Status:
COMPLETED
A Study of the Pharmacology of Tamiflu in Pregnancy
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
H1N1 Influenza Treatment During Pregnancy
Eligibility:
FEMALE
14-45 years
Brief Summary
The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect the currently recommended ...
Detailed Description
The emergence of the novel H1N1 influenza virus has raised concern among public health officials and the public alike. Although initial reports suggested that the risk of serious disease or death was ...
Eligibility Criteria
Inclusion
- Taking or about to start oral oseltamivir for presumed influenza viral infection or for prophylaxis
- Able to give informed consent
- Pregnant female with singleton or multifetal gestation or healthy non-pregnant female (ancillary study)
Exclusion
- Unable to take medication orally
- Renal failure - creatinine \> 1.5
- Hct \<28
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01203527
Start Date
March 1 2007
End Date
October 1 2012
Last Update
October 9 2013
Active Locations (4)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
3
University of Texas Medical Branch
Galveston, Texas, United States, 77555
4
University of Washington
Seattle, Washington, United States, 98195