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CompletedNCT00214331Updated Oct 27, 2016

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

An observational study in Pregnancy, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by University of Wisconsin, Madison · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pregnancy
03

In context

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women who are prescribed antibiotics as part of their clinical care

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

Exclusion Criteria:

  • Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)

Groups and cohorts

  • 1

    ciprofloxacin

    Drug: ciprofloxacin

  • 2

    azithromycin

    Drug: azithromycin

  • 3

    gentamicin

    Drug: gentamicin

Interventions

  • Drugciprofloxacin

    ciprofloxacin 500 mg twice a day for five doses.

  • Drugazithromycin

    azithromycin 500 mg on day 1 followed by 250 mg on days 2-5

  • Druggentamicin

    a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes

06

Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53715, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00214331
Lead sponsor
University of Wisconsin, Madison
Collaborators
Food and Drug Administration (FDA)
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Apr 2003
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Oct 27, 2016

Study contacts

Gloria Sarto, MD, PhD
study chair · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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