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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00408369
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 45 years
* BMI between 19 and 30 (Appendix IV)
* Able to provide home address and phone number; work description, address, and phone number; and to provide the name, address, and phone number of a person willing and able to assist the investigators in making contact with the cognate volunteer during the study period
* Able and willing to follow-up intensively for 3 months of scheduled visits
* Post-menopausal or surgically sterilized women
* Score of 80% or more on a written exam to test malaria knowledge and comprehension of the study
* Serum and red cells support growth of P. falciparum in vitro (Appendix V)
* Blood type A or O
* Able and willing to provide written informed consent for screening, HIV testing, and study participation-
Exclusion Criteria:
* Clinically significant abnormalities on screening examinations
* AST, ALT, bilirubin, hemoglobin, hematocrit, prothrombin time, partial thromboplastin time, or creatinine outside the limits of normal as defined at the time of testing by the Johns Hopkins Medical Laboratories
* laboratory evidence of HIV infection or active viral hepatitis
* G6PD deficiency, or hemoglobin S or C
* Significant medical illnesses requiring systemic treatment and/or hospitalization within one month of enrollment
* History of chronic medical illnesses, significant in the investigators' judgment
* Self-described use of tobacco
* History of alcohol or drug abuse
* Use of prescribed or over-the-counter medications or nutritional supplements within two weeks of enrollment (vitamins, at or below the daily recommended dose, may be taken during the study)
* Women of childbearing potential
* Blood or plasma donation within 2 weeks of enrollment
* History of malaria or residence in a malaria-endemic area
* Allergy to mosquito bites
* Intolerance to chloroquine, Malarone, quinine, quinidine, or tetracycline
* Taken anti-infective drugs or quinine-containing beverages in the week prior to enrollment
* Currently participating in other clinical trials, participated in a drug trial within two weeks of enrollment, or plan to participate in another clinical trial within three months from challenge
* Any factors for which the investigator believes that participation of the volunteer in the study is not appropriate
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00408369
Study Brief:
Protocol Section:
NCT00408369