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:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT04984759
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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT04984759
Study Brief:
Protocol Section:
NCT04984759