Kinetic of Meropenem administration on 12 hours daily

Phase 1

• Conditions: infection with bacteria; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-003900-10-BE
• Lead Sponsor: Cliniques universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-15
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Adult > 18 years old (male or female)
- non-pregnant woman / breastfeeding
- Non-obese (BMI <30)
- Normal renal function (clearance >or = 60ml/min)
- Requiring meropenem treatment for a bacterial infection requiring a treatment duration of at least 10 days.
- The studied dosing regimen will be administered during the non-acute phase of the infection, i.e. 2 days before the planned discontinuation of treatment or discharge of the patient with HAD-OPA.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- pregnant woman
- creatinine clearance below 60ml/min

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the overall exposure to meropenene when administered at a dose of 2g 3x/d compared to the traditional regimen (2g 3x/d over 24h) in order to assess the feasibility of administering it at home.;Secondary Objective: Not applicable;Primary end point(s): Treatement ok;Timepoint(s) of evaluation of this end point: 09/2020

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable