title: Monitoring of efficacy and safety of artemisinin-based anti-malarials for treatment of uncomplicated malaria: a review of evidence of implementation of anti-malarial therapeutic efficacy trials in Tanzania.
abstract: BACKGROUND
  Prompt diagnosis and effective treatment are considered the cornerstones of malaria control and artemisinin-based combination therapy (ACT) is currently the main anti-malarial drugs used for case management. After deployment of ACT due to widespread parasite resistance to the cheap and widely used anti-malarial drugs, chloroquine and sulphadoxine/pyrimethamine, the World Health Organization recommends regular surveillance to monitor the efficacy of the new drugs. The present paper assessed the implementation of anti-malarial efficacy testing for monitoring the therapeutic efficacy of ACT for treatment of uncomplicated malaria in Tanzania before and after policy changes in 2006.
  
  
  METHODS
  A literature search was performed for published clinical trials conducted in Tanzania from 2001 to 2014. It focused on studies which assessed at least one form of ACT for treatment of uncomplicated falciparum malaria in children less than 10 years and reported efficacy and safety of the tested anti-malarials. References were imported into the Endnote library and duplicates removed. An electronic matrix was developed in Microsoft Excel followed by full text review with predetermined criteria. Studies were independently assessed and information related to ACT efficacy and safety extracted.
  
  
  RESULTS
  Nine papers were selected from 125 papers screened. The efficacy of both artemether-lumefantrine (AL) and artesunate-amodiaquine (AS + AQ) against uncomplicated P. falciparum infections in Tanzania was high with PCR-corrected cure rates on day 28 of 91-100% and 88-93.8%, respectively. The highest day-3 parasite positivity rate was 1.4%. Adverse events ranged from mild to serious but were not directly attributed to the drugs.
  
  
  CONCLUSIONS
  ACT is efficacious and safe for treatment of uncomplicated malaria in Tanzania. However, few trials were conducted in Tanzania before and after policy changes in 2006 and thus more surveillance should be urgently undertaken to detect future changes in parasite sensitivity to ACT.
authors.affiliation: The Nelson Mandela African Institution of Science and Technology, P.O Box 447, Arusha, Tanzania. alex.shayo@gmail.com.
authors.forename: Alex
authors.initials: A
authors.lastname: Shayo
authors.affiliation: The Nelson Mandela African Institution of Science and Technology, P.O Box 447, Arusha, Tanzania. joram.buza@nm-aist.ac.tz.
authors.forename: Joram
authors.initials: J
authors.lastname: Buza
authors.affiliation: National Institute for Medical Research, Tanga Research Centre, P.O Box 5004, Tanga, Tanzania. deusishe@yahoo.com.
authors.forename: Deus S
authors.initials: DS
authors.lastname: Ishengoma
mesh_terms: D000962:Antimalarials / Q000009:adverse effects* / Q000627:therapeutic use*; D037621:Artemisinins / Q000009:adverse effects* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D013636:Tanzania; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D037621:Artemisinins; C031327:artemisinin