Knopp 2010.
Methods |
Design: parallel group randomized trial Duration of study: March to May 2009 Follow‐up: 21 days |
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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 |
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Interventions |
Treatment strategy: screening and treat all included participants
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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 |
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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. |
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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. |