Evaluation of High Dose Rifampicin and Dialkylcarbamoyl chloride (DACC)-coated dressings to improve outcomes in Mycobacterium ulcerans disease

Conditions

Skin and Connective Tissue Diseases

Yaw Ampem Amoako, Abigail Agbanyo, Jacob Novignon, Lucy Owusu, Joseph Tuffour et al. (16 authors)

NIHR Open Research2023-02-241 citations

10.3310/nihropenres.13332.2

Buruli-RifDACC: Evaluation of the efficacy and cost-effectiveness of high-dose versus standard-dose rifampicin on outcomes in Mycobacterium ulcerans disease, a protocol for a randomised controlled trial in Ghana

Yaw Ampem Amoako, Abigail Agbanyo, Jacob Novignon, Lucy Owusu, Joseph Tuffour et al. (16 authors)

NIHR Open Research2022-11-293 citations

10.3310/nihropenres.13332.1

Interventions

Standard dose Rifampicin Clarithromycin and DACC dressing

High Dose Rifampicin and DACC Dressing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: i. Age between 5 and 80 years old ii. Have a nodule, plaque or ulcer, with or without associated oedema. iii. Lesion that has tested positive for M. ulcerans by Polymerase Chain Reaction (PCR) for IS2404 iv. Participant or parent/guardian able to give informed consent. v. Able and willing to follow the protocol requirements

Exclusion criteria

Exclusion criteria: i. Current participation in any interventional study at the time of randomisation ii. Known allergy to any component of DACC dressing iii. Known contraindication to either Rifampicin or clarithromycin

Design outcomes

Primary

Measure	Time frame
Time to clearance of viable mycobacterium from wounds	—

Secondary

Measure	Time frame
• Time to healing of the BU wound between groups • Proportion of patients with paradoxical reaction in each treatment arm • Proportion of patients with recurrence of BU in each treatment arm by 12 months • Proportion of patients with clinical evidence of a secondary infection during their BU treatment • The incremental financial and economic costs per patient of the high dose Rifampicin vs standard dose Rifampicin (from household and provider perspectives)	—

Measure

Time frame

• Time to healing of the BU wound between groups • Proportion of patients with paradoxical reaction in each treatment arm • Proportion of patients with recurrence of BU in each treatment arm by 12 months • Proportion of patients with clinical evidence of a secondary infection during their BU treatment • The incremental financial and economic costs per patient of the high dose Rifampicin vs standard dose Rifampicin (from household and provider perspectives)

—

Countries

Ghana

Contacts

Public ContactYaw Amoako

Study Clinician

yamoako2002@gmail.com+233244858075

Outcome results

None listed