New treatments for PKDL (Eastern Africa)
New treatments for PKDL (Eastern Africa)
Determine the safety and efficacy of two treatment regimens for patients with PKDL in Eastern Africa
current phase of drug development
updated 13 Dec 2024
Post-kala-azar dermal leishmaniasis (PKDL) is a non-lethal complication of visceral leishmaniasis that, in the Eastern Africa region, usually develops a few months after a person completes visceral leishmaniasis treatment. It affects mainly children. The characteristic skin rash often appears on the face and spreads to other parts of the body. In some cases, PKDL may self-heal, but in others the disease may persist for a very long time, and symptoms can progress to become severely disfiguring and stigmatizing. Better options are needed to improve upon existing old antimonial-based treatments, which are expensive and lengthy, with complex administration and potentially life-threatening side effects, including cardiotoxicity.
DNDi is prioritizing early treatment of PKDL in Eastern Africa given the role of PKDL as a reservoir for visceral leishmaniasis infection, as demonstrated in studies in Bangladesh and India. Early treatment of PKDL patients is a critical component of visceral leishmaniasis public health and elimination strategies, and forms part of the Strategic framework for the elimination of visceral leishmaniasis as a public health problem in eastern Africa 2023–2030 – with the goal of detecting, treating, and managing all cases of PKDL.
DNDi’s Phase II study in Sudan has demonstrated the suitability of two combination treatments – miltefosine and paromomycin (MF+PM) and liposomal amphotericin B and miltefosine (LAmB+MF) – as safe, effective, shorter treatments for patients with PKDL.
Find out more about our project developing new treatments for PKDL in South Asia.
Project updates
2023
The Phase II clinical trial in Sudan was completed, demonstrating the suitability of two combination treatments: miltefosine and paromomycin (MF+PM), and liposomal amphotericin B and miltefosine (LAmB+MF) as safe, effective, shorter treatments for PKDL. Findings from the Phase II trial in Sudan were published in November 2023. It is expected that these alternative therapies will be recommended for patients with PKDL in Eastern Africa.
2022
The final clinical study report for the Phase II PKDL trial in Sudan was released in January 2022 and shared with the Sudanese regulatory agency and ethical approval committees. Discussions regarding potential changes to PKDL treatment guidelines are ongoing with the Ministry of Health. The study manuscript is expected to be published in the second quarter of 2023.
2021
The Phase II study in Sudan testing both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM), completed enrolment and follow-up of all 110 patients in May 2021. Final study results are expected in the first quarter of 2022.
2020
DNDi’s Phase II study in Sudan testing both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM), completed enrolment of 110 patients in May 2020. Patient follow-up will continue through the first half of 2021; results are expected by the end of 2021.
2019
A Phase II study to test both liposomal amphotericin B in combination with miltefosine, and paromomycin in combination with miltefosine began in Dooka, Sudan in 2018 and had enrolled 73 patients by January 2020. Results are expected by 2021.
Work continues at University of Gedaref in Sudan to establish a sandfly colony in preparation for infectivity studies in PKDL and visceral leishmaniasis patients.
2018
In Sudan, a Phase II study to test both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM) began in Dooka, Sudan in 2018 and had recruited 39 patients by January 2019. Results are expected by mid-2021. Preparation for an infectivity study to confirm whether PKDL acts as a reservoir for ongoing leishmaniasis infection is underway.
2017
A Phase II study to test both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM) is under preparation in Sudan. Target recruitment will be 110 patients over two years.
Preparations for a PKDL infectivity study – studying the ability of a pathogen to establish a horizontal infection, that is not from parent to child – in Sudan began with the preparation of an insectarium.
2016
A Phase II study to assess the safety and efficacy of both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM), is planned in Sudan. A site visit was undertaken, and the protocol and study documents are being finalized for submission to ethics and regulatory authorities. In addition, preparations began for a PKDL infectivity study with the objective to establish the infectivity of PKDL patients to sandflies, to determine if PKDL patients maintain interepidemic transmission of visceral leishmaniasis.
News & resources
- 21 August 2024 - Disease-specific differences in pharmacokinetics of paromomycin and miltefosine between post-kala-azar dermal leishmaniasis and visceral leishmaniasis patients in Eastern Africa, The Journal of Infectious Diseases
- 30 July 2024 - Scientists discover new effective treatment for neglected skin disease, Nation Africa
- 25 July 2024 - Differences in the cellular immune response during and after treatment of Sudanese patients with post-kala-azar dermal leishmaniasis, and possible implications for outcome, Journal of Epidemiology and Global Health
- 20 July 2024 - Scientists find alternative cure for Kala-azar skin infection, The Star
- 17 July 2024 - The Science Explained: Good news for people living with PKDL in Eastern Africa
- 17 July 2024 - Clinical trial in Eastern Africa finds a shorter, safer, and more effective treatment for PKDL, a stigmatizing skin disease
- 16 April 2024 - Post-kala-azar dermal leishmaniasis (PKDL) drug efficacy study landscape: A systematic scoping review of clinical trials and observational studies to assess the feasibility of establishing an individual participant-level data (IPD) platform, PLOS Neglected Tropical Diseases
- 28 March 2024 - 2023 R&D portfolio in review: Leishmaniasis
- 21 November 2023 - Safety and efficacy of paromomycin/ miltefosine/ liposomal amphotericin B combinations for the treatment of post-kala-azar dermal leishmaniasis in Sudan: A phase II, open label, randomized, parallel arm study, PLOS Neglected Tropical Diseases
- 29 September 2021 - Development and validation of an HPLC-MS/MS method for the quantification of the anti-leishmanial drug miltefosine in human skin tissue, Journal of Pharmaceutical and Biomedical Analysis
- 12 September 2018 - New hope for PKDL patients in Africa as clinical trial aims to make treatment safer and easier
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