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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01775592
Eligibility Criteria:
Inclusion Criteria:
* Age: from 6 months of age;
* Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
* Mono-infection with P.falciparum with parasite density between 500-100,000/µl
* Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.
Exclusion Criteria:
* Mixed malaria infection;
* Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
* Concomitant acute illness necessitating specific treatment (antibiotics);
* Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
* Severe malnutrition;
* Danger signs:
* not able to drink
* incontrollable vomiting
* recent history of convulsions (\>1 in 24 hours)
* unconscious state; neurological impairment
* unable to sit or stand
* Signs of severe malaria:
1. Cerebral malaria (unrousable coma)
2. Severe anaemia (Htc\< 15%)
3. Renal failure (serum creatinine \> 3 mg/dL)
4. Pulmonary oedema;
5. Hypoglycemia (\<40mg/dL)
6. Shock (systolic BP \< 70 mmHg in adults, 50 in children)
7. Spontaneous bleeding
8. Repeat generalized convulsions
9. Macroscopic haemoglobinuria
10. Severe jaundice
* Persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Study:
NCT01775592
Study Brief:
Protocol Section:
NCT01775592