An Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza during Lactation. - Observational PK study

• Conditions: actating women who present with clinical symptoms indicative of influenza will be recruited to receive immediate treatment with oseltamivir at a standard dose of 75 mg twice daily. These subjects will have a 12 hour pharmacokinetic plasma, urine and breast milk study undertaken after the steady state in oseltamivir concentrations (both active and inactive metabolites will be measured) is reached in blood, i.e. after three days after treatment.; MedDRA version: 12.1Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2010-019372-72-HU
• Lead Sponsor: Pharmahungary Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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: -ß-HCG blood test -ß-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: N/A;Primary end point(s): To study the relationship of the concentration of oseltamivir phosphate and its active metabolite oseltamivir carboxylate in the maternal blood and in breast milk/colostrum.;Main Objective: The main purpose of this study is to assess the potential neonatal exposure to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk/colostrum.