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

Pyae Linn Aung

Status: Active, not recruiting

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

Treatments: Drug: Focal Mass Drug Administration with Primaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT06392152

MHNO-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,208 patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,208 participants in 2 patient groups

TPT Group

Experimental group

Description:

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.

Treatment:

Drug: Focal Mass Drug Administration with Primaquine

Non-TPT

No Intervention group

Description:

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.