Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT06191458
Eligibility 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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06191458
Study Brief:
Protocol Section:
NCT06191458