An exploratory pharmacokinetic and pharmacodynamic study of beta-lactam and fluoroquinolone in ICU patients

Recruiting

Conditions: Sepsis
bacterial infection
10004018

Registration Number: NL-OMON43959

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

All the patients admitted to the ICU or internal medicine ward 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:
* Written informed consent has been obtained from the patient or their legally authorized representative.
* Receiving intravenous antibiotic therapy of the target drugs.
* Suitable intravenous/intra-arterial access to facilitate sample collection.
* Treatment should be aimed for at least at 3 days.
* Bacterial isolates sample are obtainable before start of the target drugs.

Exclusion Criteria

* Consent not obtained.
* <18 years of age.
* Antibiotic cessation within 72h after start of the therapie.
* Medium care and burn wound patients admitted to the ICU.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Achievement of the PK/PD targets: time that free (unbound) fraction of<br /><br>beta-lactam concentration remains above the MIC during a dosing interval<br /><br>(100%T>MIC and 100%T>4xMIC) and for the fluoroquinolone the Area Under the<br /><br>concentration-time Curve for the free (unbound) fraction of above the MIC<br /><br>(fAUC/MIC) ratio, maximum serum concentration (fCmax) and the fCmax/MIC ratio.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comparison of observed PK/PD indices of the individual antibiotics with the<br /><br>length of ICU stay and sickness severity scores in ICU patients.</p><br>