Efficacy of Focal Primaquine Mass Administration for Eliminating Plasmodium Vivax Malaria in Northern Myanmar

NCT06392152 | Active Not Recruiting DMC

• 1 other identifier: MHNO-002
• Study Type: interventional
• Target: 1,208
• Locations: 1 country
• Sites: 1

Brief Summary

Plasmodium vivax has become the predominant species in the Greater Mekong Subregion and is a major challenge for regional malaria elimination. Mass primaquine administration has played a decisive role in malaria elimination in many temperate zone countries, but its efficacy in tropical areas remains to be evaluated. This study aims to assess the efficacy of targeted primaquine mass treatment (TPT) for eliminating P. vivax malaria in northern Myanmar.

Conditions

Malaria; Mass Drug Administration; Myanmar; Plasmodium Vivax; Primaquine

Outcome Measures

Primary Outcomes (2)

• Infection prevalence at 3-month intervals estimated through cross-sectional surveys

  The primary outcome of the study was the reduction in the prevalence of infection in the study population in 3 and 6 months after the PQ MDA. Malaria prevalence was determined through cross-sectional surveys (CSSs) of the village populations one week before MDA to assess baseline infection prevalence and three and six months after the MDA. For each CSS, finger-prick blood was obtained from each participant to prepare two dried filter-paper blood spots (DBSs). DNA was extracted from the DBSs, and Plasmodium DNA was detected by nested PCR using species-specific primers. Per recommendations from the National Malaria Treatment Guidelines and because molecular detection was performed after the completion of the field studies, PCR-positive asymptomatic infections were not treated. Therefore, to determine malaria prevalence, six cross-sectional surveys were conducted, collecting blood samples from both groups at 3-month intervals between each round.

  upto 24 months

• Monthly malaria incidence by passive case detection

  The another outcome of the study was the incidence of clinical malaria within 6 months of PQ MDA. Clinical malaria cases were diagnosed using an RDT (SD BIOLINETM Malaria Ag P.f/P.v test) and recorded at either the villages by the Integrated Community Malaria Volunteers or the township hospital.

  upto 24 months

Study Arms (2)

TPT Group

EXPERIMENTAL

Based on the WHO malaria treatment guidelines, a standard PQ regimen of 0.25 mg PQ base/kg body weight daily for 14 days was administered to eligible individuals through directly observed treatment (DOT) to ensure drug intake and monitor potential adverse effects during August-September 2019. The safety of each participant was monitored by follow-up blood testing using Hemocue's hemoglobin photometers to track changes in hemoglobin levels.

Drug: Focal Mass Drug Administration with Primaquine

Non-TPT

NO INTERVENTION

To mitigate potential season effects, we included a crossover design to switch the two groups after nine months, when Group 2 (non-TPT) received focal PQ MDA in June-July 2020, while Group 1 served as control during this period.

Interventions

Focal Mass Drug Administration with Primaquine DRUG

A population census was conducted in each village in August 2019 to record the demographic information and malaria histories of the villagers. Vulnerable groups such as pregnant women, breastfeeding mothers, and children under 7 years were excluded from PQ administration. Both Group 1 \&2 underwent a preliminary clinical assessment to exclude individuals with G6PD deficiency and low hemoglobin levels. Based on the WHO malaria treatment guidelines, a standard PQ regimen of 0.25 mg PQ base/kg body weight daily for 14 days was administered through directly observed treatment (DOT) to ensure drug intake and monitor potential adverse effects. The safety of each participant was monitored by follow-up blood testing using Hemocue's hemoglobin photometers to track changes in hemoglobin levels. As per cross-over design, eligible individulas from Group-1 received PQ-MDA in year 1 and Group-2 received PR-MDA in the following year.

Also known as: Focal MDA with PQ

TPT Group

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents in study villages
• Male/ female
• Consent to participate

You may not qualify if:

• Low Hb%
• G6PD deficiency
• pregnant women,
• breastfeeding mothers and
• children under 7 years

Sponsors & Collaborators

• Pyae Linn Aung: lead
• University of South Florida: collaborator
• Mahidol University: collaborator

Study Sites (1)

Myanmar Health Network Organization

Yangon, 11091, Burma

Location

Related Publications (1)

• Aung PL, Soe MT, Soe TN, Zhao Y, Cao Y, Aung PP, Oo TL, Lawpoolsri S, Nguitragool W, Sattabongkot J, Kaewkungwal J, Kyaw MP, Parker DM, Cui L. Efficacy of Focal Primaquine Mass Administration for Eliminating Plasmodium vivax Malaria in Northern Myanmar: A Cluster-Randomized Trial. Open Forum Infect Dis. 2025 Aug 5;12(8):ofaf465. doi: 10.1093/ofid/ofaf465. eCollection 2025 Aug.

  PMID: 40799786 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Vivax

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

• Myat Phone Kyaw, PhD

  Myanmar Health Network Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Secretary

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 30, 2024
• Study Start: July 1, 2019
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)