Status:
COMPLETED
Postpartum Primaquine in Breast Milk
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Mahidol Oxford Tropical Medicine Research Unit
Conditions:
Postpartum Women
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Plasmodium vivax and ovale infections both follow chronically relapsing courses, leading to cumulative morbidity and mortality. P. vivax is the second most common malaria worldwide, with an estimated ...
Detailed Description
This is a prospective open-label, single site, dense pharmacokinetic study of primaquine (0.5 mg/kg daily for 14 days) taken by postpartum lactating women. The study will take place the Shoklo Malari...
Eligibility Criteria
Inclusion
- Mothers
- Lactating woman \>= 18 years old
- Planning to breastfeed for the duration of the study
- Breastfeeding one infant 48 hours - 5 days old
- Willingness and ability to comply with the study protocol for the duration of the study
- Can understand information about the study and provide consent
- Infants
- • Healthy neonate 48 hours - 5 days old
Exclusion
- Mothers
- Known hypersensitivity to Primaquine (PMQ), defined as history of erythroderma/other severe cutaneous reaction, angioedema or anaphylaxis
- Known Glucose-6-phosphate-dehydrogenase (G6PD) deficiency in mother defined as G6PD activity \<70% of normal male population median by spectrophotometry
- Presence of any condition which in the judgement of the investigator would place the participant at undue risk or interfere with the results of the study
- Screening Hct \<33% by complete blood count (CBC)
- Known history of severe jaundice in a previous child
- Blood transfusion within the 3 months before screening
Key Trial Info
Start Date :
July 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06191458
Start Date
July 9 2024
End Date
February 23 2025
Last Update
June 10 2025
Active Locations (1)
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1
Shoklo Malaria Research Unit (SMRU)
Mae Ramat, Changwat Tak, Thailand, 63140