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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05232227
Eligibility Criteria:
Inclusion Criteria:
* Age ≥5 years
* Fever (T≥37.5 ⁰C, oral) and/or history of fever in the previous 48 hours
* P. vivax mono-infection
* Normal G6PD status using Biosensor™ (SD Bioline, ROK) (G6PD activity ≥ 70% of the adjusted male median (AMM))
* Written informed consent
* Living in the study area and willing to be followed for six months
Exclusion Criteria:
* Malaria treatment in the previous 30 days,
* Self-reported chronic disease (including severe cardiac, hepatic, or renal disorders, malnutrition, or HIV),
* Clinically significant concurrent illness,
* Use of medications known to interfere with the pharmacokinetics of PQ or CQ,
* Known hypersensitivity to any of the study drugs,
* Use of an investigational drug within the previous 30 days or five half-lives (whichever was longer),
* History of moderate or severe adverse reaction to any of the study drugs,
* Hemoglobin \< 7 g/dL,
* Pregnancy (by urine pregnancy test) or breastfeeding,
* Not able to take oral treatment,
* Signs of severe malaria:
* Unable to drink
* Vomiting (more than twice in the previous 24 hours)
* Recent history of convulsions (one or more in the previous 24 hours)
* Impaired consciousness
* Unable to sit or stand
* Cerebral malaria (unarousable coma)
* Severe anemia (hematocrit \<15% or clinical signs) hemoglobin \<5 mg/ml) (Note: we will use hemoglobin less than 7 mg/ml as exclusion criteria)
* Renal failure (serum creatinine \>3 mg/dL or clinical signs)
* Pulmonary edema
* Hypoglycemia (blood glucose \<40mg/dL or clinical signs)
* Shock (systolic blood pressure \<70 mm Hg in adults; 50 mm Hg in children)
* Spontaneous bleeding/disseminated intravascular coagulation.
* Repeated generalized convulsions
* Acidemia/acidosis (clinical signs)
* Macroscopic hemoglobinuria
* Jaundice●
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
65 Years
Study:
NCT05232227
Study Brief:
Protocol Section:
NCT05232227