title: Impact of treating young children with antimalarials with or without antibiotics on morbidity: a cluster-randomized controlled trial in Ghana.
abstract: BACKGROUND
  Community health workers in Dangme-West district, Ghana, treated children aged 2-59 months with fever with either artesunate-amodiaquine (AAQ) or AAQ plus amoxicillin (AAQ + AMX) within a cluster-randomized controlled trial (registration no. TDR/UNDP Trial registration A: 20189). The intervention was introduced in a stepped-wedge manner. The aim of the study was reduction of mortality. This paper reports on the reduction of morbidity, notably anaemia, severe anaemia and severe illness. Clusters of 100 children were randomized in to AAQ, AAQ + AMX and pre-intervention arms. Six months later the pre-intervention clusters were randomized in to the AAQ and AAQ + AMX arms.
  
  
  METHODS
  Data were collected in eight cross-sectional surveys. Using stratified sampling, 10 clusters were randomly selected per survey. Blood samples were taken to assess haemoglobin. Caregivers were interviewed about diseases (signs and symptoms) among their children in the preceding 14 days. Multivariate logistic regression analysis was used to determine the impact on anaemia, severe anaemia and severe illness.
  
  
  RESULTS
  Compared with the pre-intervention clusters, anaemia was reduced in the AAQ (OR = 0.20, 95% CI 0.12-0.33) and AAQ + AMX (OR = 0.23, 95% CI 0.15-0.36) clusters, severe anaemia was reduced in the AAQ (OR = 0.20, 95% CI 0.09-0.45) and AAQ + AMX (OR = 0.12, 95% CI 0.04-0.31) clusters and severe illness was reduced in the AAQ (OR = 0.46, 95% CI 0.26-0.80) and AAQ + AMX (OR = 0.38, 95% CI 0.22-0.63) clusters. No significant differences were found in outcome variables between the AAQ and AAQ + AMX clusters.
  
  
  CONCLUSIONS
  Treating fever with antimalarials significantly reduced the prevalence of anaemia, severe anaemia and severe illness. We found no significant reduction in outcomes when the AAQ and AAQ+AMX clusters were compared.
authors.affiliation: Research and Development Division, Ghana Health Service, PM Bag 190, Accra, Ghana.
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Chinbuah
authors.forename: Martin
authors.initials: M
authors.lastname: Adjuik
authors.forename: Frank
authors.initials: F
authors.lastname: Cobelens
authors.forename: Kwadwo A
authors.initials: KA
authors.lastname: Koram
authors.forename: Mercy
authors.initials: M
authors.lastname: Abbey
authors.forename: Margaret
authors.initials: M
authors.lastname: Gyapong
authors.forename: Piet A
authors.initials: PA
authors.lastname: Kager
authors.forename: John O
authors.initials: JO
authors.lastname: Gyapong
mesh_terms: D000655:Amodiaquine / Q000627:therapeutic use*; D000658:Amoxicillin / Q000627:therapeutic use*; D000740:Anemia / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000962:Antimalarials / Q000627:therapeutic use*; D037621:Artemisinins / Q000627:therapeutic use*; D017028:Caregivers; D002675:Child, Preschool; D003150:Community Health Workers; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D005869:Ghana; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007223:Infant; D007407:Interviews as Topic; D016015:Logistic Models; D008288:Malaria / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D015999:Multivariate Analysis; D012720:Severity of Illness Index
chemical_list: D000900:Anti-Bacterial Agents; D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D006454:Hemoglobins; C515299:amodiaquine, artesunate drug combination; D000655:Amodiaquine; D000658:Amoxicillin
keywords: Amoxicillin; Anaemia; Artesunate; Children; Community; Fever