Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214331
First received: September 12, 2005
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Pregnancy
Drug: ciprofloxacin
Drug: azithromycin
Drug: gentamicin
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Enrollment: 150
Study Start Date: April 2003
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
ciprofloxacin
Drug: ciprofloxacin
ciprofloxacin 500 mg twice a day for five doses.
2
azithromycin
Drug: azithromycin
azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
3
gentamicin
Drug: gentamicin
a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who are prescribed antibiotics as part of their clinical care
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214331

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Food and Drug Administration (FDA)
Investigators
Study Chair: Gloria Sarto, MD, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214331     History of Changes
Other Study ID Numbers: 2002-524  FDA # 233-02-0114 
Study First Received: September 12, 2005
Last Updated: October 25, 2016

Additional relevant MeSH terms:
Anti-Bacterial Agents
Gentamicins
Ciprofloxacin
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on January 24, 2017