Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas

NCT03916003 | Completed Phase 4 DMC

• 1 other identifier: 19-3288
• Study Type: interventional
• Target: 500
• Locations: 3 countries
• Sites: 3

Brief Summary

This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.

Conditions

Malaria; Vivax Malaria; Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

• Incidence risk of any P. vivax parasitaemia at day 63

  The incidence risk of any P. vivax parasitaemia at day 63

  63 days

Secondary Outcomes (12)

• Incidence risk of symptomatic P. vivax parasitaemia at day 63

  63 days

• Incidence risk of all any P. vivax parasitaemia at day 28 and 42

  28 and 42 days

• Incidence risk of any P. falciparum malaria at day 28, 42 and 63

  28/42/63 days

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

  1 hour

• proportion of patients vomiting any of their PQ doses within 1 hour of administration

  7 days

Study Arms (2)

PQ7

EXPERIMENTAL

high dose primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)

Drug: primaquine

standard care

NO INTERVENTION

As per national guidelines for P. falciparum treatment

Interventions

primaquine DRUG

Primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)

PQ7

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 mono-infection
• Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
• Age \>1 years (≥ 18 years at the Ethiopia site)
• G6PD normal as defined by the Biosensor (SD Biosensor, ROK) at ≥70% of the adjusted male median (AMM) for each site
• 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
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Tribhuvan University, Nepal: collaborator
• Arba Minch University: collaborator
• Addis Ababa University: collaborator

Study Sites (3)

Icddrb

Upazila, Bangladesh

Location

Arba Minch University

Arba Minch, Ethiopia

Location

Puskesmas Mangili

Dusun Tenggara, Indonesia

Location

Related Publications (2)

• Thriemer K, Degaga TS, Christian M, Alam MS, Rajasekhar M, Ley B, Hossain MS, Kibria MG, Tego TT, Abate DT, Weston S, Mnjala H, Rumaseb A, Satyagraha AW, Sadhewa A, Panggalo LV, Ekawati LL, Lee G, Anose RT, Kiros FG, Simpson JA, Karahalios A, Woyessa A, Baird JK, Sutanto I, Hailu A, Price RN. Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial. Lancet. 2023 Dec 2;402(10417):2101-2110. doi: 10.1016/S0140-6736(23)01553-2. Epub 2023 Nov 15.

  PMID: 37979594 DERIVED

• Thriemer K, Degaga TS, Christian M, Alam MS, Ley B, Hossain MS, Kibria MG, Tego TT, Abate DT, Weston S, Karahalios A, Rajasekhar M, Simpson JA, Rumaseb A, Mnjala H, Lee G, Anose RT, Kidane FG, Woyessa A, Baird K, Sutanto I, Hailu A, Price RN. Reducing the risk of Plasmodium vivax after falciparum infections in co-endemic areas-a randomized controlled trial (PRIMA). Trials. 2022 May 18;23(1):416. doi: 10.1186/s13063-022-06364-z.

  PMID: 35585641 DERIVED

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 Thriemer, MD

  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: April 12, 2019
• First Posted: April 16, 2019
• Study Start: August 18, 2019
• Primary Completion: May 14, 2022
• Study Completion: July 30, 2022
• Last Updated: November 21, 2023

Record last verified: 2023-11

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

ID (1); ET (1); BA (1)