Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Timing of the Decision on Surgical Intervention for Buruli Ulcer Patients Treated With Rifampicin/Streptomycin
Brief Summary: SUMMARY

Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic in West Africa. It often leads to functional limitations. Treatment was by extensive surgery, until in 2005 gradually antibiotic treatment for eight weeks with rifampicin and streptomycin was added. Observation of Buruli ulcer lesions of limited size during antibiotic treatment showed that during treatment there is a paradoxical increase of the lesion, with a decrease of the lesion after week 14. Current WHO protocols advise to decide whether surgery is needed four weeks after the start of antibiotics. This might be too early in the healing process. The investigators hypothesize that delay in surgery is safe, and that it results in a reduction of the number of surgical interventions.

Objectives:

Primary Objective of this study is to compare the need for surgical treatment in standard timing of surgery at the end of eight weeks antimicrobial treatment with a policy to postpone surgical treatment until week 14.

Secondary Objectives are to study whether postponing surgery leads to less extensive surgery and a change in frequency of functional limitations;

Study design:

Patients will be randomized for surgery at week 8 after start of antibiotic treatment and week 14 after start of treatment. Reasons for treating doctors to decide to intervene with surgery will be according to current clinical practice and will be clearly defined in this protocol. Standard care of eight weeks of rifampicin and streptomycin will be given. All patients will be followed and lesional size using acetate sheet recordings will be used during follow-up.

Study population: Patients with a clinical picture of Buruli ulcer disease confirmed by diagnostic tests in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin. Patients who are pregnant, have a contraindication for general anaesthesia and children below three years old will be excluded. 130 Patients in each treatment arm will be included to detect a difference in percentage of patients needing surgery of 20 percent.

Main study parameters/endpoints: Primary outcome measure is the number of patients healed without surgery. Secondary outcome measures are the extent of surgery by measurement of lesional size, functional limitations after the end of treatment and one year after the start of treatment and the duration of admission.


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: 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: 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
D: 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

Answer: D