An unblinded randomized study of influenza A/H1N1 2009 (swine flu) resistance under standard and double dose oseltamivir treatment in participants with influenza

Phase 4

Recruiting

• Conditions: Influenza; Infection - Other infectious diseases

• Registration Number: ACTRN12610000004066
• Lead Sponsor: ational Centre for Immunisation Research and Surveillance (NCIRS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Participants must meet all of the following inclusion criteria to participate in this study:
1. The age of the patient is at least 5 years.
2. The patient has a positive rapid antigen test for influenza A and symptoms indicative of influenza that have lasted
no more than 48 hours:
- fever >= 37.8 celsius and
- at least one respiratory symptom (cough, coryza, sore throat, rhinitis)

Exclusion Criteria

If one or more of the following criteria are met, the participant will be ineligible to take part in this study:
1. Clinical suspicion of infection with a respiratory virus other than influenza.
2. Suspicion of invasive bacterial infection requiring immediate admission to hospital.
3. Evidence of a poorly controlled underlying medical condition.
4. Known immunosuppression (malignancy, transplant, drugs)
5. Pregnant or lactating females
6. Known allergy to oseltamivir.
7. Participation in another clinical trial with an investigational drug.
8. Participant with insufficient English language skills.
9. A person about whom the investigator thinks that the person is unlikely to comply with the study requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified