Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
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ClinicalTrials.gov Identifier: NCT00214331 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : October 27, 2016
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Condition or disease | Intervention/treatment |
---|---|
Pregnancy | Drug: ciprofloxacin Drug: azithromycin Drug: gentamicin |
Study Type : | Observational |
Actual Enrollment : | 150 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy |
Study Start Date : | April 2003 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |
Group/Cohort | Intervention/treatment |
---|---|
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 |

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214331
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53715 |
Study Chair: | Gloria Sarto, MD, PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00214331 |
Other Study ID Numbers: |
2002-524 FDA # 233-02-0114 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | October 27, 2016 |
Last Verified: | October 2016 |
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