EndometritisPKAZNCT01464840
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
An observational study of Endometritis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis. Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometritis
- What is being tested?
- Azithromycin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women 19 years and older undergoing scheduled cesearean sections
Who may be able to join
- Women 19 years and older
- Term (37 weeks and greater)
- Singleton gestation
- Scheduled cesarean section
- Non-laboring
- Intact membranes
Who cannot join
- < 19 years of age
- Preterm (< 37 weeks)
- Multifetal gestation
- Laboring or ruptured membranes
- Known fetal anomaly
- Oligo- or polyhydramnios
Show all 13Show fewer
- Macrolide allergy
- Macrolide exposure within 2 weeks
- Medical co-morbidities
- Hepatic or renal impairment
- Taking medications that prolong the QT interval
- Currently taking nelfinavir, efavirenz, or flucanozole
- Structural heart defects or arrythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.
Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.
- Conditions
- Endometritis
- Being tested
- Azithromycin
- Keywords
- Pregnancy, Cesarean section, Antibiotic
- Medical subject headings
- Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zmax
500 mg intravenous infused over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| 15 minutes | 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. Receives: Drug: Azithromycin | |
| 30 minutes | 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. Receives: Drug: Azithromycin | |
| 60 minutes | 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.
Measured: 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndometritisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amelia Sutton, MD, PhD, University of Alabama at Birmingham
- Investigators
- Amelia L Sutton, M.D., Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464840
- Sponsor's protocol ID
- F101111007
- Acronym
- PKAZ
- Status last verified
- Apr 2017
- First submitted
- 26 Oct 2011
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01464840
- Acronym / sponsor ID
- PKAZ / F101111007
- Conditions
- Endometritis
- Keywords
- Pregnancy, Cesarean section, Antibiotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Posted 9 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.
Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 minutes | – | Drug: Azithromycin500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. |
| 30 minutes | – | Drug: Azithromycin500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. |
| 60 minutes | – | Drug: Azithromycin500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women 19 years and older undergoing scheduled cesearean sections
Key inclusion criteria (6 listed)
- Women 19 years and older
- Term (37 weeks and greater)
- Singleton gestation
- Scheduled cesarean section
- Non-laboring
Key exclusion criteria (13 listed)
- < 19 years of age
- Preterm (< 37 weeks)
- Multifetal gestation
- Laboring or ruptured membranes
- Known fetal anomaly
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 |
|---|---|---|
| AzithromycinAlso: Zmax500 mg intravenous infused over 1 hour | Drug | 15 minutes, 30 minutes, 60 minutes |
Primary outcome
Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
Time frame: 48 hours after delivery
The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Amelia L Sutton, M.D., Ph.D. principal investigator
University of Alabama at Birmingham
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 Endometritis, run by University of Alabama at Birmingham 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 6 inclusion and 13 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 11 May 2017. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration (time frame: 48 hours after delivery). It is what the study was designed to measure, not a finding.
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 11 May 2017.