Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205775486864 Date of Registration: 30/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title African leishmaniasis: From clinical research to access
Official scientific title ‘A PHASE II/ III, OPEN LABEL, MULTICENTRE, RANDOMISED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THERMOTHERAPY FOR THE TREATMENT OF UNCOMPLICATED CUTANEOUS LEISHMANIASIS CASES’
Brief summary describing the background and objectives of the trial Cutaneous Leishmaniasis (CL) is a major public health problem in poor tropical and sub-tropical communities around the world. In Ethiopia CL due to L. aethiopica is an unseen burden; 20,000 to 40,000 cases per year with 0ver 30 million at risk, has left thousands disfigured and stigmatized. Disproportionately affecting school- and active working age groups, its sequelae is beyond health; slows economic development due to loss of person-hours and academic performance at school. Data on treatment options could hardly be extrapolated across Leishmania species. No randomized trials on CL treatment due to L. aethiopica to date. Thus, the Ethiopian national leishmaniasis control program identified this gap and put trials on alternatives for the management of CL as one of the top priorities. Moreover, the parasitological factors related to its clinical manifestations, LCL, MCL and DCL, remain to be explored. Therefore, this study aims to determine the safety and efficacy of TT in uncomplicated CL lesions due to L. aethiopica and then, to determine its non-inferior safety and efficacy when compared to intralesional injections of sodium stibogluconate.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LeishAccess
Disease(s) or condition(s) being studied Infections and Infestations,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied Uncomplicated Cutaneous Leishmaniasis
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/06/2022
Actual trial start date 03/02/2023
Anticipated date of last follow up 03/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 326
Actual target sample size (number of participants) 182
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Local thermotherapy or heat therapy one session at the site of the lesion(s) at 50ºC for 30 seconds each application. The number of applications in a session depends on the size of the lesion, since the application of heat must cover the entire area of the lesion. The application of heat will be carried out in accordance with the standard operating procedure developed by the WHO, the WHO Eastern Mediterranean Region manual for CL case management. 1.Treatement Day: day1 Thermotherapy device (ThermoMed™), by ThermoMedTM Technologies, Inc., is a machine that generates a 6.78 mHz localized field of radiofrequency. The unit weighs 2.2 kg and measures 21 x 23 x 7 cm. It operates with batteries rechargeable on household current. The device has a dial on the main housing that allows for temperature selection. A wand with 2 electrodes is connected to the main housing by a thin wire. The device is approved by the FDA for CL local treatment use (FDA 510 K number K021117). It is also recommended as an alternative therapy for CL by WHO and the American Society of Tropical Medicine and Hygiene. TT is also indicated as topical options for CL by the national guideline; the guideline for the diagnosis, treatment and prevention of leishmaniasis in Ethiopia. 163
Control Group Sodium Stibogluconate Intralesional Sodium stibogluconate (SSG-IL): it is the standard care as per the national guideline for patients with uncomplicated CL lesions. Accordingly , SSG-IL is administered weekly for up to six weeks. Undiluted SSG is injected into the lesion until it blanches; about 0.2 to 0.5mL might be adequate for the first injection for small nodule or up to 2mL to infiltrate thickened areas of lesions up to 3cm large. Dose is 20 mg/(kg×d) for 20 days in the case of cutaneous disease. 1. Treatment days: Days 1, 7,14,21,28 and 35 Sodium Stibogluconate (SSG) is mainstay since 1940 antileishmanial drug that belongs to the pentavalent antimonial groups. Existing data about its mechanism of action suggest that it results in reduction in ATP and GTP synthesis which intern decreases macromolecular synthesis that eventually limit Leishmania viability. SSG is commercialized by Albert David Ltd., India and distributed by IDA Foundation, the Netherlands. It appears as a faintly straw-coloured fluid in a multi-dose brown opaque vial of 30 ml containing 100 mg pentavalent antimony in each ml (total 3 g). For CL, SSG is routinely administered intralesional weekly for four to six weeks, undiluted SSG is injected into the lesion until it blanches; about 0.2 to 0.5ml might be adequate for the first injection for small nodule or up to 2ml to infiltrate thickened areas of lesions up to 3cm large. When administrated systemically, SSG is given intravenously (slow over five minutes) or via IM at a daily dose of 20 mg/kg body weight. SSG is registered in Ethiopia. 163 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
· Males and females, aged ≥18 and ≤60 years old. · Patient with a confirmed diagnosis of CL in at least one lesion by at least one of the following methods: 1) Microscopic identification of amastigotes in stained lesion tissue, or 2) Demonstration of Leishmania by Polymerase Chain Reaction (PCR), or 3) Positive by NNN culture for promastigotes. Patient who has a lesion that satisfies the following criteria: - Lesion size less than or equal to 4 cm (longest diameter). - Not located on the ear, close to mucosal membranes, or in a location that in the opinion of the Principal Investigator (PI) is difficult to apply either intervention. - Patient with less than or equal to 4 CL lesions. - Duration of lesion less than 6 months by patient history. · Patient able to give written informed consent. In the opinion of the investigator, the patient is capable of understanding and complying with the protocol. •Females with a positive urine pregnancy test at screening and/or who do not agree to take contraception until end of treatment. •Prior topical treatment failure (including SSG-IL and/or cryotherapy) •Receiving a conventional treatment or traditional remedy against CL within 2 months of enrolment into the study •Any condition that prevents the patient from following the study treatment and/or the follow-up Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/05/2022 AHRI ALERT Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Jimma Road, Inside ALERT Compound Addis Ababa 1005 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/04/2022 National Research Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Addis Ababa Addis Ababa 23976 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/06/2021 ISCIII Research ethics Committee
Ethics Committee Address
Street address City Postal code Country
Instituto de Salud Carlos III Madrid 28220 Spain
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/09/2022 Ethiopian Food and Drug Authority
Ethics Committee Address
Street address City Postal code Country
Africa Avenue, near Wolosefer, Kirkos sub city Addis Ababa 5681 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome a. The proportion of adverse events by treatment group, as well as its frequency, severity, causality with each study drug and seriousness, b. The proportion of initial clinical/ late responders and final cure in each regimen (TT or IL-SSG) measured at Day 90/ Day 105 and Day 180 after onset of treatment respectively. At days : 90,105 and 180
Secondary Outcome a. Identify variation in isolates from different geographic and clinical types and associate with pathology and treatment response. b. Identify markers for potential point of care diagnosis/prognosis and epidemiological application. c. Assess the prevalence and impact of LRV on clinical phenotype and treatment outcomes. d. Document the quality of life from patients and health care provider perspective. At time of diagnosis or screening time or throughout the study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Boru Media Hospital South Wollo Dessie Ethiopia
ALERT Center Jimma road Addis Ababa 1005 Ethiopia
Dara Malo Center South Ethiopia Wacha Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 2509 AA The Hague The Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Armauer Hansen Research Institute Jimma Road, ALERT Compound Addis Ababa 1005 Ethiopia Research institute
COLLABORATORS
Name Street address City Postal code Country
Drugs for Neglected Diseases initiative 15, chemin Camille-Vidart, 1202 Geneva Geneva 1202 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Endalamaw Gadisa endalamaw.gadisa@ahri.gov.et +251911868827 Jimma Road, Inside ALERT Compound
City Postal code Country Position/Affiliation
Addis Ababa 1005 Ethiopia Lead Researcher and Director of MNTD
Role Name Email Phone Street address
Public Enquiries Adamu Bayissa adamu.bayissa@ahri.gov.et +251929041898 Jimma Road, Inside ALERT Compound
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia 1005 Ethiopia Clinical Coordinator
Role Name Email Phone Street address
Scientific Enquiries Adisu Asefa adiszthos13@gmail.com +251912464355 Jimma Road, Inside ALERT Compound
City Postal code Country Position/Affiliation
Addis Ababa 1005 Ethiopia Study coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Ethiopian MoH regularly disseminates key findings to the general public. This occurs through press releases and by including media reporters in data dissemination workshops with local leaders at the conclusion of each major activity, or sooner as important findings become available. Furthermore, the data will be shared with the international community and researchers through publication on internationally recognized peer-reviewed journals and presentations at international conference in the form of oral or poster presentations. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After the end of the study period . The data will be shared with the Ministry of Health and other stakeholders. It will also be shared with the international community and researchers through publication in internationally recognized peer-reviewed journals.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/08/2025 Result - 29/08/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information