Cutaneous LeishmaniasisNCT04699383
Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia
An observational study of Cutaneous Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
Trial summary
Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Sodium Stibogluconate with allopurinol
- How many people
- 105 participants
- Where
- 1 siteEthiopia
- Study dates
- 15 Feb 2021to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cLCL, MCL, or DCL who present during the study period, either referred from peripheral facilities or self-referred, and who receive systemic CL treatment using SSG and allopurinol will be invited to be included in the study consecutively. The decision whether or not to use SSG and Allopurinol in a patient is part of routine care.
Who may be able to join
- Clinically or microscopically confirmed diagnosis of MCL, DCL or complicated LCL
- Clinical routine care decision to initiate systemic CL treatment using SSG with allopurinol
- Willing and able to provide informed consent
Who cannot join
- Medical emergencies, underlying chronic conditions or other circumstances that make participation in this study medically or otherwise inadvisable
- Study sample collection only for Age 18 and above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Documentation of Patient Outcomes for the Combination Treatment of Sodium Stibogluconate and Allopurinol in Complicated Cutaneous Leishmaniasis in Ethiopia
Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated cutaneous leishmaniasis (CL) cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies.
This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.
Read the detailed description
Cutaneous Leishmaniasis (CL) in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are complicated localized cutaneous leishmaniasis (cLCL), mucocutaneous leishmaniasis (MCL), and diffuse cutaneous leishmaniasis (DCL). The clinical presentation of CL depends on various factors including parasite species, infection history and differences in the immune response. National guidelines recommend equally all drugs that are also used for visceral leishmaniasis treatment. Sodium stibogluconate (SSG) is one of these recommended medications. However, dermatologists in Ethiopia also use a combination of SSG and Allopurinol for treatment of complicated cutaneous leishmaniasis.
Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated CL cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies.
This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Sodium Stibogluconate with allopurinol
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Stibogluconate with allopurinolDrug
Routine administration of SSG/allopurinol combination treatment, from 1-5 cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment outcome at day 180 (proportion with cure, good response, poor response, no response and relapse)
cure defined as 100% flattening and/or reepithelization, good response 50-99% flattening and/or reepithelization, poor response 1-49% flattening and/or reepithelization, no response 0% flattening and/or reepithelization and relapse as worsening of existing lesion or appearance of new lesions
Measured: day 180
Secondary outcomes (5)
Patient reported outcomes using the dermatology life quality index (DLQI)
Mean difference in Dermatology life quality index (min 0, max 30) before treatment and at day 180
Measured: day 0 - day 180
Side-effects
Proportion of patients with side-effects and proportion of side-effects according to CTCAE severity grades
Measured: day 0 - day 180
Cycles to cure
Number of cycles needed to reach cure
Measured: day 0 - day 180
Factors associated with cure
To determine covariate-adjusted risk ratios for baseline and follow-up factors associated with cure after one cycle of treatment and at the end of cycle 5
Measured: day 30, day 180
Treatment outcome at day 30 (proportion with cure, good response, poor response, and no response )
cure defined as 100% flattening and/or reepithelization, good response 50-99% flattening and/or reepithelization, poor response 1-49% flattening and/or reepithelization, no response 0% flattening and/or reepithelization
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start15 Feb 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LeishmaniasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Wollo University, Boru Meda Hospital, University of Gondar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699383
- Sponsor's protocol ID
- 1361/20
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2020
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Henten S, Bialfew F, Hassen S, Tilahun F, van Griensven J, Abdela SG. Treatment of Cutaneous Leishmaniasis with Sodium Stibogluconate and Allopurinol in a Routine Setting in Ethiopia: Clinical and Patient-Reported Outcomes and Operational Challenges. Trop Med Infect Dis. 2023 Aug 14;8(8):414. doi: 10.3390/tropicalmed8080414.
PubMed 37624352
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of Patient Outcomes for the Combination Treatment of Sodium Stibogluconate and Allopurinol in Complicated Cutaneous Leishmaniasis in Ethiopia
- ClinicalTrials.gov ID
- NCT04699383
- Acronym / sponsor ID
- 1361/20
- Conditions
- Cutaneous Leishmaniasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Wollo University, Boru Meda Hospital, University of Gondar
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 7 Jan 2021 (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.
Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated cutaneous leishmaniasis (CL) cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies.
This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.
Detailed description
Cutaneous Leishmaniasis (CL) in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are complicated localized cutaneous leishmaniasis (cLCL), mucocutaneous leishmaniasis (MCL), and diffuse cutaneous leishmaniasis (DCL). The clinical presentation of CL depends on various factors including parasite species, infection history and differences in the immune response. National guidelines recommend equally all drugs that are also used for visceral leishmaniasis treatment. Sodium stibogluconate (SSG) is one of these recommended medications. However, dermatologists in Ethiopia also use a combination of SSG and Allopurinol for treatment of complicated cutaneous leishmaniasis.
Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated CL cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies.
This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cLCL, MCL, or DCL who present during the study period, either referred from peripheral facilities or self-referred, and who receive systemic CL treatment using SSG and allopurinol will be invited to be included in the study consecutively. The decision whether or not to use SSG and Allopurinol in a patient is part of routine care.
Key inclusion criteria (3 listed)
- Clinically or microscopically confirmed diagnosis of MCL, DCL or complicated LCL
- Clinical routine care decision to initiate systemic CL treatment using SSG with allopurinol
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Medical emergencies, underlying chronic conditions or other circumstances that make participation in this study medically or otherwise inadvisable
- Study sample collection only for Age 18 and above
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 |
|---|---|---|
| Sodium Stibogluconate with allopurinolRoutine administration of SSG/allopurinol combination treatment, from 1-5 cycles | Drug | – |
Primary outcome
Treatment outcome at day 180 (proportion with cure, good response, poor response, no response and relapse)
Time frame: day 180
cure defined as 100% flattening and/or reepithelization, good response 50-99% flattening and/or reepithelization, poor response 1-49% flattening and/or reepithelization, no response 0% flattening and/or reepithelization and relapse as worsening of existing lesion or appearance of new lesions
5 secondary outcomes
Patient reported outcomes using the dermatology life quality index (DLQI)
Time frame: day 0 - day 180
Side-effects
Time frame: day 0 - day 180
Cycles to cure
Time frame: day 0 - day 180
Factors associated with cure
Time frame: day 30, day 180
Treatment outcome at day 30 (proportion with cure, good response, poor response, and no response )
Time frame: day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 37624352van Henten S, Bialfew F, Hassen S, Tilahun F, van Griensven J, Abdela SG. Treatment of Cutaneous Leishmaniasis with Sodium Stibogluconate and Allopurinol in a Routine Setting in Ethiopia: Clinical and Patient-Reported Outcomes and Operational Challenges. Trop Med Infect Dis. 2023 Aug 14;8(8):414. doi: 10.3390/tropicalmed8080414.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment outcome at day 180 (proportion with cure, good response, poor response, no response and relapse) (time frame: day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699383, which also lists 1 linked publication.
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 18 Mar 2024.