Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru

NCT05361486 | Completed

• 1 other identifier: MMV_TQ_21_01
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the operational feasibility of using a new treatment algorithm for Malaria Vivax in Peru. The implementation package includes the following interventions:

• A revised vivax treatment algorithm that incorporates new Radical Cure tools (G6PD test + Tafenoquine or Primaquine)
• The training of Health Care Providers ( HCPs) in the revised algorithm and the use of the new RC tools
• Patient counselling
• A follow-up visit at Day 3 \[+2 days\] for patients after treatment start
• Accompanying supporting measures: job aids, strengthening of supervision and PV processes

Conditions

Malaria, Vivax

Keywords

Feasibility study, Tafenoquine, G6PD Testing

Outcome Measures

Primary Outcomes (1)

• To assess health care provider (HCP) compliance to a revised case management algorithm for vivax malaria that involves providing radical cure (RC) after G6PD testing and a follow-up visit on day 3 days [+ 2 days])

  Percentage of patients that were correctly treated with RC \[chloroquine (CQ) plus either primaquine (PQ) or tafenoquine (TQ)\] based on the revised algorithm

  Time from Malaria Vivax diagnosis until FU visit 3 days [+ 2 days]

Study Arms (1)

Patients

Patients with confirmation of vivax, attending one of the study facilities All patients aged 6 months onward, who have a confirmed P. vivax infection and who are in a study HF were approached to participate in the study.

Drug: Tafenoquine (TQ)

Interventions

Tafenoquine (TQ) DRUG

G6PD test after Malaria Vivax diagnosis

Also known as: SD Biosensor Test

Patients

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* All Health Care Providers (HCPs) working in the selected facilities who are involved in the management of vivax patients * All patients aged 6 months onward, who have a confirmed P. vivax infection and who are treated in a Health Facility participating in the study.

You may qualify if:

• All HCPs working in the selected facilities who are involved in the management of vivax patients.
• All patients aged 6 months onward, who have a confirmed P. vivax infection and who are treated in a study Health Facilities
• Pregnant and lactating women, who have a contra-indication to both Primaquine and Tafenoquine, but for whom correct case management will be evaluated as part of the primary endpoints.
• Patients providing informed consent and/or informed assent

You may not qualify if:

• Patients with signs of severe infection

Sponsors & Collaborators

• Medicines for Malaria Venture: lead
• UNITAID: collaborator
• Universidad Peruana Cayetano Heredia: collaborator
• ICON plc: collaborator

Study Sites (1)

Nauta Nucleo- Base

Nauta, Loreto, 16310, Peru

Location

Related Publications (7)

• Llanos-Cuentas A, Lacerda MV, Rueangweerayut R, Krudsood S, Gupta SK, Kochar SK, Arthur P, Chuenchom N, Mohrle JJ, Duparc S, Ugwuegbulam C, Kleim JP, Carter N, Green JA, Kellam L. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study. Lancet. 2014 Mar 22;383(9922):1049-58. doi: 10.1016/S0140-6736(13)62568-4. Epub 2013 Dec 19.

  PMID: 24360369 BACKGROUND

• Anderle A, Bancone G, Domingo GJ, Gerth-Guyette E, Pal S, Satyagraha AW. Point-of-Care Testing for G6PD Deficiency: Opportunities for Screening. Int J Neonatal Screen. 2018;4(4):34. doi: 10.3390/ijns4040034. Epub 2018 Nov 19.

  PMID: 31709308 BACKGROUND

• Chu CS, Bancone G, Kelley M, Advani N, Domingo GJ, Cutiongo-de la Paz EM, van der Merwe N, Cohen J, Gerth-Guyette E. Optimizing G6PD testing for Plasmodium vivax case management and beyond: why sex, counseling, and community engagement matter. Wellcome Open Res. 2020 Aug 25;5:21. doi: 10.12688/wellcomeopenres.15700.2. eCollection 2020.

  PMID: 32766454 BACKGROUND

• Commons RJ, Simpson JA, Watson J, White NJ, Price RN. Estimating the Proportion of Plasmodium vivax Recurrences Caused by Relapse: A Systematic Review and Meta-Analysis. Am J Trop Med Hyg. 2020 Sep;103(3):1094-1099. doi: 10.4269/ajtmh.20-0186.

  PMID: 32524950 BACKGROUND

• Domingo GJ, Advani N, Satyagraha AW, Sibley CH, Rowley E, Kalnoky M, Cohen J, Parker M, Kelley M. Addressing the gender-knowledge gap in glucose-6-phosphate dehydrogenase deficiency: challenges and opportunities. Int Health. 2019 Jan 1;11(1):7-14. doi: 10.1093/inthealth/ihy060.

  PMID: 30184203 BACKGROUND

• Douglas NM, Poespoprodjo JR, Patriani D, Malloy MJ, Kenangalem E, Sugiarto P, Simpson JA, Soenarto Y, Anstey NM, Price RN. Unsupervised primaquine for the treatment of Plasmodium vivax malaria relapses in southern Papua: A hospital-based cohort study. PLoS Med. 2017 Aug 29;14(8):e1002379. doi: 10.1371/journal.pmed.1002379. eCollection 2017 Aug.

  PMID: 28850568 BACKGROUND

• Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ. 1999 May 22;318(7195):1407-9. doi: 10.1136/bmj.318.7195.1407. No abstract available.

  PMID: 10334756 BACKGROUND

MeSH Terms

Conditions

Malaria, Vivax

Interventions

tafenoquine

Condition Hierarchy (Ancestors)

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

Study Officials

• Elmer Alejandro Llanos Cuentas, MD, PhD

  Universidad Peruana Cayetano Heredia (UPCH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: August 28, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

PE (1)