Efficacy Albendazole and Levamisole Against STH on Unguja
Condition: Ascariasis; Trichuriasis
MeSH terms: Trichuriasis; Ascariasis; Ascaridiasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Field epidemiological studies undertaken during 2005 in four village locations in Northern
      Unguja, Zanzibar examined mothers and their pre-school aged children for helminth infections.

      The prevalence of Ascaris lumbricoides was found to have remained relatively high despite
      community-wide treatment with the mass administration of Albendazole (a WHO recommended
      de-wormer) in coordination with community vitamin A supplementation.

      One hypothesis for this is that the children and mothers had Ascaris infections more tolerant
      to Albendazole that subsequently failed to clear. It is necessary to compare the present drug
      efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on
      STH infections such patients a case-control setting to shed light on the putative resistance
      of local Ascaris/Trichuris to albendazole.

      In so doing, this should clarify whether there is resistance developing towards Albendazole
      and have possible implications for introducing combination therapies of Levamisole and
      Albendazole for first line de-worming mothers and their children in the future.
    

Detailed description: 
      The study was conducted in 10 villages on Unguja Island representative of urban, semi-urban
      and rural environments. After liaison with the local Shehia (the elected community leader)
      mothers and their children aged between 6 months and 5 years old were invited to attend a
      walk-in mobile clinic. In accordance with WHO sample size recommendations of 30 individuals
      per site and to cater for drop-out/non-compliance, target enrolment was about 50 mother and
      child pairs at each study village.

      Stool specimens were transported to the Helmtin Control Laboratory Unguja laboratory for
      visual inspection of stool consistency and presence of blood, after which a single Kato-Katz
      thick smear (41.7mg) was prepared. Eggs of all STH species were counted by inspection at 100x
      microscopy and expressed as a tally of eggs per gram (EPG). To ensure consistency of egg
      counts, slides were read by the same two technicians for each study village.

      10 Mother and child pairs found positive for Ascaris and/or Trichuris were randomised, by
      coin tossing, to receive either a single tablet of ALB (400mg) or an appropriate dose of LEV
      (2.5 mg/kg). A parasitological follow-up took place 18 days after treatment where a requested
      stool sample was analyzed by a single Kato-Katz thick smear for assessment of STH clearance.
      In accordance with WHO's 'no survey without service' all attendees were given an additional
      ALB tablet.
    

Intervention name(s): Albendazole; Levamisole
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 400mg; Single oral dose of 2.5mg/kg
Intervention MeSH terms: Albendazole; Levamisole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ascariasis; Trichuriasis; Drug resistance