NCT06392152

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

G6PD Deficiency Prevalence and Targeted Elimination of Residual Plasmodium Vivax Hypnozoites in Community: Township Level Implementation in Banmauk and Moe Mauk, Myanmar

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,208 (actual)
• Sponsor: Pyae Linn Aung · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-03-31
• Completion: 2024-12-31
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

1 site across 1 country: Burma