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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT00298233
Eligibility Criteria:
Inclusion Criteria:
* At least one of the following respiratory symptoms: cough, dyspnea, sore throat
* Evidence of severe influenza or avian influenza, as defined below
* Severe influenza infection criteria:
1. Need for hospitalization
2. One of the following:
1. New infiltrate on chest x-ray (or any infiltrate if no prior chest x-ray or not known)
2. Severe tachypnea (more information on this criterion can be found in the protocol)
3. Severe dyspnea
4. Arterial oxygen saturation of 92% or less on room air by trans-cutaneous method
3. Positive diagnostic testing for influenza, as defined by either rapid influenza antigen (Ag) positive (A or B) or qualitative reverse transcriptase-polymerase chain reaction (RT-PCR) positive for any influenza
4. Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 10 days before study enrollment
* Avian influenza infection criteria:
1. Nasal wash, nasopharyngeal aspirate, endotracheal aspirate, nasal swab, or throat swab that is RT-PCR positive influenza for H5 influenza
2. Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 14 days before study enrollment
Exclusion Criteria:
* Received more than 72 hours of oseltamivir (six doses) within 14 days
* Received oseltamivir at higher than standard doses within the last 14 days or during current acute illness, whichever is longer
* History of allergy or severe intolerance of oseltamivir, as determined by the investigator
* Alternate explanation for the clinical findings, as determined by the investigator and with the information immediately available
* Creatine clearance less than 10 ml/minute
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT00298233
Study Brief:
Protocol Section:
NCT00298233