Optimizing Dosing of Colistin for Infections Resistant to all Other Antibiotics

• Conditions: Bloodstream infection (bacteremia) or hospital-acquired pneumonia by Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacin; MedDRA version: 12.1Level: LLTClassification code 10060562Term: Bacteremia, unspecified; MedDRA version: 12.1Level: LLTClassification code 10064977Term: Acinetobacter bacteremia; MedDRA version: 12.1Level: LLTClassification code 10054228Term: Gram-negative bacteremia; MedDRA version: 12.1Level: LLTClassification code 10054279Term: Escherichia coli bacteremia; MedDRA version: 12.1Level: LLTClassification code 10054281Term: Escherichia bacteremia; MedDRA version: 12.1Level: LLTClassification code 10058883Term: Klebsiella bacteremia; MedDRA version: 12.1Level: LLTClassification code 10058884Term: Enterobacter bacteremia; MedDRA version: 12.1Level: LLTClassification code 10058925Term: Serratia bacteremia; MedDRA version: 12.1Level: LLTClassification code 10058926Term: Hemophilus bacteremia

• Registration Number: EUCTR2010-021413-23-GR
• Lead Sponsor: niversity of Athens, Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-17
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

1.Patient of 18 years of age or older
2.Expectation of hospitalization of = 48 hours
3.Receipt of intravenous colistin for clinical care
4.Provision of written informed consent by the patient or by a relative legally able to give proxy consent if the patient cannot give consent
5.Infection is defined by Center for Disease Control and Prevention (CDC) definitions of bloodstream infection (bacteremia) or hospital-acquired pneumonia:85
6.Patient must have growth from blood culture or a respiratory specimen culture of a Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacin
7.Adequate venous access to enable collection of blood for determination of CMS and generated colistin in plasma

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

Exclusion Criteria

1.Currently pregnant or breastfeeding
2.Currently incarcerated
3.Concomitant use of colistin or polymyxin B delivered directly into the respiratory tract
4.Known allergy to colistin or polymyxin B
5.Cystic fibrosis
6.Estimated life expectancy of less than one week

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the disposition of colistin in plasma in critically-ill patients;Secondary Objective: 1.To determine the clearance of colistin via renal replacement therapy<br>2. Toestablish the co-variates influencing the pharmacokinetics of colistin.<br>3. To establish the inter-relationships of the pharmacokinetics and pharmacodynamics of colistin with bacteriological and clinical outcomes<br>4. To investigate inter-relationships between the pharmacokinetics of colistin, duration of therapy and patient characteristics with development of bacterial resistance to colistin.;Primary end point(s): To characterize the disposition of colistin in plasma in critically-ill patients