Treatment Efficacy and Malaria TRANSmission After Artemisinin Combination Therapy 2 (TRANSACT2)
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the
      first line treatment policy in Kenya. AL is an efficacious drug that also has the capacity to
      reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the
      development of parasite resistance against AL. Clinical trials in Asia showed that
      mefloquine-artesunate (MQ-AS) may be more efficacious than AL and may have a more pronounced
      beneficial effect on post-treatment malaria transmission. MQ-AS is registered and used in
      Kenya but there have been no reported direct comparisons of AL and MQ-AS with clinical and
      transmission endpoints (i.e. adequately clearing parasites and preventing transmission to
      mosquitoes).

      Screening for molecular markers that are related to parasite susceptibility to ACT drugs and
      to post-ACT treatment malaria transmission can assist strategies to prevent the development
      and spread of ACT resistance.

      In the current study, we compare AL and MQ-AS for the treatment of uncomplicated malaria. Our
      endpoints are i) clinical efficacy, ii) post-treatment gametocytaemia by molecular
      techniques.

      In the current study, the investigators compare AL and MQ-AS for the treatment of
      uncomplicated malaria. The investigators endpoints are

      clinical efficacy post-treatment gametocytaemia by molecular techniques
    

Detailed description: 
      Accurate diagnosis followed by prompt and efficacious treatment is the backbone of any
      malaria control programme. However, malaria treatment has been facing huge challenges in
      recent years. A number of affordable antimalarial drugs have been used to cure malaria since
      the 1940s: these include chloroquine (CQ), sulphadoxine-pyrimethamine (SP; Fansidar®),
      mefloquine (MQ), amodiaquine (AQ) and quinine. The emergence and spread of resistance to
      these commonly-used drugs has been largely responsible for the worsening of the malaria
      situation observed in the past decades.

      Across the African continent, guidelines have recently been changed. The World Health
      Organization (WHO) recommends for falciparum malaria the use of combination therapies,
      preferably those containing artemisinin derivatives (ACT, artemisinin-based combination
      therapy). Artemisinin derivatives, e.g. artesunate, artemether and dihydroartemisinin, being
      extremely potent antimalarial agents are the ideal partners in combinations with other
      antimalarials. ACTs have three demonstrable advantages over conventional therapy, they i) are
      efficacious in clearing asexual parasites, ii) substantially reduce post-treatment gametocyte
      carriage and iii) "protect" the partner drug from selecting resistant parasites.

      In Kenya, both CQ and SP have lost clinical efficacy. CQ was replaced by SP in 1998 and in
      the year 2006, SP was effectively replaced by Artemether-Lumefantrine (AL: Coartem®). The
      policy change to the artemisinin-based drug AL is in line with the WHO recommendations to
      shift to ACT as first line antimalarial treatment.The most efficacious ACT, however, needs
      local comparisons in terms of treatment efficacy and transmission-reducing activity.
    

Intervention name(s): Mefloquine - Artesunate; Artemether-lumefantrine combination
Intervention type(s): Drug; Drug
Other intervention name(s): Artequin; Coartem
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Malaria treatment efficacy; Malaria transmission