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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT07060404
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years of age
2. Both mother and infant have G6PD activity \>70% (normal activity; SD Biosensor)
3. They have no significant co-morbidity
4. Delivered a live singleton baby within past 48-hours
5. Rapid diagnostic test negative for malaria
6. No history of hypersensitivity to 8-aminoquinoline drugs
7. Plan to exclusively breastfeed for at least two months
8. History of vivax malaria (as per health book)
9. They can attend follow-up assessments for the duration of the study
Exclusion Criteria:
1. Either mother/infant have G6PD activity \<70% (SD Biosensor)
2. Either mother/infant have significant co-morbidity
3. Mother did not deliver a live singleton within past 48-hours
4. Mother/infant are rapid diagnostic test positive for malaria
5. Mother has a history of hypersensitivity to 8-aminoquinoline drugs
6. Mother does not plan to exclusively breastfeed for at least two months
7. Mother does not have a history of vivax malaria (as per health book)
8. Cannot or are not willing to attend follow-up assessments for the duration of the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07060404
Study Brief:
Protocol Section:
NCT07060404