Leishmaniasis, CutaneousPhase 3AIM-CLNCT06695143
Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia
A Phase 3 study testing Fusidic Acid in people with Leishmaniasis, Cutaneous, run by Institute of Tropical Medicine, Belgium at 2 sites in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- Fusidic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesEthiopia
- Study dates
- Apr 2025to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia2 sites
Arba Minch General Hospital
Arba Minch
Tamiru Degaga, Dr., +251 (0)9 117 047 67, drtamshib@gmail.com
Chencha Primary Hospital
Chencha
About this study
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:
Read more
- 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
- Being tested
- Fusidic Acid, Vehicle cream
- Keywords
- Cutaneous Leishmania, Complicated cutaneous leishmania
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fusidic AcidDrug
Fusidic acid 2% cream
Vehicle creamOther
Cetomacrogol cream
| Study group | Role | What they receive |
|---|---|---|
| Treatment - SoC + fusidic acid 2% cream | Experimental | 4 weeks SSG (SoC) with 2 weeks twice daily topical application of fusidic acid 2% cream Receives: Drug: Fusidic Acid |
| Vehicle - SoC + vehicle cream | Active comparator | 4 weeks SSG (SoC) with 2 weeks twice daily topical application of vehicle cream Receives: Other: Vehicle cream |
| Control - SoC | No intervention | 4 weeks SSG (SoC) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of index lesion at EoT
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 baseline assessment. Improvement will be measured for each lesion. At least the index lesion needs to be improved or cured for a patient to be considered substantially improved.
**Index lesion is defined as the largest lesion eligible for treatment.
Measured: 28 days
Secondary outcomes (12)
Arm 1 superiority to arm 3 - index lesion
To assess if Arm 1 is superior to Arm 3, using an ordinal (no improvement, minor improvement, substantial improvement, cure, relapse) and continuous (% re-epithelization/flattening) outcome measures for the index lesion at EoT and D42
Measured: 42 days
Arm 1 superiority to arm 3 - lesions eligible for treatment
To assess if Arm 1 is superior to Arm 3, using binary (at least substantial improvement), ordinal (no improvement, minor improvement, substantial improvement, cure, relapse) and continuous (% re-epithelization/flattening) outcome measures for all lesions eligible for treatment individually and combined at EoT and D42
Measured: 42 days
Proportion of participants that reach substiantial improvement - arm 1 vs arm 2
To compare the proportion of patients that reach at least substantial improvement of the index lesion, all lesions combined and individually at EoT and D42 between patients who received SoC with topical 2% fusidic acid (Arm 1, Treatment), and those who received SoC combined with topical vehicle cream (Arm 2, Vehicle)
Measured: 42 days
Proportion of participants that reach substiantial improvement - arm 2 vs arm 3
To compare the proportion of patients that reach at least substantial improvement of the index lesion, all lesions combined and individually at EoT and D42 between patients who received SoC combined with topical vehicle cream (Arm 2, Vehicle), and those who received SoC only (Arm 3, Control)
Measured: 42 days
Cycles needed for final cure
To compare the number of cycles needed to reach final cure per treatment arm
Measured: 180 days
Proportion of cured patients at day 180
To determine the proportion with 95% CI of patients that reach cure without relapsed or worsening at day 180 for the three treatment arms
Measured: 180 days
Quality of life - patient reported outcome
To compare change over time of patient-reported outcomes - the dermatological life quality index (DLQI) scores and global assessment - per treatment arm
Measured: 180 days
Safety and acceptability
To assess safety and acceptability of treatment arms
- Withdrawal from study intervention: proportion and 95% CI of patients withdrawn from intervention, per arm b) Adverse events: number and proportion of patients with adverse events, per arm c) Cumulative incidence of adverse events (AEs) related to the study drug d) Recommendability: acceptability and recommendability score (0-10) given by patients after treatment completion, per arm
Measured: 180 days
Stability microbial diversity
To determine the stability of microbial diversity in the healthy skin over time
Measured: 180 days
Increase microbial diversity
To assess the increase in microbial diversity indices within each trial arm at D14, EoT, D42 and M6 compared to D0.
Measured: 180 days
Correlation microbial diversity and substantial improvement
To determine whether increase in microbial diversity at EoT compared to D0 is correlated with substantial improvement of the index lesion and all lesions combined at EoT for the three trial arms
Measured: 180 days
Correlation microbial diversity and cure without relapse
To determine whether increase in microbial diversity at M6 compared to D0 is correlated with cure without relapse at M6, for the three trial arms
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study startApr 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmaniasis, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, Arba Minch University
- Responsible party
- Sponsor
- Investigators
- Johan Van Griensven, Prof, Principal investigator, Head of department of clinical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695143
- Sponsor's protocol ID
- AIM-CL
- Acronym
- AIM-CL
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia
- ClinicalTrials.gov ID
- NCT06695143
- Acronym / sponsor ID
- AIM-CL / AIM-CL
- Conditions
- Leishmaniasis, Cutaneous
- Keywords
- Cutaneous Leishmania, Complicated cutaneous leishmania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, Arba Minch University
- Study start
- Apr 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment - SoC + fusidic acid 2% cream | Experimental | Drug: Fusidic Acid4 weeks SSG (SoC) with 2 weeks twice daily topical application of fusidic acid 2% cream |
| Vehicle - SoC + vehicle cream | Active comparator | Other: Vehicle cream4 weeks SSG (SoC) with 2 weeks twice daily topical application of vehicle cream |
| Control - SoC | No intervention | –4 weeks SSG (SoC) only |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Clinical diagnosis of CL
- Need for systemic treatment (1 or more of these criteria)
- Age > 4 (minimum age to receive systemic treatment with SSG)
- At least one lesion eligible for treatment* (meeting all criteria below)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fusidic AcidFusidic acid 2% cream | Drug | Treatment - SoC + fusidic acid 2% cream |
| Vehicle creamCetomacrogol cream | Other | Vehicle - SoC + vehicle cream |
Primary outcome
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 baseline assessment. Improvement will be measured for each lesion. At least the index lesion needs to be improved or cured for a patient to be considered substantially improved. **Index lesion is defined as the largest lesion eligible for treatment.
12 secondary outcomes
Arm 1 superiority to arm 3 - index lesion
Time frame: 42 days
Arm 1 superiority to arm 3 - lesions eligible for treatment
Time frame: 42 days
Proportion of participants that reach substiantial improvement - arm 1 vs arm 2
Time frame: 42 days
Proportion of participants that reach substiantial improvement - arm 2 vs arm 3
Time frame: 42 days
Cycles needed for final cure
Time frame: 180 days
Proportion of cured patients at day 180
Time frame: 180 days
Quality of life - patient reported outcome
Time frame: 180 days
Safety and acceptability
Time frame: 180 days
Stability microbial diversity
Time frame: 180 days
Increase microbial diversity
Time frame: 180 days
Correlation microbial diversity and substantial improvement
Time frame: 180 days
Correlation microbial diversity and cure without relapse
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan Van Griensven, Prof principal investigator
Head of department of clinical sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fusidic Acid in people with Leishmaniasis, Cutaneous, run by Institute of Tropical Medicine, Belgium at 2 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaetan Van Aelst (+32(0)32476778, gvanaelst@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of index lesion at EoT (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.