EUCTR2005-005239-80-GB
Active, not recruiting
Phase 1
Prospective study to assess the emergence of drug resistance to oseltamivir following treatment of acute influenza A among children - Oseltamivir resistance study
niversity Hospitals Leicester, Leicester General Hospital0 sites100 target enrollmentDecember 2, 2005
ConditionsInfluenza A
Drugstamiflu suspension
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza A
- Sponsor
- niversity Hospitals Leicester, Leicester General Hospital
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •Boys and girls must satisfy the following to qualify for the study:
- •1\. Aged between \>1 and 12 years
- •2\. Parents or legal guardians willing to give written informed consent
- •3\. Presenting within 48 hours of onset of an acute febrile illness including acute respiratory tract illness, febrile seizure, febrile gastrointestinal illness, acute febrile illness with temp \>38oC
- •4\. Willing for post treatment sampling to be conducted
- •5\. Able to adhere with oseltamivir treatment (5 days b.d dosing with paediatric suspension)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
Exclusion Criteria
- •Exclusion criteria
- •1\. unable to obtain informed consent
- •2\. conditions presenting with: rash, known bacterial aetiology, non\-respiratory conditions with known aetiology, allergy to oseltamivir
- •3\. presence of underlying condition requiring dose alteration of oseltamivir e.g. severe renal failure
- •4\. Concomitant therapy requiring oseltamivir dose alteration including methotrexate and probenecid
- •5\. inability to obtain nasopharyngeal sample for analysis
- •6\. concurrent enrollment in any therapeutic intervention studies
Outcomes
Primary Outcomes
Not specified
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