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Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia

NCT06695143 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-11-19

No results posted yet for this study

Summary

This clinical trial aims to evaluate the effectiveness of combining the standard treatment for complicated cutaneous leishmaniasis (CL), sodium stibogluconate (SSG), with either topical fusidic acid 2% cream or a vehicle cream without active ingredient. The goal is to assess whether this combination improves treatment outcomes by restoring the balance of the skin microbiome (dysbiosis) in patients with severe CL, a condition common in Ethiopia.

The study will compare three treatment groups:

* Fusidic Acid Group: SSG plus topical fusidic acid for 2 weeks.
* Vehicle Cream Group: SSG plus topical vehicle cream for 2 weeks.
* Control Group: SSG only, with no topical treatment.

The primary objective is to determine if the addition of fusidic acid improves treatment outcomes compared to SSG alone, as measured by substantial improvement in the index lesion at the end of treatment (EoT).

A total of 180 patients will be enrolled at two hospitals in Ethiopia. The trial will run for 24 months, with a focus on understanding how restoring the skin microbiome can improve CL treatment outcomes and potentially provide a low-cost, accessible treatment strategy for CL patients.

Conditions

  • Leishmaniasis, Cutaneous

Interventions

DRUG

Fusidic Acid

Fusidic acid 2% cream

OTHER

Vehicle cream

Cetomacrogol cream

Sponsors & Collaborators

  • Armauer Hansen Research Institute (AHRI), Ethiopia

    collaborator UNKNOWN

  • Arba Minch University

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Johan Van Griensven, Prof · Head of department of clinical sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-03-31
Completion
2027-04-30

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06695143 on ClinicalTrials.gov