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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT00401934
Eligibility Criteria:
Inclusion Criteria:
All Participants:
* Men or women age 2 to 60 years, inclusive.
* Provision of informed consent for enrollment in study by patient/parent or guardian, as well as verbal assent for children age 7 to 17 years, inclusive.
* Expressed interest and availability to fulfill the study requirements (index patients for up to 1 year; household contacts up to 30 days).
Index Patients:
\- Any individual with cholera enrolled in the surveillance system at the International Centre for Diarrhoeal Diseases Research, Bangladesh (ICDDR,B).
Household Contacts:
\- Any household contact of the index patient (defined as sharing the same cooking pot for longer than 3 days before the index patient presented to the ICDDR,B).
There is no upper limit on the number of household members that can enroll from a single household.
Exclusion Criteria:
* Clinically apparent severe comorbid condition (meningitis, encephalitis, coma, respiratory distress).
* Concurrent enrollment in an unrelated interventional study.
* For household contacts, living in the same place with an index patient for 3 or fewer days before the index patient presented to the International Centre for Diarrhoeal Diseases Research, Bangladesh.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
60 Years
Study:
NCT00401934
Study Brief:
Protocol Section:
NCT00401934