Skip to main content
. 2021 Jul 17;2021(7):CD011525. doi: 10.1002/14651858.CD011525.pub3

Kobbe 2007 GHA.

Study characteristics
Methods Trial design: RCT
Trial dates: January 2003 to September 2005
Length of follow‐up: 24 months of age
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
Interventions
  • Intervention: SP (250 mg sulfadoxine and 12.5 mg pyrimethamine) given at 3, 9, and 15 months of age: One tablet at 3, 9, and 15 months of age

  • Placebo: identical placebos given at the same time points with iPTi


All participants concurrently received routine immunization with diphtheria‐pertussis‐tetanus (DPT) and measles vaccines
Outcomes Outcomes included in the review
  • Clinical malaria

  • Anaemia

  • Hospital admissions

  • All‐cause mortality

  • Adverse events


Outcomes not included in the review: none
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
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