title: Treatment guided by rapid diagnostic tests for malaria in Tanzanian children: safety and alternative bacterial diagnoses.
abstract: BACKGROUND
  WHO guidelines for the treatment of young children with suspected malaria have recently changed from presumptive treatment to anti-malarial treatment guided by a blood slide or malaria rapid diagnostic test (RDT). However, there is limited evidence of the safety of this policy in routine outpatient settings in Africa.
  
  
  METHODS
  Children 3-59 months of age with a non-severe febrile illness and no obvious cause were enrolled over a period of one year in a malaria endemic area of Tanzania. Treatment was determined by the results of a clinical examination and RDT result, and blood culture and serum lactate were also collected. RDT-negative children were followed up over 14 days.
  
  
  RESULTS
  Over the course of one year, 965 children were enrolled; 158 (16.4%) were RDT-positive and treated with artemether-lumefantrine and 807 (83.4%) were RDT-negative and treated with non-anti-malarial medicines. Compared with RDT-positives, RDT-negative children were on average younger with a lower axillary temperature and more likely to have a history of cough or difficulty in breathing. Six (0.6%) children became RDT-positive after enrollment, all of whom were PCR-negative for Plasmodium falciparum DNA at enrollment. In addition, 12 (1.2%) children were admitted to hospital, one with possible malaria, none of whom died. A bacterial pathogen was identified in 9/965 (0.9%) children, eight of whom were RDT-negative and one was RDT-positive, but slide-negative. Excluding three children with Salmonella typhi, all of the children with bacteraemia were ≤ 12 months of age. Compared to double-read research slide results RDTs had a sensitivity of 97.8% (95% CI 96.9-98.7) and specificity of 96.3% (95% CI 96.3-98.4).
  
  
  CONCLUSIONS
  Use of RDTs to direct the use of anti-malarial drugs in young children did not result in any missed diagnoses of malaria although new infections soon after a consultation with a negative RDT result may undermine confidence in results. Invasive bacterial disease is uncommon in children with non-severe illness and most cases occurred in infants with a current fever.
authors: 1National Institute for Medical Research, Amani Centre, Muheza, Tanga,Tanzania.
authors: George
authors: G
authors: Mtove
authors: Ilse Ce
authors: IC
authors: Hendriksen
authors: Ben
authors: B
authors: Amos
authors: Hedwiga
authors: H
authors: Mrema
authors: Victor
authors: V
authors: Mandia
authors: Alphaxard
authors: A
authors: Manjurano
authors: Florida
authors: F
authors: Muro
authors: Alma
authors: A
authors: Sykes
authors: Helena
authors: H
authors: Hildenwall
authors: Christopher J M
authors: CJ
authors: Whitty
authors: Hugh
authors: H
authors: Reyburn
mesh_terms: D000962:Antimalarials / Q000008:administration & dosage*; D016470:Bacteremia / Q000175:diagnosis; D001769:Blood / Q000382:microbiology / Q000469:parasitology; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods*; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D007773:Lactates / Q000097:blood; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D012680:Sensitivity and Specificity; D013636:Tanzania
chemical_list: D000962:Antimalarials; D007773:Lactates