NCT06695143: AIM-CL

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

Not yet recruiting Phase 3 Last updated 16 November 2024

What this trial tests

Phase 3 trial testing Fusidic Acid in Leishmaniasis, Cutaneous in 180 participants. Not yet recruiting.

Timeline

1 April 2025

Primary endpoint
1 March 2027

1 April 2027

Quick facts

Lead sponsor	Institute of Tropical Medicine, Belgium
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	1 April 2025
Primary completion	1 March 2027
Estimated completion	1 April 2027
Sites	2 locations across Ethiopia

Drugs / interventions tested

• Fusidic Acid (FUSIDIC ACID) — full drug profile →
• Vehicle cream — full drug profile →

Conditions studied

• Leishmaniasis, Cutaneous — all drugs for Leishmaniasis, Cutaneous →

Sponsor

Institute of Tropical Medicine, Belgium

Who can join

4 and older, any sex, with Leishmaniasis, Cutaneous. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Improvement of index lesion at EoT
  Time frame: 28 days
  To assess if 4 weeks SoC with 2 weeks application of 2% fusidic acid twice per day (Arm 1, Treatment) is superior to 4 weeks SoC only (Arm 3, Control) for complicated CL patients, in terms of reaching at least substantial improvement\* of the index lesion\*\* at the end of treatment (EoT). \*Substantial improvement is defined as \>50% flattening and \>50% re-epithelization compared to the baselin

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.