Status:
COMPLETED
Short Course Radical Cure of P. Vivax Malaria in Nepal
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
Tribhuvan University, Nepal
Conditions:
Malaria
Malaria, Vivax
Eligibility:
All Genders
1+ years
Phase:
PHASE4
Brief Summary
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phos...
Detailed Description
Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febril...
Eligibility Criteria
Inclusion
- P. falciparum and/or vivax infection
- Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- Age \>1 years
- G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines
- Written informed consent
- Able to comply with all study procedures and timelines
Exclusion
- General danger signs or symptoms of severe malaria
- Anaemia, defined as Hb \<8g/dl
- Pregnant women as determined by Urine β-HCG pregnancy test
- Breast feeding women
- Known hypersensitivity to any of the drugs given
- Regular use of drugs with haemolytic potential
- Blood transfusion within the last 4 months
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04079621
Start Date
October 27 2021
End Date
March 31 2024
Last Update
August 29 2024
Active Locations (2)
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1
Malakheti Hospital
Malakheti, Nepal
2
Tikapur Hospital
Ṭikāpur, Nepal