NCT00214331

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

7.3 years

First QC Date

September 12, 2005

Last Update Submit

October 25, 2016

Conditions

Pregnancy

Study Arms (3)

1

ciprofloxacin

Drug: ciprofloxacin

2

azithromycin

Drug: azithromycin

3

gentamicin

Drug: gentamicin

Interventions

ciprofloxacinDRUG

ciprofloxacin 500 mg twice a day for five doses.

1
azithromycinDRUG

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

2
gentamicinDRUG

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

3

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Interventions

CiprofloxacinAzithromycinGentamicins

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Gloria Sarto, MD, PhD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

April 1, 2003

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(1)