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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT01434758
Eligibility Criteria:
Inclusion Criteria:
* Aged 0-15, presenting at NHP;
* Unexplained fever for more than 2 weeks; and
* Any form of TB suspected based on at least two of the following findings:
* unexplained cough for more than 2 weeks
* radiographic findings suggestive of tuberculosis.
* failure to thrive/weight loss
* enlarged non-tender lymph nodes or lymph node abscess, especially of the neck
* signs of meningitis with prodromal stage of at least one week
* HIV positive
* malnourished
* TB contact history
* Clinical judgment treating doctor.
* Relevant material (sputum or gastric aspirate, blood, and urine) available for microbiological diagnosis.
* Informed consent obtained from the patient's legal guardian(s).
Exclusion Criteria:
* Age \>15 years
* Diagnosed or treated for TB in the past year, received drugs effective against TB in last 3 months.
* Clinical contra-indications to collect the required study specimens
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
15 Years
Study:
NCT01434758
Study Brief:
Protocol Section:
NCT01434758