Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria and mixed infection
Conditions
Interventions
Intervention1: AS+SP+PQ: AS: Oral, 4mg/kg, daily, on Day 0,1,2
SP: Oral, 25/1.25mg/kg, daily, on Day 0
PQ: Oral, 0.75mg/kg, daily, on Day 0
Intervention2: AS+SP+PQ: AS: Oral, 4mg/kg, daily, on Day 0,1
Sponsors
National Institute of Malaria Research New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Open enrollment of any uncomplicated PF patient regardless of the gametocyte status, including mixed infections. This provides a stronger trial design given the operational simplicity, fewer assumptions, and greater generalizability of results
Exclusion criteria
Exclusion criteria: Signs of severe malaria, history of previous antimalarial intake within < 1 week, children <1 year, and G6PD deficient patients will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome will be host gametocytemia. We will examine proportions at each time and survival curves in the proportion of patients who are gametocytemic (dichotomous) upto day 28.Timepoint: 28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes include adverse events, gametocyte density, primaquine safety (change in hct/hgb), crude and PCR adjusted cure rates. Pre-spectified sub-analyzes include between individual arms, age, and gametocytemia at presentation. Timepoint: Days 0,1,2,3,7,14,21,28 | — |
Countries
India
Contacts
Public ContactDr Anup Anvikar
National Institute of Malaria Research
Outcome results
None listed