Patients With Urosepis and Received Ertapenem for TreatmentPhase 4NCT03859362
Ertapenem in Patients With Urosepsis
A Phase 4 study testing Ertapenem Injection in people with Patients With Urosepis and Received Ertapenem for Treatment, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Ertapenem, a broad-spectrum carbapenem antibiotic, has shown promising in vitro activity agenst ESBL-producing Enterobacteriacae. This agent was licensed in United State of America and Europe for several clinical use in complicated intraabdominal infections, complicated skin and skin-structure infections, acute pelvic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Urosepis and Received Ertapenem for Treatment
- What is being tested?
- Ertapenem Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2017to 31 Dec 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Diagnosis of urosepsis
Who cannot join
- They were pregnant
- Circulatory shock (defined as a systolic blood pressure of < 90 mmHg and pour tissue perfusion)
- Documented hypersensitivity to carbapenems
- Estimated creatinine clearance (CLcr) (determined by the Crockcroft-Goult method) of < 30 mL/min
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Pharmacodynamics of Ertapenem in Patients With Urosepsis
Ertapenem, a broad-spectrum carbapenem antibiotic, has shown promising in vitro activity agenst ESBL-producing Enterobacteriacae. This agent was licensed in United State of America and Europe for several clinical use in complicated intraabdominal infections, complicated skin and skin-structure infections, acute pelvic infections, complicated urinary tract infections and community-acquired pneumonia. In common with other beta-lactams, ertapenem exhibits primarily time-dependent activity, and the percentage of the exposure time during which the free drug concentration remain above the MIC (%T>MIC) is the pharmacokinetic/pharmacodynamics (PK/PD) index that best correlates with efficacy. Pathophysiological changes in critically ill patients with severe infections resulting in altered PK patterns that may affect therapeutic plasma concentrations and achievement of PD have been found with several antimicrobial agents. The aim of the study was to determine the PK of ertapenem in patients with urosepsis.
- Being tested
- Ertapenem Injection
- Keywords
- pharmacokinetic, pharmacodynamic, ertapenem, urosepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ertapenem InjectionDrug
1 g of ertapenem q24h, 30 min infusion
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem in urosepsis | Experimental | Ertapenem PK studies were carried out on the 3rd dose of ertapenem administration. Blood samples (3 mL) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h after the start of ertapenem administration. All blood samples were added to a heparinized tube and centrifuged at 1,000 g for 10 min at 4°C within 5 min. Receives: Drug: Ertapenem Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of ertapenem in plasma
Measured: 48 hours after the ertapenem dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study startJan 2017
- Primary completion30 Dec 2018
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Urosepis and Received Ertapenem for TreatmentStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sutep Jaruratanasirikul, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859362
- Sponsor's protocol ID
- ERTAESBL58372141
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics of Ertapenem in Patients With Urosepsis
- ClinicalTrials.gov ID
- NCT03859362
- Acronym / sponsor ID
- ERTAESBL58372141
- Keywords
- pharmacokinetic, pharmacodynamic, ertapenem, urosepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Mar 2019 (actual)
- 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.
Ertapenem, a broad-spectrum carbapenem antibiotic, has shown promising in vitro activity agenst ESBL-producing Enterobacteriacae. This agent was licensed in United State of America and Europe for several clinical use in complicated intraabdominal infections, complicated skin and skin-structure infections, acute pelvic infections, complicated urinary tract infections and community-acquired pneumonia. In common with other beta-lactams, ertapenem exhibits primarily time-dependent activity, and the percentage of the exposure time during which the free drug concentration remain above the MIC (%T>MIC) is the pharmacokinetic/pharmacodynamics (PK/PD) index that best correlates with efficacy. Pathophysiological changes in critically ill patients with severe infections resulting in altered PK patterns that may affect therapeutic plasma concentrations and achievement of PD have been found with several antimicrobial agents. The aim of the study was to determine the PK of ertapenem in patients with urosepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ertapenem in urosepsis | Experimental | Drug: Ertapenem InjectionErtapenem PK studies were carried out on the 3rd dose of ertapenem administration. Blood samples (3 mL) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h after the start of ertapenem administration. All blood samples were added to a heparinized tube and centrifuged at 1,000 g for 10 min at 4°C within 5 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Diagnosis of urosepsis
Key exclusion criteria (4 listed)
- They were pregnant
- Circulatory shock (defined as a systolic blood pressure of < 90 mmHg and pour tissue perfusion)
- Documented hypersensitivity to carbapenems
- Estimated creatinine clearance (CLcr) (determined by the Crockcroft-Goult method) of < 30 mL/min
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 |
|---|---|---|
| Ertapenem Injection1 g of ertapenem q24h, 30 min infusion | Drug | Ertapenem in urosepsis |
Primary outcome
Concentration of ertapenem in plasma
Time frame: 48 hours after the ertapenem dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injection in people with Patients With Urosepis and Received Ertapenem for Treatment, run by Prince of Songkla University at 1 site in Thailand.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Mar 2019. 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 Thailand. 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?
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?
Concentration of ertapenem in plasma (time frame: 48 hours after the ertapenem dose). 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 1 Mar 2019.