Prevalence Survey of Antimalarial Drug Resistance Markers
Condition: Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      Study is cross-sectional and observational with one-time dried-blood spot sample collection
      from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or
      monoinfection). Samples will be analysed for the presence of molecular markers of resistance
      to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene
      amplifications of pfpm2, and additional mutations which may be identified during the course
      of the trial) in the first instance. Testing to detect additional markers of antimalarial
      drug resistance will also be performed where feasible. Prevalence of mutations will be
      summarized and mapped to provide intelligence on antimalarial drug resistance in the region
      of interest.
    

Detailed description: 
      Malaria Malaria is caused by a mosquito-borne, protozoan parasite belonging to the genus
      Plasmodium. Of the five species of Plasmodium that infect humans, Plasmodium falciparum is
      the most deadly and is responsible for the majority of malaria disease and death. Every year,
      falciparum malaria causes disease in hundreds of millions of people living in the tropics and
      subtropics, killing a million or more according to some estimates. The vast majority of these
      deaths occur in sub-Saharan Africa, mostly among young children and infants. When treated
      with effective antimalarial drugs, malaria can be cured completely.

      Antimalarial drug resistance The emergence in Southeast Asia and the subsequent global spread
      of drug resistant malaria was a major factor contributing to the failure of the first global
      malaria eradication campaign in the mid-20th century (1). The widespread implementation of
      highly effective artemisinin-based combination therapy (ACT) for malaria has contributed to
      significant gains in global control and elimination efforts and has brought malaria
      eradication back on the agenda, 40 years after the first global malaria eradication campaign
      was abandoned (2). However the gains seen in the past decade are now at risk as parasite
      resistance to artemisinin compounds has been confirmed in Southeast Asia and threatens Africa
      once again (3-8). In the absence of effective vaccines, it is critical to prolong the usable
      life of antimalarial drugs by judicious implementation of treatment strategies.

      Primary Objective To measure prevalence of established and candidate molecular markers of
      drug resistant malaria in Greater Mekong Subregion

      Secondary Objective To map the geographical and temporal changes in prevalence of molecular
      markers of antimalarial drug resistance in Greater Mekong Subregion

      Funder: EXPERTISE FRANCE Grant reference number: Expertise France reference 15SANIN211
    

Intervention name(s): Blood Collection; Dried Blood Spot
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): blood smear and/or rapid diagnostic; Dried Blood Spot on filter paper
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients age 6 months - 75 years presenting at study site with confirmed P. falciparum
        infection
      
Biospecimen description: 
      Collect blood for malaria diagnostic testing (blood smear and/or rapid diagnostic test) and
      dried blood spot on filter paper
    
Keywords: Plasmodium falciparum; Prevalence Survey; Antimalarial Drug