Short Course Radical Cure of P. Vivax Malaria in Nepal

NCT04079621 | Completed Phase 4 DMC

• 1 other identifier: SIRIN
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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

Conditions

Malaria; Malaria, Vivax; Malaria,Falciparum

Outcome Measures

Primary Outcomes (1)

• Incidence Risk of P. vivax relapse at month 6

  The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax and P. falciparum infection.

  6 months

Secondary Outcomes (5)

• The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax

  6 months

• The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. falciparum

  6 month

• The incidence risk of symptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection

  Day 28

• The incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection

  Day 28

• The incidence risk of asymptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection

  Day 28

Other Outcomes (6)

• The proportion of patients vomiting their medication within 1 hour of administration

  1 h

• The proportion of patients vomiting any of their PQ doses during the supervised course

  7 - 14days

• The proportion of adverse events and serious adverse events

  6 month

Study Arms (4)

(P.f)

EXPERIMENTAL

patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days plus a low dose course of primaquine (PQ) (3.5mg/kg total dose) given 7 days during schizontocidal treatment

Drug: primaquine

(P.v)

EXPERIMENTAL

patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (3.5mg/kg total dose) given over 7 days during schizontocidal treatment.

Drug: primaquine

Standard care (P.f)

NO INTERVENTION

patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days (plus a single dose PQ)

Standard care (P.v)

NO INTERVENTION

patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (total dose 3.5mg/kg) over 14 days

Interventions

primaquine DRUG

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

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

(P.f); (P.v)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menzies School of Health Research: lead
• Tribhuvan University, Nepal: collaborator

Study Sites (2)

Malakheti Hospital

Malakheti, Nepal

Location

Tikapur Hospital

Ṭikāpur, Nepal

Location

MeSH Terms

Conditions

Malaria; Malaria, Vivax; Malaria, Falciparum

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kamala Ley-Thriemer, MD, PhD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 27, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: The data are available for access via the WorldWide Antimalarial Resistance Network (WWARN.org). Requests for access will be reviewed by a Data Access Committee to ensure that use of data protects the interests of the participants and researchers according to the terms of ethics approval and principles of equitable data sharing. Requests can be submitted by email to malariaDAC@iddo.org via the Data Access Form available at WWARN.org/accessing-data. The WWARN is registered with the Registry of Research Data Repositories (re3data.org).

Locations

NE (2)