Neonatal Exposure to Primaquine Through Breast Milk During Treatment in Postpartum Women

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 13.8 million cases annually, and there is increasing concern about severe illness and death in vulnerable populations. Radical cure of P.vivax and P.ovale with 8-aminoquinolines is necessary to prevent relapse. The most widely 8-aminoquinoline is primaquine (7-14 day course), which has been used for almost 75 years. Its widespread use is hampered by the potentially severe haemolysis primaquine may trigger in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, the most common red blood cell enzyme deficiency in the world. Safe administration of primaquine requires at least 30% of normal G6PD activity to avoid significant hemolysis. Screening for malaria is routine in pregnancy, leading to improved detection of P. vivax infections, but primaquine and is contraindicated in pregnancy. As a result, relapses of P. vivax are common in postpartum and lactating women. Normal G6PD activity levels in infants less than 6 months old have only recently been described and have only been established along the Thailand-Myanmar border. Most low-resource settings are therefore unable to determine infant G6PD status. Uncertainty about infant G6PD status means that breastfeeding women are rarely offered radical cure because of theoretical concerns about drug exposure through breast milk triggering haemolysis in breastfed infants and children with G6PD deficiency. Though neonates generally have higher G6PD activity than adults, increased haemolysis for a neonate could theoretically contribute to neonatal jaundice and anaemia. Understanding drug exposure to a breastfeeding neonate is operationally important, as interventions that can be safely offered before women leave the hospital postpartum have higher uptake. Current World Health Organization guidelines advise against prescribing primaquine to lactating women if they are breastfeeding infants less than 6 months old, or breastfeeding infants with G6PD deficiency or unknown G6PD status.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

⁃ • Healthy neonate 48 hours - 5 days old

Locations
Other Locations
Thailand
Shoklo Malaria Research Unit (SMRU)
Mae Ramat
Time Frame
Start Date: 2024-07-09
Completion Date: 2025-02-23
Participants
Target number of participants: 12
Treatments
Experimental: Primaquine
Twelve healthy postpartum women who are breast feeding healthy neonates 48 hours - 5 days old will receive primaquine 0.5 mg/kg once daily for 14 days.
Sponsors
Leads: University of Oxford
Collaborators: Mahidol Oxford Tropical Medicine Research Unit

This content was sourced from clinicaltrials.gov