EndometritisPhase 1NCT01587495
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
A Phase 1 study testing Ertapenem in people with Endometritis, run by Daniel Benjamin at 1 site in United States.
Trial summary
The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Endometritis
- What is being tested?
- Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jan 2014
- Phase
- Phase 1
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older at the time of enrollment.
- Postpartum period < 42 days at the time of enrollment.
- Sufficient venous access to permit administration of study medication.
- 2 clinical signs of postpartum endometritis:
- Oral body temperature of > 101oF at any time, or a temperature of 100.4 on two occasions 6 hours apart.
- Maternal tachycardia that parallels the temperature.
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- Uterine tenderness
- Purulent vaginal discharge
- Findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment.
Who cannot join
- History of previous hypersensitivity reactions to beta lactams.
- Receiving valproic acid or divalproex sodium.
- Creatinine clearance < 30 mL/min as calculated by the Cockroft-Gault equation.
- Subject with a medical condition that, in the opinion of the investigator, would interfere with the pharmacokinetic evaluation of the medication, place the subject at an unacceptable risk of injury, or render the subject unable to meet the requirements of the protocol.
- Previous participation in the study.
- Exposure to ertapenem in the week prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.
Read the detailed description
Ertapenem has received FDA approval for the indication of acute pelvic infection, though there is no pharmacokinetic data to guide dosing of ertapenem in postpartum women. The physiologic changes of the postpartum period make it likely that this special population requires dosing modification to achieve desired therapeutic targets. The objective of this study is to obtain a detailed knowledge of the pharmacokinetics of ertapenem during the postpartum period that will result in improved guidelines on maternal dosing and neonatal exposure. This is a prospective, open-label, single center, pharmacokinetic study of ertapenem in women diagnosed with postpartum endometritis. Subjects will include up to 24 women receiving treatment for a diagnosis of postpartum endometritis with ertapenem in the Duke University Hospital Labor \& Delivery Unit. Each patient will participate in the study for approximately 7 days, though the total study duration is expected to be approximately 12 months. Descriptive statistics for the subjects will be calculated. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. All subjects who receive one dose of study drug will be followed for safety, with planned internal review of safety data following the completion of 12 patients. Nursing infants of study subjects will also be followed for safety due to the potential for exposure to study drug through breastmilk.
- Conditions
- Endometritis
- Being tested
- Ertapenem
- Medical subject headings
- Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
Also called Invanz
Ertapenem will be administered by intravenous infusion per the FDA approved standard of care (1 gram q24 hours). as follows:
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem | Experimental | Women diagnosed with postpartum endometritis Receives: Drug: Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure fraction of total and unbound Ertapenem.
The fraction of unbound drug will be calculated using total and unbound drug concentrations. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. PK parameters will be summarized by study cohort and compared using standard statistical methodology.
Measured: 2 years
Secondary outcomes (1)
Correlation between plasma drug concentrations and safety outcomes
Adverse events (AE) thought to be related (definitely and probably) to study drug and all serious adverse events (SAE) will be recorded. The investigator will provide date of onset and resolution, intensity, frequency, action(s) taken, changes in study drug dosing and outcome.The safety review will include all SAEs, all AEs thought to be possibly or probably related to the study drug, and all patients who discontinued participation in the study early.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: study terminated due to low subject accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Benjamin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Benjamin, Duke University
- Investigators
- Geeta Swamy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587495
- Sponsor's protocol ID
- Pro00030565
- Status last verified
- May 2015
- First submitted
- 5 Apr 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
- ClinicalTrials.gov ID
- NCT01587495
- Acronym / sponsor ID
- Pro00030565
- Conditions
- Endometritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to low subject accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Daniel BenjaminUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Apr 2012 (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.
The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.
Detailed description
Ertapenem has received FDA approval for the indication of acute pelvic infection, though there is no pharmacokinetic data to guide dosing of ertapenem in postpartum women. The physiologic changes of the postpartum period make it likely that this special population requires dosing modification to achieve desired therapeutic targets. The objective of this study is to obtain a detailed knowledge of the pharmacokinetics of ertapenem during the postpartum period that will result in improved guidelines on maternal dosing and neonatal exposure. This is a prospective, open-label, single center, pharmacokinetic study of ertapenem in women diagnosed with postpartum endometritis. Subjects will include up to 24 women receiving treatment for a diagnosis of postpartum endometritis with ertapenem in the Duke University Hospital Labor \& Delivery Unit. Each patient will participate in the study for approximately 7 days, though the total study duration is expected to be approximately 12 months. Descriptive statistics for the subjects will be calculated. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. All subjects who receive one dose of study drug will be followed for safety, with planned internal review of safety data following the completion of 12 patients. Nursing infants of study subjects will also be followed for safety due to the potential for exposure to study drug through breastmilk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ertapenem | Experimental | Drug: ErtapenemWomen diagnosed with postpartum endometritis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older at the time of enrollment.
- Postpartum period < 42 days at the time of enrollment.
- Sufficient venous access to permit administration of study medication.
- 2 clinical signs of postpartum endometritis:
- Findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment.
Key exclusion criteria (6 listed)
- History of previous hypersensitivity reactions to beta lactams.
- Receiving valproic acid or divalproex sodium.
- Creatinine clearance < 30 mL/min as calculated by the Cockroft-Gault equation.
- Subject with a medical condition that, in the opinion of the investigator, would interfere with the pharmacokinetic evaluation of the medication, place the subject at an unacceptable risk of injury, or render the subject unable to meet the requirements of the protocol.
- Previous participation in the study.
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 |
|---|---|---|
| ErtapenemAlso: InvanzErtapenem will be administered by intravenous infusion per the FDA approved standard of care (1 gram q24 hours). as follows: | Drug | Ertapenem |
Primary outcome
Measure fraction of total and unbound Ertapenem.
Time frame: 2 years
The fraction of unbound drug will be calculated using total and unbound drug concentrations. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. PK parameters will be summarized by study cohort and compared using standard statistical methodology.
1 secondary outcome
Correlation between plasma drug concentrations and safety outcomes
Time frame: 2 years
Results and safety
The study was stopped early (reason given: study terminated due to low subject accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
Geeta Swamy, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ertapenem in people with Endometritis, run by Daniel Benjamin 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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 May 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: study terminated due to low subject accrual). Results are not available in the source record.
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?
Measure fraction of total and unbound Ertapenem. (time frame: 2 years). 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 20 May 2015.