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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT01546961
Eligibility Criteria:
Inclusion Criteria:
* Age 18-50 years
* Gestational age (ultrasound confirmed) \> 13.0 weeks
* Viable fetus as assessed by ultrasound scanning
* Microscopically confirmed uncomplicated P.vivax malaria
* Willingness and ability to comply with the study protocol for the duration of the trial
* Written informed consent provided
* No signs of labour
Exclusion Criteria:
* Known hypersensitivity to chloroquine
* Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1
* Gastrointestinal dysfunction that could alter absorption or motility
* History or known liver diseases or other chronic diseases (excluding thalassaemia \& G6PD deficiency)
* Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study
* Splenectomy
* Hematocrit (HCT) \< 20% (based on field reading i.e. capillary sample)
* Taking contraindicated medications
* History of narcotic or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01546961
Study Brief:
Protocol Section:
NCT01546961