PregnancyNCT00214331
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
An observational study of Pregnancy, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- ciprofloxacin, azithromycin and gentamicin
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who are prescribed antibiotics as part of their clinical care
Who may be able to join
- 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)
Who cannot join
- Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pregnancy
- Being tested
- ciprofloxacin, azithromycin, gentamicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacinDrug
ciprofloxacin 500 mg twice a day for five doses.
azithromycinDrug
azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
gentamicinDrug
a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | ciprofloxacin Receives: Drug: ciprofloxacin | |
| 2 | azithromycin Receives: Drug: azithromycin | |
| 3 | gentamicin Receives: Drug: gentamicin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Gloria Sarto, MD, PhD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214331
- Sponsor's protocol ID
- 2002-524
- Other IDs
- FDA # 233-02-0114
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2005
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
- ClinicalTrials.gov ID
- NCT00214331
- Acronym / sponsor ID
- 2002-524
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Apr 2003
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: ciprofloxacinciprofloxacin |
| 2 | – | Drug: azithromycinazithromycin |
| 3 | – | Drug: gentamicingentamicin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who are prescribed antibiotics as part of their clinical care
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciprofloxacinciprofloxacin 500 mg twice a day for five doses. | Drug | 1 |
| azithromycinazithromycin 500 mg on day 1 followed by 250 mg on days 2-5 | Drug | 2 |
| gentamicina single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes | Drug | 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Sarto, MD, PhD study chair
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.