Efficacy of single and double doses of albendazole and mebendazole alone and in combination in the treatment of Trichuris trichiura in school-age children in Uganda

Abstract

A randomised clinical trial was conducted in Kabale District, southwestern Uganda, to compare the efficacies of single and double doses of a combination of 400mg albendazole (ALB) and 500mg mebendazole (MBZ) with those of single and double doses of each drug given alone in the treatment of Trichuris trichiura. Infected pupils (n=611) were randomised to six treatment groups. Three groups received either a single dose of ALB, MBZ or the combination (ALB+MBZ). The other three groups received either a double dose of ALB (ALB/ALB), MBZ (MBZ/MBZ) or the combination (ALB+MBZ/ALB+MBZ). All double doses were given 8h apart. Children were followed-up weekly for 1 month. Cure rates were significantly higher using double doses compared with single doses (irrespective of drug; z=-4.02, P<0.0005) as well as using the drug combination compared with single drugs (irrespective of doses; z=-7.64, P<0.0005). Cure rates measured at Day 7 were significantly higher than on Days 14 and 21 after treatment (Day 14, z=9.90, P<0.0005; Day 21, z=7.36, P<0.0005). Geometric mean (GM) intensities of positives were significantly lower on Day 7 compared with all other subsequent days (P<0.00005), and on Day 28 GM intensities reached pre-treatment levels (P=0.096). Whilst there was no difference in egg excretion between single and double doses of the same drug or drug combination (F((df)(1))=0.28, P=0.60), the combination treatment resulted in lower egg excretion than use of single drugs (F((df)(2))=50.90, P<0.00005). All the tested regimens of ALB and MBZ had low cure rates against T. trichiura in Uganda, but both combination treatments showed satisfactory egg reduction rates 3 weeks after treatment.

Trial registration: ClinicalTrials.gov NCT01050452.