Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Controlled Trial Comparing Efficacy of 8 Weeks Treatment With Clarithromycin and Rifampicin Versus Streptomycin and Rifampicin for Buruli Ulcer (M. Ulcerans Infection)
Brief Summary: This is a WHO-sponsored trial.

Combination therapy with streptomycin and rifampicin has been the standard antibiotic treatment for M. ulcerans infection since 2004. In March 2010, a WHO Technical Advisory Group recommended that a trial be carried out to develop a fully oral treatment for the disease. Although the current treatment is effective, injection with streptomycin is a problem. Several small observational studies (published and unpublished) have shown that a fully oral treatment is promising.

This WHO sponsored study will be a randomized, controlled open label non-inferiority phase II/III, multi-centre trial (1 centre in Benin and 4 centres in Ghana), with two parallel treatment groups. The ultimate goal is to search for an effective alternative treatment to the current standard WHO-recommended therapy for all forms of Buruli ulcer, which includes injections of streptomycin with inherent logistic, operational and safety disadvantages.

Financial and material support:

1. American Leprosy Missions, USA
2. Raoul Follereau Foundation, France
3. MAP International, USA
4. Sanofi, France
5. 7th Framework Programme of the European Union: BuruliVac project (241500)
6. Aranz Medical Limited, New Zealand


Options:
A: 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
B: 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
C: 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
D: 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

Answer: D