Efficacy And Safety Of AL For The Treatment Of Uncomplicated Falciparum Malaria In Mainland Tanzania
Condition: Uncomplicated Malaria
MeSH terms: Malaria
Study type: Observational [Patient Registry]

Summary: 
      Following the development of drug resistance to antimalarial first line treatment of
      uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health -
      Tanzania, introduced ACTs with AL as first line treatment for uncomplicated falciparum
      malaria in 2006. In the advent of wide scale deployment of ACT together with strengthened
      vector control with LLIN in mainland Tanzania, there is a trend of shrinking the burden of
      malaria. The decline of outpatient malaria cases in recent years and declining entomological
      inoculation rates (EIR) that are currently being recorded in most areas that were before
      considered to be holo/hyper-endemic to malaria transmission is another indicator of the shift
      in the epidemiology of malaria transmission in Tanzania. This current shift provides a new
      and yet critical challenge with regards to assessment and monitoring of the efficacy of the
      first-line treatment specifically considering that artemisinin resistance has been confirmed
      in the Greater Mekong sub-region. The aim of the study was to set up a system for country
      wide representative surveillance to obtain data of the safety and efficacy of AL following
      countrywide use of ACTs for treatment of uncomplicated malaria in Tanzania. The study was
      conducted in the framework of the existing NMCP sentinel sites that are ecological
      representative for malaria endemicity in Tanzania Objective: To assess the efficacy and
      safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine
      for the treatment of uncomplicated falciparum malaria in Tanzania.

      Methods: The study was conducted in eight sentinel sites of NMCP (Kyela, Mkuzi, Kibaha,
      Ujiji, Nagaga, Chamwino, Igombe and Mlimba) in mainland Tanzania. Four sentinel sites
      (Mlimba, Mkuzi, Kibaha, and Ujiji) were covered in 2016 and the rest will be involved in the
      second round to be undertaken in 2017.

      Patients were treated with AL for 3 days and the study was conducted from April to Sept 2016.
      The results of this study will assist the Ministry of Health to monitor the efficacy and
      safety of the ACTs in Tanzania, provide baseline data on parasite clearance time and for
      assessing the current national treatment guidelines for uncomplicated falciparum malaria.
    

Detailed description: 
      The study was on safety and efficacy of artemether lumefantrine for the treatment of
      uncomplicated malaria, to be done in 8 National Malaria Control Programme sentinel sites The
      study was proposed to be done in 2 phases; the first phase in Mkuzi, Ujiji, Kibaha and Mlimba
      fro April 2016-Sept 2016 The second phase to be done in the other 4 sites of Igombe,
      Chwamwino, Kyela and Nagaga from February - October 2017
    

Intervention name(s): Artemether-Lumefantrine
Intervention type(s): Drug
Other intervention name(s): Coartem
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients aged 6 months-10 years and with uncomplicated falciparum malaria presenting at
        the study health clinics. Parents or guardians will give informed consent on behalf of
        their children.
      
Keywords: Efficacy safety uncomplicated malaria AL