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Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

NCT ID: NCT00214331

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

ciprofloxacin

ciprofloxacin

Intervention Type DRUG

ciprofloxacin 500 mg twice a day for five doses.

2

azithromycin

azithromycin

Intervention Type DRUG

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

3

gentamicin

gentamicin

Intervention Type DRUG

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

Interventions

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ciprofloxacin

ciprofloxacin 500 mg twice a day for five doses.

Intervention Type DRUG

azithromycin

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

Intervention Type DRUG

gentamicin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gloria Sarto, MD, PhD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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FDA # 233-02-0114

Identifier Type: -

Identifier Source: secondary_id

2002-524

Identifier Type: -

Identifier Source: org_study_id