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

Launched by INSTITUTE OF TROPICAL MEDICINE, BELGIUM · Nov 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat complicated cutaneous leishmaniasis (CL), a skin infection commonly found in Ethiopia. Researchers want to see if adding a topical cream called fusidic acid to the standard treatment, sodium stibogluconate (SSG), helps patients heal better. They will compare the results of three groups: one receiving SSG plus fusidic acid, another getting SSG with a placebo cream (which has no active ingredients), and a third group getting just SSG. The main goal is to find out if the cream helps improve the skin's health and leads to better recovery.

To participate in the trial, patients must be at least 4 years old, have a clinical diagnosis of complicated CL, and need systemic treatment due to specific criteria, such as having large lesions or multiple lesions. Participants will need to stay in the hospital for four weeks and will be monitored closely. The trial is not yet recruiting, but it aims to enroll 180 patients over two years, focusing on how restoring the balance of the skin's microbiome could offer a more effective and affordable treatment for CL.

Gender

ALL

Eligibility criteria

• Clinically suspected complicated CL patients visiting the study site meeting the following inclusion criteria and none of the exclusion criteria:
• Inclusion:
• • Clinical diagnosis of CL
• • Need for systemic treatment (1 or more of these criteria)
• • Mucosal involvement of lesion or at risk for mucosal involvement (\< 1 cm from the nose, eyes and vermillion border of the lips)
• • Lesion size \>4 cm
• • \>4 lesions
• • Lesions on joints or fingers
• • Lesions previously not responding to local treatment
• • Lesions unsuitable for local treatment (e.g., eyelids)
• • Lesions with signs of dissemination (satellite lesions, nodular lymphangitis, sporotrichoid pattern)
• • Age \> 4 (minimum age to receive systemic treatment with SSG)
• • At least one lesion eligible for treatment\* (meeting all criteria below)
• • lesion with surface change, including ulcerated, crusted and scaly lesions
• • distinguishable from other lesions (minimum 0.5 cm apart)
• • no mucosal involvement against which a topical agent would likely not be effective (e.g., lesions that are located too deep within the nasal passages or on the inner lip, where proper application is challenging and the ointment may be easily removed or not adequately absorbed)
• • Willing and able to provide informed consent. For participants under the age of 18, parental or caregiver consent is required. Additionally, assent must be obtained from adolescents aged 12 to 17
• • Willing to be hospitalized for 4 weeks
• Exclusion:
• • DCL patients
• • Only lesions not eligible for treatment\*
• • Currently on treatment or having received non-traditional antileishmanial treatment (cryotherapy, thermotherapy, sodium stibogluconate, meglumine antimoniate, paromomycin, pentamidine, AmBisome, miltefosine, non-liposomal amphotericin B) in the past 1 month
• • Currently on or having received topical antibiotic treatment for CL lesion(s) in the past 1 month
• • Currently on or having received systemic antibiotic treatment in general in the past 1 month
• • Currently in need for systemic antibiotics
• • Pregnant (positive pregnancy test at D0) or breastfeeding
• • Abnormal lab values
• • Hemoglobin \< 5.0g/100mL
• • Platelets \< 50 x 10\^9/L
• • White blood count \< 1 x 10\^9/L
• • ASAT/ALAT \> 3x upper normal range
• • Creatinine above the normal limit
• • Prolonged QTc interval or arrythmia on ECG or history of arrythmias
• • Known serious kidney or liver disease
• • Known allergies to one of the study components/medications
• • Serious adverse reaction to a previous SSG dose \*If a patient has multiple lesions, of which some are eligible for treatment and others are not, the patient can still be involved in the study. Only the eligible lesions will be subjected to treatment and outcome assessment.