Timing of Surgical Intervention in Buruli Ulcer Patients Treated With Antibiotics

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.

Conditions

• Mycobacterium Ulcerans Disease
• Buruli Ulcer

Interventions

PROCEDURE

surgical intervention on Buruli ulcer

Can the need for surgical intervention be avoided by delay of the decision on surgical intervention, comparing the need on surgical intervention from time points of week 8 and week 14 (number of weeks after start of antibiotic treatment with streptomycin/rifampicin).

Sponsors & Collaborators

• PNLUB, Ministère de la santé, Cotonou, République du Bénin.

  collaborator UNKNOWN

• Laboratoire de Référence des Mycobactéries

  collaborator OTHER_GOV

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• D Agossadou, MD · Program national lutte contre la lèpre et l'ulcère de Buruli, ministère de la santé, Hospital Lalo

• G Sopoh, MD PhD · Program national lutte contre la lèpre et l'ulcère de Buruli, Ministère de la Santé, Cotonou, Bénin, hospital Allada

• Tjip S van der Werf, MD PhD · UMCG - internal medicine/infectious diseases

• R OC Johnson, MD PhD · Cotonou, Bénin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Benin

Study Locations