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 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT00701961
Eligibility Criteria:
Inclusion Criteria:
1. Plasmodium falciparum monoinfection (any density)
2. At least 18 years old;
3. Haemoglobin at leats 7 g/dL;
4. Residence within the health facility catchment's area;
5. Willing to adhere to the study requirements
6. Willing to deliver in health facility
7. Ability to provide written informed consent
8. EITHER pregnant women in the 2nd or 3rd trimester (cases)or non-pregnant women between the ages of 18 and 49 years (controls).
Exclusion Criteria:
1. Pregnancy 1st trimester
2. History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
3. Known major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
4. Current cotrimoxazole prophylaxis or ARV treatment;
5. Any significant presenting illness that requires hospitalization, including severe malaria;
6. Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
7. Prior enrollment in the study or concurrent enrollment in another study.
8. Unable to take oral medication
9. Clear evidence of treatment with antimicrobials with antimalarial activity (erythromycin or other macrolides, co-trimoxazole or other sulfonamides, any tetracycline including doxycycline, quinolones and clindamycin) or exposure to antimalarial drugs within the week prior enrollment.
10. History of allergy or hypersensivity to interventional drugs
11. Patients taking drugs with possible interaction with study drugs (i.e. digoxin or warfarin)
12. History or family history of epilepsy or psychiatric disorder
13. Presence of signs and symptoms of severe malaria
14. Inability to tolerate oral medication (repeated vomiting, impairment of consciousness). Vomiting of any of the treatment doses will lead to exclusion from the pharmacokinetic sampling.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT00701961
Study Brief:
Protocol Section:
NCT00701961