HealthyPhase 4NCT01148771

Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

A Phase 4 study testing ertapenem in people with Healthy, run by Hartford Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
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: 12 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Oct 2010
Phase: Phase 4
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults (18 years of age or older)

Who cannot join

Ertapenem or other beta-lactam allergy
Pregnant or breast feeding females
Body Mass Index (BMI) greater than or equal to 30
Abnormal lab values at baseline
Hypertension
Significant medical abnormality
Regular alcohol consumption
Significant nicotine use

Trial locations and contacts

1 site in 1 country.

United States1 site

Hartford Hospital
Hartford, Connecticut, 06102

Other trials in United States

About this study

Official title: Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers

Conditions: Healthy
Being tested: ertapenem
Keywords: Pharmacokinetics, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ertapenemDrug
1 gram IV bolus every 24 hours (q24h) for 3 days
ertapenemDrug
1 gram 30 minute infusion q24h for 3 days

Study groups in NCT01148771
Study group	Role	What they receive
Ertapenem 1 gram intravenous (IV) 5 minute bolus	Experimental	Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus. Receives: Drug: ertapenem
Ertapenem 1 gram IV 30 minute infusion	Active comparator	Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose). Receives: Drug: ertapenem

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)
Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.
Measured: 5 or 30 minutes post start of infusion on Day 3
Area Under the Curve From 48 to 72 Hours [AUC(48-72)]
AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.
Measured: 0-24 hours after 3rd ertapenem dose

Secondary outcomes (2)

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The following laboratory assessments will be make before and after participation in the study to determine if objective changes occurred: blood pressure, pulse rate, temperature, complete blood count with differential, platelet count, blood urea nitrogen, serum creatinine, liver function panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase], total bilirubin, and urinalysis with microscopy. Monitoring of other pathologic or unintended changes in structure (signs),or function (symptoms) of the body associated with participation in the study will occur.
Measured: 3 days
Probability of Target Attainment (PTA)
After simulating 5000 patients receiving each dosing regimen, the probability of achieving free drug concentrations above an MIC of 0.25 mcg/mL and 0.5mcg/mL for at least 40% of the dosing interval (40% fT>MIC) is calculated at each MIC dilution.
Measured: Simulated Steady-State Exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Oct 2010

First posted22 Jun 2010 (estimated)
Study startAug 2010
Primary completionOct 2010
Study completionOct 2010

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 HealthyStudies 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 4
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01148771
Sponsor's protocol ID: KUTI003194HE
Other IDs: IISP ID#37935
Status last verified: Apr 2012
First submitted: 18 Jun 2010
Last updated: 11 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT01148771
Acronym / sponsor ID: KUTI003194HE
Conditions: Healthy
Keywords: Pharmacokinetics, Safety
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Hartford HospitalUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Aug 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 11 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ertapenem 1 gram intravenous (IV) 5 minute bolus	Experimental	Drug: ertapenemParticipants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus.
Ertapenem 1 gram IV 30 minute infusion	Active comparator	Drug: ertapenemParticipants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy adults (18 years of age or older)

Key exclusion criteria (8 listed)

Ertapenem or other beta-lactam allergy
Pregnant or breast feeding females
Body Mass Index (BMI) greater than or equal to 30
Abnormal lab values at baseline
Hypertension

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
ertapenem1 gram IV bolus every 24 hours (q24h) for 3 days	Drug	Ertapenem 1 gram intravenous (IV) 5 minute bolus
ertapenem1 gram 30 minute infusion q24h for 3 days	Drug	Ertapenem 1 gram IV 30 minute infusion

Primary outcome

Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)
Time frame: 5 or 30 minutes post start of infusion on Day 3
Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.
Area Under the Curve From 48 to 72 Hours [AUC(48-72)]
Time frame: 0-24 hours after 3rd ertapenem dose
AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.

2 secondary outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 days
Probability of Target Attainment (PTA)
Time frame: Simulated Steady-State Exposure

Results and safety

Results posted to the registry on 11 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion	6	6
Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus	6	6

Primary outcome: Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)

Time frame: 5 or 30 minutes post start of infusion on Day 3. Mean (Standard Deviation). Unit: mcg/mL

Measure	Ertapenem 1 Gram IV 5 Minute Bolus n = 11	Ertapenem 1 Gram IV 30 Minute Infusion n = 12
Value	193.33 (43.27)	165.70 (20.38)

Population analysed: Each participant received ertapenem as a 5 minute infusion and as a 30 minute infusion, only in different order due to cross-over design. Data for all participants receiving each dosage regimen are included in each arm for results.

Primary outcome: Area Under the Curve From 48 to 72 Hours [AUC(48-72)]

Time frame: 0-24 hours after 3rd ertapenem dose. Mean (Standard Deviation). Unit: mcg*hr/mL

Measure	Ertapenem 1 Gram IV 5 Minute Bolus n = 11	Ertapenem 1 Gram IV 30 Minute Infusion n = 12
Value	561.17 (77.01)	531.32 (56.86)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion	0 of 11 (0%)	10 of 11 (90.9%)	Not reported
Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus	0 of 12 (0%)	9 of 12 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
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.

Josepth L Kuti, PharmD principal investigator

Hartford Hospital

Dora E Wiskirchen, PharmD study director

Hartford Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ertapenem in people with Healthy, run by Hartford Hospital 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 1 inclusion and 8 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 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2012). 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?

Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose) (time frame: 5 or 30 minutes post start of infusion on Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01148771.

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 2012.