Ertapenem in Patients With Urosepsis | NCT03859362

Studies
Ertapenem in Patients With Urosepsis

NCT03859362

Sponsor

Prince of Songkla University

Status

Unknown status

Last Update Posted

Mar 1, 2019Actual

Enrollment

12Estimated

Phase

Phase 4

Conditions

Patients With Urosepis and Received Ertapenem for Treatment

Interventions

Ertapenem Injection

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Dec 30, 2018Actual

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Feb 25, 2019

First Submission Date that Met QC Criteria

Feb 28, 2019

First Posted Date

Mar 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2019

Last Update Posted Date

Mar 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sutep Jaruratanasirikul, Principle Investigator, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Ertapenem Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ertapenem Injection	Drug	1 g of ertapenem q24h, 30 min infusion	Ertapenem in urosepsis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of ertapenem in plasma		48 hours after the ertapenem dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years of age
Diagnosis of urosepsis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D000077727	Ertapenem

Ancestor Terms

ID	Term
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

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Browse Branches

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