Short Duration Primaquine over Current Regimen in Vivax Malaria

Safety and efficacy of a 7-day higher dose primaquine regimen over current regimen in vivax malaria: A randomized clinical trial from eastern India - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056355

Enrollment

252

Registered

2023-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B518- Plasmodium vivax malaria with other complications Health Condition 2: B519- Plasmodium vivax malaria without complication

Interventions

Intervention1: Primaquine 0.5mg/kg: Primaquine 0.5mg/kg (30mg OD) x 7 days PO Control Intervention1: Primaquine 0.25mg/kg: Primaquine 0.25mg/kg (15mg OD) x 14 days PO

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants over 18 years of age with informed consent 2. Participants over 15 years of age with assent from guardians 3. Monoinfection or mixed infection with P. vivax malaria 4. Diagnosis of malaria based either on rapid diagnostic test or slide microscopy 5. Able to comply with the study instructions and follow-up

Exclusion criteria

Exclusion criteria: 1. Female participants who are pregnant or lactating 2. Previous episode of hemolysis or severe hemoglobinuria following primaquine 3. Hemoglobin concentration less than 8 gm/dl 4. Blood transfusion in the last 90 days 5. Coadministration of other medication known to cause hemolysis 1. Female participants who are pregnant or lactating 2. Previous episode of hemolysis or severe hemoglobinuria following primaquine 3. Hemoglobin concentration less than 8 gm/dl 4. Blood transfusion in the last 90 days 5. Coadministration of other medication known to cause hemolysis

Design outcomes

Primary

Measure	Time frame
The primary outcome is symptomatic recurrence of vivax malaria. Participants will be assessed for signs and symptoms of vivax malaria following initiation of antimalarial treatment suggestive of recurrence. This will be done by history and physical examination on Days 0, 3, 7, 28, 42, 84, 168. Blood smear microscopy for parasitemia will be done on Days 0, 3, 7, 28, 42.Timepoint: Assessment will be done on Days 0, 3, 7, 28, 42, 84, 168.	—

Measure

Time frame

The primary outcome is symptomatic recurrence of vivax malaria. Participants will be assessed for signs and symptoms of vivax malaria following initiation of antimalarial treatment suggestive of recurrence. This will be done by history and physical examination on Days 0, 3, 7, 28, 42, 84, 168. Blood smear microscopy for parasitemia will be done on Days 0, 3, 7, 28, 42.Timepoint: Assessment will be done on Days 0, 3, 7, 28, 42, 84, 168.

—

Secondary

Measure	Time frame
Serious Adverse Drug reactions in both treatment armsTimepoint: 6 months of followup	—

Countries

India

Contacts

Public ContactChristy John

Institute of Post Graduate Medical Education and Research

jaggs.nbmc@gmail.com9035237747

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026