Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main purpose of this study is to assess the potential exposure of neonates to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmahungary Group
• Collaborator: Hoffmann-La Roche
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

1. The patient is breastfeeding, or has just given birth.

2. The age of the patient is at least 18 years.

3. Written Informed Consent obtained from the patient.

4. The patient has received a diagnosis of influenza based upon the following clinical symptoms, during a time when influenza is known to be circulating:

• fever ≥37.8oC at the time of examination or a history of fever and

• at least one respiratory symptom (cough, coryza, sore throat, rhinitis)

5. Confirmation of infection with influenza is not required for inclusion. As H1N1v infection in pregnancy and lactation is a dangerous condition, and recommendations are that clinicians should commence antiviral therapy on an empiric basis and not wait for the results for laboratory investigations. Therefore, this study will not undertake or require any virological investigations, although these will be recorded if undertaken as part of routine care.

Exclusion Criteria:

1. Clinical suspicion of infection with a respiratory virus other than influenza and a decision by the treating physician that treatment with oseltamivir is not indicated.

2. Suspicion of invasive bacterial infection requiring immediate admission to hospital.

3. Evidence of a poorly controlled underlying medical condition, with the specific understanding that pregnancy does constitute an exclusion factor in this influenza-related study. Positive test with one of the following methods for pregnancy excludes patient from participation:

• β-HCG blood test

• β-HCG urine test

• ultrasound examination confirming pregnancy.

4. Known or suspected immunosuppression (malignancy, transplant, immunosuppressive drugs)

5. Known allergy to oseltamivir.

6. Participation in any clinical trials with an investigational drug or vaccine within the previous 3 months.

7. A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant and adversely affecting compliance to study drug.