Tafenoquine and Primaquine in Colostrum and Breast Milk

Launched by UNIVERSITY OF OXFORD · Jul 28, 2021

Keywords

ClinConnect Summary

The study will take place at clinics of the Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit in Tak Province, Thailand. The clinics serve a population of migrant workers resident along the Thailand-Myanmar border. Non-pregnant breastfeeding women that access care at SMRU (postnatal care, outpatient, vaccine and routine baby care departments) will be invited to participate with their breastfed children.

All lactating women and their children will be G6PD phenotypically normal. Participants will be enrolled as follows; Arm 1: Primaquine mother-neonate pairs...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Mother
• • Lactating women \>= 16 years old who are breast feeding one child who fits the time window for the respective study arm
• • Planning to breastfeed for the duration of the study
• • Willingness and ability to comply with the study protocol for the duration of the study
• • Willingness to delay pregnancy until the end of the period of drug exposure (14 days for PMQ and 90 days for TQ)
• • Current pregnancy excluded by urine pregnancy test and ultrasound OR immediate postpartum status (≤2 months)
• • Can understand information about the study and provide consent
• • Children
• • Healthy children falling into the time window for the respective study arm
• • ≤ 5 days for Arms 1 \& 3
• • \> 14 days for Arm 2
• Exclusion Criteria:
• • Mothers
• • Known hypersensitivity to PMQ or TQ, 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
• • Alkaline phosphatase (ALT) \> 2x the upper limit of normal (ULN)
• • Pregnancy
• • Screening hematocrit (Hct) \<33%
• • Known history of severe jaundice in a previous child
• • Known history of psychiatric illness or abnormal depression screening score
• • Blood transfusion within the 3 months before screening
• • Children
• • Known hypersensitivity to primaquine or tafenoquine, defined as history of erythroderma/other severe cutaneous reaction, angioedema or anaphylaxis
• • Known Glucose-6-phosphate-dehydrogenase (G6PD) deficiency in child defined as G6PD activity \<70% of normal male population median by spectrophotometry in children
• • 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%
• • Estimated gestational age at birth \< 38 weeks
• • Blood transfusion within the 3 months before screening
• • 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)