Failure of an Innovative Low-Cost, Noninvasive Thermotherapy Device for Treating Cutaneous Leishmaniasis Caused by Leishmania tropica in Pakistan
Autor: | Martin P. Grobusch, Charity Kamau, Suzette Kämink, Naveeda Akhtar Qureshi, Henk D. F. H. Schallig, Koert Ritmeijer, Muhammad Asim Ansari, Shakil Ashraf, Ahmed Abdi, Jena Fernhout |
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Přispěvatelé: | Medical Microbiology and Infection Prevention, AII - Infectious diseases, Infectious diseases, APH - Aging & Later Life, APH - Global Health |
Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
Leishmania tropica biology business.industry Standard treatment 030231 tropical medicine Leishmaniasis medicine.disease Interim analysis biology.organism_classification Dermatology 03 medical and health sciences 0302 clinical medicine Infectious Diseases Cutaneous leishmaniasis Interquartile range Virology parasitic diseases medicine Antimonial Parasitology Leishmania major business |
Zdroj: | American journal of tropical medicine and hygiene, 101(6), 1373-1379. American Society of Tropical Medicine and Hygiene |
ISSN: | 1476-1645 0002-9637 |
DOI: | 10.4269/ajtmh.19-0430 |
Popis: | Cutaneous leishmaniasis (CL), a neglected parasitic skin disease, is endemic in Pakistan, where Leishmania tropica and Leishmania major are the causative protozoan species. Standard treatment with antimonial injections is long, painful, and costly; has toxic side effects; and is not always available in public hospitals. Small pilot studies have previously evaluated a low-cost and noninvasive hand-held exothermic crystallization thermotherapy for cutaneous leishmaniasis (HECT-CL) device. We aimed to further establish the effectiveness, safety, and feasibility of HECT-CL in L. tropica. In a prospective observational study, patients with parasitological confirmation of CL were treated using the HECT-CL heat pack for 3 minutes with an initial temperature of 52-53°C for 7 consecutive days. Dried blood spot samples were taken for species identification by polymerase chain reaction (PCR). Effectiveness was assessed by using medical photographs and measurements of the lesion size at baseline and subsequent follow-up visits, for up to 180 days. We intended to enroll 317 patients. The HECT-CL treatment was easy to apply and well tolerated. Species identification demonstrated the presence of L. tropica. Interim analysis of 56 patients showed a failure rate of 91% at follow-up (median 45 days after treatment, interquartile range 30-60 days). Enrollment of patients was prematurely suspended because of futility. This study showed a high failure rate for HECT-CL thermotherapy in this setting. Leishmania tropica is known to be less sensitive to antileishmanial drugs, more temperature-resistant, and spontaneous healing is slower than that in L. major. More research is needed to identify low-cost, effective, and more patient-friendly treatment for L. tropica. |
Databáze: | OpenAIRE |
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