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. 2020 Apr 14;2020(4):CD010599. doi: 10.1002/14651858.CD010599.pub2

Knopp 2010.

Methods Design: parallel group randomized trial
Duration of study: March to May 2009
Follow‐up: 21 days
Participants Country: Tanzania
Setting: school
Number included in study: 610
Age: mean 11 years
Sex: 55% girls
Inclusion criteria: children attending grades 1–7 in the 2 schools with written informed consent provided by parents or guardians, aged ≥ 5 years, sufficiently large stool sample to perform duplicate Kato‐Katz thick smears at baseline survey, infection with T trichiura, and submission of second stool sample subjected to duplicate Kato‐Katz thick smears before treatment
Exclusion criteria: pregnant (for girls), as verbally assessed by medical personnel; presence of systemic illnesses (e.g. fever or severe illness); and anthelmintic treatment within the previous 4 weeks
Lost at follow‐up: 62 (10.0%)
Number positive for A lumbricoides: 73
Number included in review: 64
Interventions Treatment strategy: screening and treat all included participants
  • Group 1: albendazole 400 mg single dose + placebo (n = 14)

  • Group 2: albendazole 400 mg single dose + ivermectin 200 μg/kg single dose (n = 14)

  • Group 3: mebendazole 500 mg single dose + placebo (n = 18)

  • Group 4: mebendazole 500 mg + ivermectin 200 μg/kg single dose (n = 18)

Outcomes Outcomes included:Ascaris prevalence pre‐ and post‐treatment, cure rates, pre‐ and post‐treatment GM epg, adverse events
Outcomes not included in review: anthelmintic efficacy for Trichuris and hookworm
Notes Diagnostic technique: Kato‐Katz
Funding support: Commission for Research Partnerships with Developing Countries (through the Swiss Agency for Development and Cooperation–sponsored program "Jeunes Chercheurs" to S.K.), the Swiss National Science Foundation (project PPOOB‐102883 and PPOOB‐119129), the EU (FP6 STREP CONTRAST project, contract 032203), and Burckhardt Foundation Basel.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The trial statistician was provided with the list of identification numbers of 618 T.trichiura‐positive children and generated a computer‐based random allocation sequence (numbers 1–4)."
Allocation concealment (selection bias) High risk Quote: "The numbers were decoded for each school by 1 of 2 researchers (S.K. for Kilombero and B.S. for Kinyasini) to assign children either to albendazole (400 mg; Laboratoria Wolfs) plus placebo (Hermes Edulcorants), albendazole plus ivermectin (200 mg/kg; Merck), mebendazole (500 mg; Janssen‐Cilag) plus placebo, or mebendazole plus ivermectin."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Trial medications were prepared in identical envelopes labelled with unique identification numbers and sealed. Because ivermectin is administered according to patient weight, ivermectin and placebo tablets were counted and packed according to children's weight. The gravure on the albendazole or mebendazole tablets was not identical, and placebos were slightly smaller than ivermectin tablets."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "All laboratory personnel, including the outcome assessors, were masked to group assignment."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 62 (10.0%) participants lost at follow‐up.
Selective reporting (reporting bias) Low risk All stated outcomes were reported.
Other bias Low risk No other obvious source of bias.