Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
Efficacy and Safety of Albendazole and High-Dose Ivermectin Coadministration in School-Aged Children Infected With Trichuris trichiura in Honduras: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Matamoros Gabriela, Sánchez Ana, Gabrie José Antonio, Juárez Marisa, Ceballos Laura, Escalada Andrés, Rodríguez Carol, Martí-Soler Helena, Rueda María Mercedes, Canales Maritza, Lanusse Carlos, Cajal Pamela, Álvarez Luis, Cimino Rubén O, Krolewiecki Alejandro
Аннотация
BACKGROUND: The efficacy of currently available anthelminthics against Trichuris trichiura infections is significatively lower than for other soil-transmitted helminths. 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 4 treatment arms: arm 1, single-dose ALB (400 mg); arm 2, single-dose ALB (400 mg) plus IVM (600 μg/kg); arm 3, ALB (400 mg) for 3 consecutive days; or arm 4, ALB (400 mg) plus IVM (600 μg/kg) for 3 consecutive days. Efficacy was measured based on the egg reduction and cure rates, 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: Of 176 children randomized to 1 of the 4 treatment arms, 117 completed treatment and follow-up. The egg reduction rates for arms 1, 2, 3, and 4 were 47.7%, 96.7%, 72.1%, and 100%, respectively; with P values <.001 for comparisons between IVM groups and ALB-only arms. The cure rates were 4.2%, 88.6%, 33.3%, and 100%, respectively. A total of 48 adverse events (85.4% mild) 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 significantly improved treatment for the control of this infection.
CLINICAL TRIALS REGISTRATION: NCT04041453.
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 4 treatment arms: arm 1, single-dose ALB (400 mg); arm 2, single-dose ALB (400 mg) plus IVM (600 μg/kg); arm 3, ALB (400 mg) for 3 consecutive days; or arm 4, ALB (400 mg) plus IVM (600 μg/kg) for 3 consecutive days. Efficacy was measured based on the egg reduction and cure rates, 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: Of 176 children randomized to 1 of the 4 treatment arms, 117 completed treatment and follow-up. The egg reduction rates for arms 1, 2, 3, and 4 were 47.7%, 96.7%, 72.1%, and 100%, respectively; with P values <.001 for comparisons between IVM groups and ALB-only arms. The cure rates were 4.2%, 88.6%, 33.3%, and 100%, respectively. A total of 48 adverse events (85.4% mild) 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 significantly improved treatment for the control of this infection.
CLINICAL TRIALS REGISTRATION: NCT04041453.