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Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214331
First received: September 12, 2005
Last updated: July 15, 2010
Last verified: July 2010
History of Changes

September 12, 2005
July 15, 2010
April 2003
April 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00214331 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

This protocol is a prospective, open-label, multicenter, population pharmacokinetic and pharmacodynamic study of selected anti-infective agents in pregnant women being treated for suspected or documented infections.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pregnant women who are prescribed antibiotics as part of their clinical care
Pregnancy
  • Drug: ciprofloxacin
    ciprofloxacin 500 mg twice a day for five doses.
  • Drug: azithromycin
    azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
  • Drug: gentamicin
    a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes
  • 1
    ciprofloxacin
    Intervention: Drug: ciprofloxacin
  • 2
    azithromycin
    Intervention: Drug: azithromycin
  • 3
    gentamicin
    Intervention: Drug: gentamicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women in their second or third trimester of pregnancy
  • Women currently receiving treatment or whose physician has made the decision to start treatment with ciprofloxacin, azithromycin or gentamicin for a suspected or documented infection
  • Of childbearing potential and who either have never been pregnant or whose most recent pregnancy ended 3 months previously (control group)
  • Women greater than 3 months postpartum and currently breast-feeding (substudy)

Exclusion Criteria:

  • Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents
Female
18 Years to 45 Years
Yes
Contact: Gloria Sarto, MD, PhD gsarto@wisc.edu
United States
 
NCT00214331
2002-524, FDA # 233-02-0114
Yes
Gloria Sarto, MD, PhD, University of Wisconsin
University of Wisconsin, Madison
Food and Drug Administration (FDA)
Study Chair: Gloria Sarto, MD, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP