what are the optimal doses of broad spectrum B-lactams to administer to obese patients if infected?

Phase 1

• Conditions: any patient with a BMI >= 30kg/m² and has a simple or severe infection.; MedDRA version: 14.0Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-004239-29-BE
• Lead Sponsor: Hopital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-19
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

-patient >= 18y
-any hospitalised obese patient (BMI >= 30kg/m²), receiving an intravenous broad spectrum B-lactam , for an infection (suspected or confirmed).
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-hemodialysis or renal replacement therapy
-pregnant woman

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine the pharmacocinetic parameters of broad spectrum B-lactams administred at usual doses in obese patients in order to propose dosing regimens of antibiotics based on patient weight. ;Secondary Objective: ;Primary end point(s):