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

A randomised clinical trial was conducted in Kabale District, southwestern Uganda, to compare the efficacies of single and double doses of a combination of 400 mg albendazole (ALB) and 500 mg 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 8 h 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 74, 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. [ClinicalTrials.gov identifier: NCT01050452].