title: The acceptability and safety of praziquantel alone and in combination with mebendazole in the treatment of Schistosoma mansoni and soil-transmitted helminthiasis in children aged 1-4 years in Uganda.
abstract: OBJECTIVE
  There is limited information on the acceptability and safety of praziquantel for treatment of schistosomiasis in children below the age of four years. In addition, although mebendazole has been extensively used together with praziquantel against infections with schistosomiasis and soil-transmitted helminthiasis (STH) in school-aged children, no specific acceptability or safety studies have been published on this drug combination in younger children.
  
  
  METHODS
  A randomized clinical trial was conducted to determine the safety of praziquantel alone and in combination with mebendazole in the treatment of Schistosoma mansoni and STH in children aged 1 to 4 years.
  
  
  RESULTS
  A total of 596 children from Bwondha fishing community in Mayuge district and Wang-Kado fishing community in Nebbi district were investigated using duplicate Kato-Katz thick smears of two stool samples and 130 (21·8%) were found infected with S. mansoni. Of these, 19·2% (25) had heavy intensity of infections. Of the infected children, 82 were included and randomised into praziquantel (40 mg/kg) + mebendazole (500 mg) or praziquantel (40 mg/kg) alone.
  
  
  CONCLUSIONS
  Many symptoms were reported before treatment while very few were reported after treatment and all on treatment day. No serious adverse events were reported or observed after treatment. Praziquantel with or without mebendazole was well tolerated in small children in the study area.
authors.affiliation: Vector Control Division, Ministry of Health, P.O. Box 1661, Kampala, Uganda. harrietlwanga@ymail.com
authors.forename: Harriet
authors.initials: H
authors.lastname: Namwanje
authors.forename: Narcis B
authors.initials: NB
authors.lastname: Kabatereine
authors.forename: Annette
authors.initials: A
authors.lastname: Olsen
mesh_terms: D000818:Animals; D000871:Anthelmintics / Q000008:administration & dosage* / Q000009:adverse effects; D001196:Ascariasis / Q000188:drug therapy / Q000469:parasitology; D017164:Ascaris lumbricoides / Q000302:isolation & purification; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005243:Feces / Q000469:parasitology; D005260:Female; D006373:Helminthiasis / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D006725:Hookworm Infections / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D007223:Infant; D008297:Male; D008463:Mebendazole / Q000008:administration & dosage* / Q000009:adverse effects; D010270:Parasite Egg Count; D011223:Praziquantel / Q000008:administration & dosage* / Q000009:adverse effects; D015995:Prevalence; D012550:Schistosoma mansoni / Q000302:isolation & purification; D012555:Schistosomiasis mansoni / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D016037:Single-Blind Method; D012987:Soil / Q000469:parasitology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014257:Trichuriasis / Q000188:drug therapy / Q000453:epidemiology; D014454:Uganda / Q000453:epidemiology
chemical_list: D000871:Anthelmintics; D012987:Soil; D011223:Praziquantel; D008463:Mebendazole