Last Updated

24 Oct 2018

Assess the micro-epidemiology of resistant falciparum malaria in SE Asia and to perform and evaluate an intervention with targeted chemo-elimination through a modified mass drug administration approach (Viet Nam)

Objectives

This a multinational clinical and laboratory project to evaluate targeted chemo-elimination (TCE) as a strategy to eliminate artemisinin-resistant P. falciparum. In areas where artemisinin-resistant falciparum malaria has been identified, the team will measure the impact of repeated TCE on the incidence of malaria, the size and the genetic structure of the malaria parasite population and the transmission of malaria, and the progression of artemisinin resistance.

Epidemiological methods of assessment will be developed and refined and the acceptability, safety, effectiveness, costs and feasibility of TCE will be assessed, providing tools for scale-up if it is proved effective.

The specific objectives are to:

  1. Assess the safety and acceptability of targeted malaria elimination to eliminate the sub-microscopic reservoir of P. falciparum in an area of artemisinin resistance.
  2. Assess the feasibility of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHP) + primaquine (P)
  3. Assess the impact of MDA with DHP+P on the sub-microscopic reservoir.
  4. Study the re-emergence of P. falciparum if and when it occurs
  5. Explore to what extent the sub-microscopic reservoir contribute to transmission

Principal Institution(s)

Principal Investigator
Rationale and Abstract
  • Drug & regimen: 3 monthly rounds of dihydroartemisinin-piperaquine (DP) (7 mg/kg dihydroartemisinin and 55 mg/kg piperaquine) for 3 days plus a single low dose of primaquine (PQ), mode of delivery being DOT administered by the study staff at a central location
  • Intervention by arms: Malaria elimination with DP + PQ (intervention) vs no chemo-elimination (control) 
  • Concomitant interventions: Community engagement, improved case management, vector control strategies, participants received non-monetary incentives such as sweets and rice.
  • Target & size population: 2 villages control and 2 villages intervention. 
  • Inclusion criteria: Age ≥6 months, male or female
  • Exclusion criteria: Pregnant or lactating women, anyone with acute health problems 
  • Time of follow-up: 24 months
  • Clinicaltrial.gov ID: NCT01872702
Study Design

Type: Interventional
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Primary purpose: Treatment