Track topics on Twitter Track topics that are important to you
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.
Investigational Medical Product: Tamiflu® 75 mg hard capsules
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.
Study design: Single-country, multicenter, observational pharmacokinetic study
Enrolment and follow-up: Lactating women (up to 20 subjects) who present with clinical symptoms indicative of influenza will be recruited (a maximum of 6 months period of recruitment) to receive immediate treatment with oseltamivir (Tamiflu® 75 mg hard capsules, provided free of charges for the study) 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. Subjects do not need laboratory confirmation of influenza infection for inclusion in this study, although the results of any virological tests that seek to confirm influenza infection will be recorded. Maternal venous blood (2 samples, one pre-dose sample and one 2.5-hours-after-dose sample), urine samples (obtained from total urine output within 12 h), and breast milk/colostrum samples (8 samples within 12 h) are taken to determine oseltamivir phosphate (inactive metabolite) and oseltamivir carboxylate (active metabolite) levels.
Safety: Adverse events (AEs) and serious adverse events (SAEs) will be recorded. SAEs will be reported to the Ethics Committee and Regulatory authorities according to the reporting requirements in Hungary.
Number of patients: A total of 20 lactating patients will be enrolled.
Number of centres: Up to 3 investigational sites in Hungary will participate in the study. All sites will belong to an academic institution.
Time schedule: The patient visits are planned as soon as possible during the pandemic season in 2010. Last patient visit will be 6 months after the first patient visit, in Q2-Q4 2010. The study will run until enrolment is completed and all study procedures have been completed for the last subject.
Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Semmelweis University II. Clinic of Obstetrics and Gynecology
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:13:26-0400
This study is planned to characterize the pharmacokinetic properties of oseltamivir and the active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for th...
Seasonal influenza is responsible for many hospitalizations and deaths each year, despite effective antiviral treatments. Some individuals have medical conditions such as heart or lung dis...
Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to...
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the s...
The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Heal...
Benefits of breastfeeding are well established. What is more, breastfeeding is associated with lower healthcare costs. More U.S. hospitals are adopting the World Health Organization's Ten Steps to Suc...
Suboptimal breastfeeding contributes to morbidity and mortality in children. Studies in high-income countries (HICs) show that exclusive-breastfeeding (EBF) is associated with longer breastfeeding dur...
The United States has seen an increasing number of child-bearing women in medical training. We aimed to compare the prevalence of exclusive breastfeeding across varied specialties, whose trainees may ...
Of the various barriers to breastfeeding, limited information is available on the relationship between prenatal stress and breastfeeding. This study investigates the association between prenatal stres...
The benefits of breastfeeding are well known for mother and child. Research about the predictive factors related to the initiation and maintenance of breastfeeding is of great interest to public healt...
An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.
The transmission of infectious disease or pathogens from one generation to another. It includes transmission in utero or intrapartum by exposure to blood and secretions, and postpartum exposure via breastfeeding.
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...
Track and monitor developments in breast cancer research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...