Health Condition 1: B509- Plasmodium falciparum malaria, unspecified
Conditions
Interventions
Intervention1: Single dose of 0.25 mg/kg primaquine, i.e. 15 mg Tablet: Single dose on day 1, per oral administration
Control Intervention1: Single dose of 0.75 mg/kg Primaquine: Single dose on day 2,
Sponsors
ICMR National Institute of Malaria Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients with fever or history of fever in last 24 hours, P. falciparum mono-infection,
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients with G6PD activity,less than 4.0 U per g Hb as assessed by SD Biosensor, a Point of care device for G6PD assessment. Pregnant or breast-feeding females Hemoglobin less than 8 g per dl History of blood transfusion within last 3 months Known allergy to study medication Any sign of severe malaria Any comorbidity requiring inpatient management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of days for gametocyte clearance in both the arms. 2.Proportion of patients with gametocytes on day 3, 7, 14, and 28 in both the arms. 3.Gametocyte density on day 3, day 7, and day 14. 4.Mean difference in Hb between day 1 and day 3, day 1 and day 7 in both the arms. 5.Patients with more than 25 percent drop in Hb in both the arms. Timepoint: Day 1, 3, 7, 10, 14, 21, and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics of high-dose primaquine and low-dose primaquine in a subsample.Timepoint: First 24 hours after Primaquine administration | — |
Countries
India
Contacts
Public ContactDr Nitika
ICMR-NIMR
Outcome results
None listed