Clinical Trials Logo
  1. Home
  2. Pregnancy
  3. NCT00214331
  4. Details
NCT00214331 Clinical Trial

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Pregnancy Clinical Trial

Official title:
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00214331
Other study ID # 2002-524
Secondary ID FDA # 233-02-011
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated October 25, 2016
Start date April 2003
Est. completion date August 2010

Study information
Verified date October 2016
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• ciprofloxacin
ciprofloxacin 500 mg twice a day for five doses.
• azithromycin
azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
• gentamicin
a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes

Locations
Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
University of Wisconsin, Madison Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Completed NCT02523755 - Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia Phase 4