Last Updated

24 Oct 2018

Assess the micro-epidemiology of resistant falciparum malaria in SE Asia and perform and evaluate an intervention with targeted chemo-elimination through a modified mass drug administration approach (Lao People's Democratic Republic)

Objectives

To conduct and evaluate the efficacy of pilot implementation of targeted chemo-elimination (modified mass drug administration approach) in selected areas with the goal of eliminating malaria. This strategy will be used to identify specific areas where mass treatment is necessary to eliminate all malaria parasites.

Specific objectives:

  1. Assess the safety and acceptability of TME to eliminate the sub-microscopic reservoir of P. falciparum in an area of artemisinin resistance
  2. Assess the feasibility of MDA with Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ)
  3. Assess the impact of MDA with DP + PQ 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 contributes 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 TME staff
  • Intervention by arms: Malaria elimination with DP + PQ (intervention) vs no chemo-elimination (control) 
  • Concomitant interventions: LLINs, community engagement activities and strengthening of village malaria worker networks. The participants were reimbursed for their travel and opportunity costs
  • 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: 12 months
  • Clinicaltrial.gov ID: NCT01872702
Study Design

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