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

NCT ID: NCT06392152

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

This study employed a cluster-randomized crossover design in which two groups of villages received TPT at different times. In August-September 2019, Group 1 received TPT (0.25 mg/kg/day primaquine base for 14 days), while Group 2 was the control. In June-July 2020, Group 2 received TPT, while Group 1 served as the control. To evaluate the effectiveness of TPT for preventing relapses of vivax malaria, two indicators were utilized: infection prevalence at 3-month intervals estimated through cross-sectional surveys and monthly malaria incidence by passive case detection. The data were analyzed using descriptive statistics, chi-squared test, cumulative hazard function, and mixed model logistic regression.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TPT Group

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.

Group Type: EXPERIMENTAL

Focal Mass Drug Administration with Primaquine

Intervention Type: 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.

Non-TPT

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Focal Mass Drug Administration with Primaquine

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.

Intervention Type: DRUG

Other Intervention Names

Focal MDA with PQ

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: collaborator

Pyae Linn Aung

OTHER

Sponsor Role: lead

Responsible Party

Pyae Linn Aung

Secretary

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Myat Phone Kyaw, PhD

Role: PRINCIPAL_INVESTIGATOR

Myanmar Health Network Organization

Locations

Myanmar Health Network Organization

Yangon, , Burma

Countries

Burma

References

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.

Reference Type: DERIVED

PMID: 40799786 (View on PubMed)

Other Identifiers

MHNO-002

Identifier Type: -

Identifier Source: org_study_id