Kobbe 2007 GHA.
Study characteristics | ||
Methods |
Trial design: RCT Trial dates: January 2003 to September 2005 Length of follow‐up: 24 months of age |
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Participants |
Number of participants: 1070 infants (535 infants in each arm) Inclusion criteria: age 3 months (4 weeks tolerance accepted); permanent residence in study area Exclusion criteria: severe illness |
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Interventions |
All participants concurrently received routine immunization with diphtheria‐pertussis‐tetanus (DPT) and measles vaccines |
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Outcomes |
Outcomes included in the review
Outcomes not included in the review: none |
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Notes |
Location: Afigya Sekyere district, Ghana Malaria transmission: holoendemic, intense perennial (with seasonal peaks), EIR = 400 infective bites/person/year Funding: the Bundesministerium für Bildung und Forschung (grant 01KA0202) The German Academic Exchange Service La Roche (Basel, Switzerland) manufactured study drugs free of charge Sanofi‐Aventis donated artesunate tablets for treatment of uncomplicated malaria episodes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The trial used computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | The trial used identical and centrally coded drugs and placebo |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "A study team of 2 doctors, a nurse, a technician, and a field worker, all blinded to group assignment, was responsible for recruitment, treatment, and subsequent visits" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "A study team of 2 doctors, a nurse, a technician, and a field worker, all blinded to group assignment, was responsible for recruitment, treatment, and subsequent visits" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Percentage loss of 18.5% (per protocol) |
Selective reporting (reporting bias) | Low risk | The trial reported most of the expected outcomes |
Other bias | Low risk | The trial appeared to be free of other sources of bias |