HRZQ | Intervention Type: DRUG; Name: ethambutol; Assigned to Arm(s): Arm 1 (R35), HRZE | Intervention Type: DIETARY_SUPPLEMENT; Name: pyridoxine; Assigned to Arm(s): Arm 1 (R35), HR20ZM, HR20ZQ, HRZE, HRZQ
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol | Intervention Type: DRUG; Name: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Isoniazid, Rifampin, Pyrazinamide, Ethambutol; Assigned to Arm(s): 2

Answer: C