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 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT01082718
Eligibility Criteria:
Inclusion Criteria:
1. Cases: Pregnant women, age ≥18 years, in 2nd or 3rd trimester (gestational age ≥12 weeks determined by LMP and confirmed by fundal height measurement) Controls: Non-pregnant women ≥18 years old (negative urine pregnancy test)
2. Presence of P. falciparum ≤ 50,000 parasites/microliter
3. Fever (≥37.5C) or history of fever in preceding 48 hours
4. Willing to sign or thumb print informed consent
5. Willing to be hospitalized for 3 days and to return for scheduled follow up visits for treatment and observation until delivery
6. Willing to deliver in health facility
Exclusion Criteria:
1. Pregnancy \< 12 weeks
2. Presence of malaria species other than P. falciparum on the slide (P. vivax, P. malariae, or P. ovale, or mixed infection (P. falciparum in combination with any other malaria species)
3. History of allergy or hypersensitivity to interventional drugs
4. Exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman.
5. Patients taking drugs with possible interaction with study drugs (ie, digoxin or warfarin)
6. History or family history of epilepsy or psychiatric disorder
7. Presence of signs and symptoms of severe malaria
8. 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, but not the follow-up for drug efficacy.
9. History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, AIDS (HIV itself will not be an exclusion, but anyone with AIDS or HIV requiring HAART will be excluded), hemoglobinopathy,
10. Participant's inability to return for follow up visits
11. Age \<18 years
12. Hb\<8g/dl
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01082718
Study Brief:
Protocol Section:
NCT01082718