Effectiveness of Antileishmanial Treatments in Three Endemic Areas of Colombia: A Community-Based Cohort Study

María del Mar Castro Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia;
Universidad Icesi, Cali, Colombia

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Alejandra María Del Castillo Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia;

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Ruth Mabel Castillo Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia;
Universidad Icesi, Cali, Colombia

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Alexandra Cossio Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia;
Universidad Icesi, Cali, Colombia

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Patricia Castaño Grajales Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia;

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Yeison Gutiérrez Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia;

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Neal Alexander Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia;
Universidad Icesi, Cali, Colombia

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ABSTRACT.

The effectiveness of treatment of cutaneous leishmaniasis (CL) in rural settings remains underexplored. This study assessed the effectiveness of standard antileishmanial treatments using a community-based approach supported by mobile health (mHealth) in three rural areas of Colombia. From January 2018 to September 2021, we assessed treatment outcomes, adherence, and adverse drug reactions in CL patients, with the support of the Guaral+ST app. Treatment decisions were made by providers at health facilities at each site in accordance with national guidelines, whereas treatment follow-up and presumptive case identification were made by trained community leaders and health agents at the community level. In total, 231 participants received antileishmanial treatment (63 received miltefosine, 110 meglumine antimoniate, and 58 pentamidine). Disease presentation was mild (median number of lesions = 1, interquartile range [IQR]: 1–2) and of short duration (1.5 months, IQR: 1–3). The strategy yielded information on the therapeutic outcomes in 81% of study participants. Effectiveness, measured as the proportion of cure at 90 to 180 days, was 86.3% (95% CI: 73.3–93.48) for miltefosine; 77.6% (67.5–85.3) for meglumine antimoniate, and 73.1% (59.0–83.6) for pentamidine. The effectiveness of pentamidine in children ≤10 years old was 79.4% (61.6–90.3). This is one of the few reports of effectiveness of pentamidine in children with prospective data collection in the Americas. Adverse drug reactions occurred in 32% of patients, most frequently with meglumine antimoniate. Our findings demonstrate that standard antileishmanial treatments are effective in rural areas where the disease is endemic and that mHealth has a pivotal role in improving patient follow-up and data collection on therapeutic outcomes.

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Author Notes

Financial support: This study was financed by NIH Tropical Medicine Research Center award number U19AI129910 and partly funded by Ministerio de Ciencias Tecnología e Innovación–Minciencias” (https://minciencias.gov.co/) (Grant no. 222972553501). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Disclosures: This study was approved and monitored by the Ethics Committee of the CIDEIM in accordance with national and international regulations (reference number 1272, date of initial approval: October 30, 2017). Written informed consent was obtained from all participants and guardians of participants under 18 years of age. Assent was obtained from children ≥7 years of age. Approval of the indigenous governor of the Emberá communities in the Pueblo Rico study site was obtained prior to the initiation of the study, in addition to individual consent by community members.

Current contact information: María del Mar Castro, Ruth Mabel Castillo, Alexandra Cossio, and Neal Alexander, Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia, and Universidad Icesi, Cali, Colombia, E-mails: mcastro@cideim.org.co, rmcastillo@cideim.org.co, acossio@cideim.org.co, and nalexander@cideim.org.co. Alejandra María Del Castillo, Patricia Castaño Grajales, and Yeison Gutiérrez, Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia. E-mails: adel168@unab.edu.co, patriciacastanograjales@gmail.com, and yeison.gutierrez@ucm.edu.co.

Address correspondence to María del Mar Castro, Calle 18 # 122-135, Campus de la Universidad Icesi (Edificio O-CIDEIM), Cali, Colombia. E-mail: mcastro@cideim.org.co
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