Efficacy and safety of albendazole and high-dose ivermectin co-administration in school-aged children infected with Trichuris trichiura in Honduras: A Randomized Controlled Trial.

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.