Clinical trial

Short Course Radical Cure of P.Vivax in Nepal- a Randomized Controlled Trial

Name

SIRIN

Description

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-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Trial arms

Trial start

2021-10-27

Estimated PCD

2024-03-31

Trial end

2024-03-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

primaquine

Primaquine regimen over 7 days (0.5mg/kg/day for 7 days)

Arms:

(P.f), (P.v)

Other names:

Jasoprim, Malirid, Neo-Quipenyl, Pimaquin, Pmq, Primachina, Primacin, Primaquina, Primaquine, Primaquine diphosphate, Primaquine Phosphate, and Remaquin

Size

100

Primary endpoint

Incidence Risk of P. vivax relapse at month 6

6 months

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-03-13

1 organization

1 product

2 indications

Organization

Menzies School of Health Research

Product

primaquine

Indication

Malaria

Indication

Vivax