Pharmacokinetics and Pharmacodynamics and Selected Antibi... | NCT00214331

Studies
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

NCT00214331

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 27, 2016Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

ciprofloxacin
azithromycin
gentamicin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FDA # 233-02-0114

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Name	Class
Food and Drug Administration (FDA)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
1	ciprofloxacin	Drug: ciprofloxacin
2	azithromycin	Drug: azithromycin
3	gentamicin	Drug: gentamicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ciprofloxacin	Drug	ciprofloxacin 500 mg twice a day for five doses.	1

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gloria Sarto, MD, PhD	University of Wisconsin, Madison	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53715	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002939	Ciprofloxacin
D017963	Azithromycin
D005839	Gentamicins

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided