Dose individualization of beta-lactam and fluoroquinolone antibiotics in intensive care unit patients

Phase 1

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

• Registration Number: EUCTR2017-004677-14-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

All patients admitted to the ICU and given standard of care intravenous therapy of either one or both of the target antibiotic classes are included. Antibiotic initiation based on clinical suspicion of infection and/or cultured pathogens susceptible to the target drugs, initial dosage prescription, and duration of therapy are at the discretion of the attending physician.

In order to be eligible to participate in this study, a subject must also meet all of the following criteria:
•=18 years of age
•Receiving intravenous antibiotic therapy of the target drugs
•Treatment should be aimed for at least 2 days.

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Pregnancy
•Patient already enrolled in this trial
•Antibiotic cessation before sampling
•Medium care and burn wound patients admitted to the ICU
•Patients receiving cefotaxime as prophylaxis only within the context of Selective Digestive tract Decontamination (SDD)

Study & Design

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