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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01177657
Eligibility Criteria:
Inclusion Criteria:
For cases:
* A male or female child born after 6 March 2006 and at least 12 weeks of age.
* Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.
* Onset of severe gastroenteritis ≤ 14 days prior to admission.
* Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.
* Written informed consent obtained from the parent or guardian of the subject.
For controls:
* Admitted for non-gastroenteritis causes at the same clinic/hospital as the case.
* Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians.
* Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks.
* Written informed consent obtained from the parent or guardian of the child.
Exclusion Criteria:
For cases:
* Subject has previously participated as case or control in this study.
* Onset of severe gastroenteritis \> 48 hours after admission to the hospital (nosocomial infections).
For controls:
* For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian.
* Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
* Child has participated in the past as a case or control in this study.
* Child living in the same house as the case
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Weeks
Study:
NCT01177657
Study Brief:
Protocol Section:
NCT01177657