PMID- 34277476 OWN - NLM STAT- MEDLINE DCOM- 20210723 LR - 20210723 IS - 2235-2988 (Electronic) IS - 2235-2988 (Linking) VI - 11 DP - 2021 TI - A Pilot Randomized Clinical Trial: Oral Miltefosine and Pentavalent Antimonials Associated With Pentoxifylline for the Treatment of American Tegumentary Leishmaniasis. PG - 700323 LID - 10.3389/fcimb.2021.700323 [doi] LID - 700323 AB - INTRODUCTION: American tegumentary leishmaniasis (ATL), which can present as either cutaneous (CL) or mucosal leishmaniasis (ML), is endemic in South America, and first-line antimonial treatments are known for their wide range of adverse effects (AEs). Growing reports of drug resistance increase the urgency of the need for better treatment options. The objective of this pilot clinical trial was to assess the efficacy of and AEs associated with the oral combination of miltefosine and pentoxifylline based on a post hoc analysis. METHODS: A pilot, randomized, open-label clinical trial was performed. The experimental group (M+P) received 50 mg twice a day (BID) miltefosine and 400 mg three times a day (TID) pentoxifylline, and the control group (A+P) received 20 mg Sb+V/kg/day intravenously and 400 mg TID pentoxifylline. Patients with ML received treatment for 28 days, and patients with CL received treatment for 20 days. RESULTS: Forty-three patients were included: 25 with ML and 18 with CL caused by L.(V.) braziliensis. AEs were more frequent in the A+P group (p=0.322), and there was a need for treatment interruption due to severe AEs (p=0.027). Patients with CL had a higher chance of achieving a cure (p=0.042) and a higher risk of AEs (p=0.033). There was no difference in the chance of a cure based on the treatment (p=0.058). CONCLUSION: In this pilot randomized clinical trial, M+P treatment and A+P treatment yielded similar cure rates, and the former was associated with a lower risk of AEs. Future studies with more patients and longer follow-up are recommended. CI - Copyright (c) 2021 Martins, Barroso, Rodrigues, da Motta, Freire, Pereira, Kurisky, Gomes and Sampaio. FAU - Martins, Sofia Sales AU - Martins SS AD - Pos-Graduacao de Ciencias da Saude da Faculdade de Ciencias Saude, Universidade de Brasilia, Brasilia, Brazil. AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. FAU - Barroso, Daniel Holanda AU - Barroso DH AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. AD - Pos-Graduacao de Ciencias Medicas da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. AD - Laboratorio de Dermatomicologia da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. FAU - Rodrigues, Bruna Cortes AU - Rodrigues BC AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. AD - Pos-Graduacao de Ciencias Medicas da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. FAU - da Motta, Jorgeth de Oliveira Carneiro AU - da Motta JOC AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. FAU - Freire, Gustavo Subtil Magalhaes AU - Freire GSM AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. FAU - Pereira, Ledice Inacia de Araujo AU - Pereira LIA AD - Departamento de Doencas Infecciosas, Hospital de Doencas Tropicais Dr. Anuar Auad (HDT), Goiania, Brazil. FAU - Kurisky, Patricia Shu AU - Kurisky PS AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. AD - Pos-Graduacao de Ciencias Medicas da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. FAU - Gomes, Ciro Martins AU - Gomes CM AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. AD - Pos-Graduacao de Ciencias Medicas da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. AD - Laboratorio de Dermatomicologia da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. FAU - Sampaio, Raimunda Nonata Ribeiro AU - Sampaio RNR AD - Pos-Graduacao de Ciencias da Saude da Faculdade de Ciencias Saude, Universidade de Brasilia, Brasilia, Brazil. AD - Hospital Universitario de Brasilia, Universidade de Brasilia, Brasilia, Brazil. AD - Pos-Graduacao de Ciencias Medicas da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. AD - Laboratorio de Dermatomicologia da Faculdade de Medicina, Universidade de Brasilia, Brasilia, Brazil. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210701 PL - Switzerland TA - Front Cell Infect Microbiol JT - Frontiers in cellular and infection microbiology JID - 101585359 RN - 0 (Antiprotozoal Agents) RN - 107-73-3 (Phosphorylcholine) RN - 53EY29W7EC (miltefosine) RN - SD6QCT3TSU (Pentoxifylline) SB - IM MH - *Antiprotozoal Agents/therapeutic use MH - Humans MH - *Leishmaniasis, Cutaneous/drug therapy MH - *Pentoxifylline/therapeutic use MH - Phosphorylcholine/analogs & derivatives MH - Pilot Projects MH - Treatment Outcome MH - United States PMC - PMC8281031 OTO - NOTNLM OT - American tegumentary leishmaniasis OT - cutaneous leishmaniasis OT - miltefosine OT - mucosal leishmaniasis OT - pentavalent antimonial OT - pentoxifylline OT - randomized clinical trial COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/07/20 06:00 MHDA- 2021/07/24 06:00 PMCR- 2021/01/01 CRDT- 2021/07/19 05:59 PHST- 2021/04/26 00:00 [received] PHST- 2021/06/14 00:00 [accepted] PHST- 2021/07/19 05:59 [entrez] PHST- 2021/07/20 06:00 [pubmed] PHST- 2021/07/24 06:00 [medline] PHST- 2021/01/01 00:00 [pmc-release] AID - 10.3389/fcimb.2021.700323 [doi] PST - epublish SO - Front Cell Infect Microbiol. 2021 Jul 1;11:700323. doi: 10.3389/fcimb.2021.700323. eCollection 2021.