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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT00979667
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients 18 years or older with body weight \>40kg
* Written informed consent
* Presented within 48 hours of onset of influenza-like illness
* Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:
* Clinical criteria
* Fever \>38 oC (Infrared Forehead Thermometer will be used to measure the Temporal Artery Temperature under the skin) AND
* At least one upper respiratory tract infection (cough, running nose, sore throat)
* Laboratory criteria Positive rapid test result for influenza A (by Influenza Rapid Diagnostic test) within 48 hours of onset of flu-like symptoms
Exclusion Criteria:
* Age below 18 years
* Persons who lack the ability to care for themselves
* Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
* Pregnancy or lactation
* Coexisting liver disease
* Coexisting cardiovascular disease except stable hypertension without complication
* Coexisting chronic pulmonary disease
* Coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies
* Renal failure
* Terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months
* Known intolerance to oseltamivir or zanamivir
* Known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those
* Subjects who have received oseltamivir as prophylaxis for H1N1 infection
* Subjects who have received any investigational drug within 1 month prior to study entry
* Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00979667
Study Brief:
Protocol Section:
NCT00979667