An interventional study of Focal Mass Drug Administration with Primaquine in Malaria, Mass Drug Administration and Myanmar, sponsored by Pyae Linn Aung. Active, not recruiting at 1 site in Myanmar. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Pyae Linn Aung · Not applicable, Interventional, and Treatment
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.
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.
123 studies on the registry are indexed under Malaria, Vivax; 19 are open to participants now.
This study's enrollment of 1,208 is above the median of 150 across 103 interventional studies indexed under Malaria, Vivax.
Browse Malaria, Vivax studies →This is the only study on the registry with Pyae Linn Aung as lead sponsor.
Compared within Malaria, Vivax, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Malaria. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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.
Time frame: 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.
Time frame: upto 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Mar 2024, 56 months.
Of 14 interventional studies with no phase under Malaria, Vivax, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's 56 months is above that.
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This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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