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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT00511004
Eligibility Criteria:
* INCLUSION CRITERIA:
Inclusion Criteria for Screening:
* Age 18 years to 55 years inclusive
* Both genders
* Not pregnant or breastfeeding by history
* If selected, subjects must be willing to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India
* If selected, subjects must be willing to undergo nighttime blood draws once every 6 months and Doppler ultrasound twice yearly for 2 years
* If selected, agree to have blood stored for future studies
* Ability to understand and give informed consent
Inclusion Criteria for Treatment:
* Age 18 to 55 years inclusive
* Men and non-pregnant or non-breast feeding women
* Microfilarial levels greater than 50mf/mL
* Willingness to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India every 6 months for 2 years
* Willingness to undergo nighttime blood draws once every 6 months for 2 years
* Ability to understand and give informed consent
* Hemaglobin (Hgb) levels for inclusion greater than 9 g/dL
* Creatinine (Cr) less than or equal to 1.2 mg/dL
* Alanine aminotransferase (ALT) less than 30 U/L
* Willingness to have blood stored for future studies
EXCLUSION CRITERIA:
Exclusion Criteria for Screening:
* Age less than 18 years or greater than 55 years
* Pregnant or breast feeding by history
Exclusion Criteria for Treatment:
* Non-volunteers
* Age less than 18 years or greater than 55 years
* Pregnant or breast feeding
* Hgb levels less than or equal to 9 g/dL
* Cr greater than 1.3 mg/dL
* ALT greater than 30 U/L
* Alcohol consumption of more than 2 beers or other alcohol-containing drinks/day within a week of each drug administration
* Temperature greater than 37.5 degrees Celsius
* Serious medical illness
* History of benzimidazole allergy
* History of DEC allergy
* Use of albendazole or DEC within past 6 months
* Unwillingness to comply with required study visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00511004
Study Brief:
Protocol Section:
NCT00511004