Using Primaquine in Breastfeeding Women to Treat Malaria
Neonatal Exposure to Primaquine Through Breast Milk During Treatment in Postpartum Women
This study is testing if the malaria drug primaquine is safe and effective for breastfeeding mothers with newborns aged 48 hours to 5 days.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Mae Ramat, Tak) |
| Trial ID | NCT06191458 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of primaquine, an antimalarial medication, in postpartum lactating women. It aims to assess the safety and effectiveness of administering primaquine to mothers who are breastfeeding infants aged 48 hours to 5 days. The study will involve close monitoring of both mothers and their neonates for any adverse effects over a 28-day follow-up period. Participants will be screened for G6PD deficiency to ensure safety during treatment.
Who should consider this trial
Good fit: Ideal candidates include lactating women aged 18 and older who are breastfeeding a healthy infant aged 48 hours to 5 days and have a history of P. vivax infection.
Not a fit: Patients with known G6PD deficiency or those with a history of severe reactions to primaquine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe treatment option for postpartum women with P. vivax malaria, reducing the risk of relapse and improving maternal and infant health.
How similar studies have performed: While primaquine has been used for decades, this specific approach in postpartum lactating women is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Inclusion Criteria: Infants • Healthy neonate 48 hours - 5 days old Exclusion Criteria: 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 Exclusion Criteria: Infants * Known Glucose-6-phosphate-dehydrogenase (G6PD) deficiency in neonate 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 \<40% by CBC * Estimated gestational age at birth \< 38 weeks * Evidence of birth asphyxia (5 min Apgar score \<7) * Moderate or severe jaundice as defined as total serum bilirubin above treatment line on day 1 (before maternal dose)
Where this trial is running
Mae Ramat, Tak
- Shoklo Malaria Research Unit (SMRU) — Mae Ramat, Tak, Thailand (Recruiting)
Study contacts
- Principal investigator: Rose McGready, Ph.D — Shoklo Malaria Research Unit (SMRU)
- Study coordinator: Mary Ellen Gilder, MD
- Email: mellie@shoklo-unit.com
- Phone: +66 (0) 92 398 5849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.