Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Goal of study:

To assess the tissular and plasma kinetics of ertapenem;

To determine the optimal dosages in the patients according to norepinephrine administration:

* to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status.
* to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine.

Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers

NCT03778320

Healthy Volunteers

COMPLETED PHASE1

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

NCT01148771

Healthy

COMPLETED PHASE4

Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients

NCT01414959

Pneumonia Abdominal Infection Urinary Tract Infection

COMPLETED

A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects

NCT04899219

Healthy

COMPLETED PHASE1

Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers

NCT00432068

Healthy Cholecystectomized

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

To Assess the Tissular and Plasma Kinetics of Ertapenem

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Noradrenalin infusion

Group Type EXPERIMENTAL

Ertapenem

Intervention Type DRUG

1g a day by drip of 30 min

2

No adrenalin infusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ertapenem

1g a day by drip of 30 min

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years and more
* negative pregnancy test
* HIV/HBV, HCV negative tests
* Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem

Exclusion Criteria

* refractory septic shock requiring use of additional catecholamines
* patients with positives tests for HIV, HBV, HCV
* pregnant females
* allergic insufficiency
* hemodiafiltration
* contraindication to microdialysis catheter set-up
* severe arteritis of lower extremities
* treatment with vasodilatators
* prior history of aorto-iliac shunt
* involvement in a clinical trial in the last three months
* exclusion from national records
* non affiliated to "securité sociale"

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No