A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of Trichuris trichiura infection in school-aged children in Lambaréné and surroundings

Moure, P.A.N.; Maloum, M.N.; Manouana, G.P.; Lontchi, R.A.L.; Ngwese, M.M.; Edoa, J.R.; Zinsou, J.F.; Meulah, B.; Mahmoudou, S.; Dansou, E.M.N.; Honkpehedji, Y.J.; Adegbite, B.R.; Agnandji, S.T.; Ramharter, M.; Lell, B.; Borrmann, S.; Kremsner, P.G.; Dejon-Agobé, J.C.; Adegnika, A.A.

doi:doi:10.1128/aac.01211-23

Helminthiasis remains a public health issue in endemic areas. Various drugshave been proposed to improve efficacy against helminths. The study aimed to assessthe safety and efficacy of three different anthelmintic combinations to treat Trichuristrichiura infections. We conducted a randomized assessors-blind clinical trial involvingchildren aged 2–17 years with T. trichiura. Participants were randomly assigned to oneof three treatment arms. On the first and third days, all participants got albendazole400 mg, and on the second day, albendazole (arm A), mebendazole 500 mg (arm B), orpyrantel 125 mg/kg (arm C). We assessed treatment efficacy using the cure rate (CR) andegg reduction rate (ERR) at 3 and 6 weeks post-treatment. At 3 weeks post-treatment,ERR and CR were highest in study arm A [ERR = 94%, 95% confidence interval (CI):92–95; CR = 71%; 95% CI: 58–81] compared to the B and C arms. Decrease in ERR wassignificant only for arm B versus arm A (P-value <0.001); decrease in ERR...Show moreHelminthiasis remains a public health issue in endemic areas. Various drugshave been proposed to improve efficacy against helminths. The study aimed to assessthe safety and efficacy of three different anthelmintic combinations to treat Trichuristrichiura infections. We conducted a randomized assessors-blind clinical trial involvingchildren aged 2–17 years with T. trichiura. Participants were randomly assigned to oneof three treatment arms. On the first and third days, all participants got albendazole400 mg, and on the second day, albendazole (arm A), mebendazole 500 mg (arm B), orpyrantel 125 mg/kg (arm C). We assessed treatment efficacy using the cure rate (CR) andegg reduction rate (ERR) at 3 and 6 weeks post-treatment. At 3 weeks post-treatment,ERR and CR were highest in study arm A [ERR = 94%, 95% confidence interval (CI):92–95; CR = 71%; 95% CI: 58–81] compared to the B and C arms. Decrease in ERR wassignificant only for arm B versus arm A (P-value <0.001); decrease in ERR was significantfor arms B and C (P-value <0.001). No statistical difference was observed in CR whencomparing arms A and B (P-value =1.00) and C (P-value =0.27). At 6 weeks, a decreasein ERR was observed in three arms, significant only for arm C, 81% (95% CI: 78–83). Asignificant increase in egg counts was observed between 3 and 6 weeks post-treatment.All treatments were safe with mild adverse events. Albendazole 400 mg/day (arm A)showed the highest efficacy against trichuriasis. Nonetheless, this treatment regimenwas able to cure half of the treated individuals highlighting concerns about controllingthe transmission of T. trichiura.
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A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of Trichuris trichiura infection in school-aged children in Lambaréné and surroundings