Gabriela Matamoros1,2, Ana Sánchez1,2, José Antonio Gabrie2, Marisa Juárez3, Laura Ceballos4, Andrés Escalada3, Carol Rodríguez5, Helena Martí-Soler6, María Mercedes Rueda5, Maritza Canales5, Carlos Lanusse4, Pamela Cajal3, Luis Álvarez4, Rubén O Cimino3, Alejandro Krolewiecki3,4. 1. Instituto de Investigaciones en Microbiología, Universidad Nacional Autónoma de Honduras. 2. Faculty of Applied Health Sciences, Brock University, Ontario. Canada. 3. Instituto de Investigaciones de Enfermedades Tropicales (IIET-CONICET), Sede Regional Orán, Universidad Nacional de Salta, Argentina. 4. Laboratorio de Farmacología, Centro de Investigación Veterinaria de Tandil (CIVETAN), UNCPBA-CICPBA-CONICET, Facultad de Ciencias Veterinarias, Universidad Nacional del Centro de la Provincia de Buenos Aires, Tandil, Argentina. 5. Escuela de Microbiología, Universidad Nacional Autónoma de Honduras. 6. ISGlobal, Hospital Clínic- Universitat de Barcelona, Barcelona, Spain.
Abstract
BACKGROUND: The efficacy of currently available anthelminthics against Trichuris trichiura infections is significatively lower than for other soil-transmitted helminths (STH). The combination of ivermectin (IVM) and albendazole (ALB) has shown significant improvements in efficacy. METHODS:Safety and efficacy randomized controlled clinical trial comparing 3 experimental regimens against ALB monotherapy for the treatment of T. trichiura infections in northern Honduras. Infected children were randomized to one of the following treatments: (Arm 1) single-dose ALB 400 mg; (Arm 2) single-dose ALB 400 mg/IVM 600 μg/kg; (Arm 3) ALB 400 mg for 3 consecutive days; or (Arm 4) ALB 400 mg/IVM 600 μg/kg for 3 consecutive days. Efficacy was measured through egg reduction rate (ERR) and cure rate (CR), both assessed 14-21 days after treatment using the Kato-Katz method. Safety was evaluated by analyzing the frequency and severity of adverse events. RESULTS: A total of 176 children were randomized to one of the 4 treatment arms, 117 completed treatment and follow-up. The ERR for Arms 1 to 4 were: 47.7%, 96.7%, 72.1% and 100%, respectively; with p-values <0.001 between IVM groups and ALB only arms. The CRs were 4.2%, 88.6%, 33.3% and 100%, respectively. A total of 48 (85.4% mild) AEs were reported in 36 children. CONCLUSIONS: The combined use of ALB and high-dose IVM is a highly effective and well tolerated treatment for the treatment of T. trichiura infections offering a significantly improved treatment for the control of this infection.
RCT Entities:
BACKGROUND: The efficacy of currently available anthelminthics against Trichuris trichiura infections is significatively lower than for other soil-transmitted helminths (STH). The combination of ivermectin (IVM) and albendazole (ALB) has shown significant improvements in efficacy. METHODS: Safety and efficacy randomized controlled clinical trial comparing 3 experimental regimens against ALB monotherapy for the treatment of T. trichiura infections in northern Honduras. Infectedchildren were randomized to one of the following treatments: (Arm 1) single-dose ALB 400 mg; (Arm 2) single-dose ALB 400 mg/IVM 600 μg/kg; (Arm 3) ALB 400 mg for 3 consecutive days; or (Arm 4) ALB 400 mg/IVM 600 μg/kg for 3 consecutive days. Efficacy was measured through egg reduction rate (ERR) and cure rate (CR), both assessed 14-21 days after treatment using the Kato-Katz method. Safety was evaluated by analyzing the frequency and severity of adverse events. RESULTS: A total of 176 children were randomized to one of the 4 treatment arms, 117 completed treatment and follow-up. The ERR for Arms 1 to 4 were: 47.7%, 96.7%, 72.1% and 100%, respectively; with p-values <0.001 between IVM groups and ALB only arms. The CRs were 4.2%, 88.6%, 33.3% and 100%, respectively. A total of 48 (85.4% mild) AEs were reported in 36 children. CONCLUSIONS: The combined use of ALB and high-dose IVM is a highly effective and well tolerated treatment for the treatment of T. trichiura infections offering a significantly improved treatment for the control of this infection.
Authors: Greisi Curico; Paul García-Bardales; Tackeshy Pinedo; Wagner Shapiama; Miguel Moncada-Yaicate; Lucero Romaina; Pablo P Yori; Maribel Paredes-Olortegui; Graciela Meza-Sánchez; Andrés G Lescano; Valerie A Paz-Soldan; Francesca Schiaffino; Richard A Oberhelman; Margaret N Kosek Journal: BMC Infect Dis Date: 2022-06-07 Impact factor: 3.667
Authors: L Ceballos; E Nieves; M Juárez; R Aveldaño; M Travacio; J Martos; R Cimino; J L Walson; A Krolewiecki; C Lanusse; L Alvarez Journal: Antimicrob Agents Chemother Date: 2021-08-17 Impact factor: 5.191
Authors: Alejandro Krolewiecki; Adrián Lifschitz; Matías Moragas; Marina Travacio; Ricardo Valentini; Daniel F Alonso; Rubén Solari; Marcelo A Tinelli; Rubén O Cimino; Luis Álvarez; Pedro E Fleitas; Laura Ceballos; Marcelo Golemba; Florencia Fernández; Diego Fernández de Oliveira; German Astudillo; Inés Baeck; Javier Farina; Georgina A Cardama; Andrea Mangano; Eduardo Spitzer; Silvia Gold; Carlos Lanusse Journal: EClinicalMedicine Date: 2021-06-18
Authors: Marcos Alejandro Mayer; Alejandro Krolewiecki; Alejandro Ferrero; Marcelo Bocchio; Juan Barbero; Marcos Miguel; Ariel Paladini; Carlos Delgado; Juan Ramón Ojeda; Claudia Elorza; Ana Bertone; Pedro Emanuel Fleitas; Gustavo Vera; Mario Rubén Kohan Journal: Front Public Health Date: 2022-02-22