An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT

NCT02962934 | Completed Results

• 1 other identifier: Royal_Brisbane
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to try to find out how critically ill patients receiving the antibiotic, ceftolozane-tazobactam, process it in their body. Investigators would like to study if the antibiotic concentrations during a dose of this antibiotic reaches the right concentrations necessary to kill the bacteria that is causing the infection. The process by which a drug travels through the body in blood, how it is broken down and removed by the body is called pharmacokinetics (PK). We can measure the PK by taking blood samples at specific times after the antibiotic is given. Investigators would like to do the study in patients receiving dialysis and patients who are not receiving dialysis. This information about how the antibiotic is processed in the critically ill patient is unknown and it is important to know whether the doses doctors give patients to fight infection are adequate. If antibiotic concentrations are low in the blood, it gives the bacteria an opportunity to become resistant to the antibiotic which can lead to the antibiotic being less effective against bacteria potentially exposing future patients with infections to a limited range of effective antibiotics. Patients will be consented, and given the antibiotic as prescribed. Blood samples will be taken from the drip that is already in the patients arm just as the antibiotic starts, at 15 and 45 minutes, at 1,2,3,4,5,6,7 and 8 hours. Patients who are on dialysis will have the blood samples taken from the dialysis machine before the blood reaches the dialysis filter (same blood samples as the non dialysis patients) and also bloods samples taken after the filter at 45 minutes, 2 and 6 hours. Dialysis patients will also have 5 separate samples of ultrafiltrate taken (approximately 10mls) - ultrafiltrate is the waste product of the dialysis process. The total amount of blood will be 40mls which is equal to about 2 tablespoons. The dialysis patient will have 50mls of blood taken.Information about the patients ICU stay will also be recorded.

Conditions

Gram-Negative Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Probability of Target Attainment for 40% fT>MIC

  The probability of attaining free concentrations above MIC for 40% of the time

  24 hour period

Study Arms (2)

Non CRRT group

Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy

Other: Non CRRT group

CRRT group

Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy

Other: CRRT group

Interventions

Non CRRT group OTHER

Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h.

Non CRRT group

CRRT group OTHER

CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h. Ultrafiltrate samples at 1 hr,2h 4h 6h 8h

CRRT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients receiving Ceftolozane-tazobactam for gram negative infection

You may qualify if:

• Group 1 Non CRRT
• Diagnosis of systemic infection known or suspected to be caused by an organism susceptible to ceftolozane-tazobactam
• Age more than 18 years
• The treating clinician considers Ceftolozane-tazobactam to be an appropriate agent to treat the infection Group 2 CRRT
• Diagnosis of systemic infection known or suspected to be caused by an organism susceptible to ceftolozane-tazobactam
• Age more than18 years
• Prescribed to receive CRRT
• The treating clinician considers Ceftolozane-tazobactam to be an appropriate agent to treat the infection

You may not qualify if:

• Group 1 Non CRRT
• Renal dysfunction that necessitates the use of renal replacement therapy
• Known or suspected allergy to cephalosporins
• Receipt of any Pipercillin-Tazobactam for the treatment of this current infection.
• Pregnancy Group 2 CRRT
• Known or suspected allergy to cephalosporins
• Pregnancy
• Receipt of any Pipercillin-Tazobactam for the treatment of this current infection

Sponsors & Collaborators

• Royal Brisbane and Women's Hospital: lead
• The University of Queensland: collaborator

Study Sites (1)

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, blood and ultrafiltrate

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Professor Jason Roberts
• Organization: University of Queensland Center for Clinical Research

j.roberts2@uq.edu.au

+61 7 334 65032

Study Officials

• Jason A Roberts, Professor

  Royal Brisbane and Womens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 15, 2016
• Study Start: November 30, 2016
• Primary Completion: June 30, 2019
• Study Completion: August 1, 2019
• Last Updated: October 2, 2019
• Results First Posted: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)