Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
Kristina Öbrink-Hansen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01983787
First received: July 11, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).

It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.


Condition Intervention Phase
Cystic Fibrosis
Procedure: Blood test
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Blood-plasma concentration of Piperacillin [ Time Frame: 4-5times during 2 weeks of treatment ] [ Designated as safety issue: No ]
    To describe the plasma concentration of Piperacillin, when this is given as continuous infusion, 16 grams daily, in a period of two weeks. The concentration is compared to the MIC-value (Minimal Inhibitory Concentration).


Secondary Outcome Measures:
  • The time above the minimum inhibitory concentration (T>MIC) [ Time Frame: Patients will be followed for the duration of treatment, which is approximately 2 weeks. ] [ Designated as safety issue: No ]
    The time, expressed in percentage, the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment.


Biospecimen Retention:   Samples Without DNA

Whole blood


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Continuous infusion
Cystic Fibrosis patients with acute pulmonary exacerbations, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
Procedure: Blood test

Detailed Description:

Patients with cystic fibrosis (CF) are often colonized with multidrug-resistant microorganisms, which increases the risk of suboptimal dosing of antibiotics as the time above the minimum inhibitory concentration (T>MIC) is suboptimal. Continuous infusion of beta-lactam antibiotics is more likely to optimize T>MIC than intermittent infusion. At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with CF, suffering from acute pulmonary exacerbations (APE). It is an outpatient treatment, and the patients are given 16 g of piperacillin per 24 hours. To assess the efficacy and quality of the treatment, a blood test every 3rd day will be required to monitor the blood-plasma concentration of piperacillin, as well as C-reactive protein (CRP) and white blood cell count (WBC).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations.

Criteria

Inclusion Criteria:

  • Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations, treated with continuous infusion of Piperacillin/Tazobactam for a period of two weeks.

Exclusion Criteria:

  • Age under 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983787

Locations
Denmark
Department of Infectious Diseases, Aarhus University Hospital Recruiting
Aarhus, Aarhus N, Denmark, 8220
Contact: Kristina Öbrink-Hansen, MD    26133705    krisoebr@rm.dk   
Contact: Eskild Petersen, MD, Assoc. Prof., D.Sc.    +45 7845 2817    joepeter@rm.dk   
Principal Investigator: Kristina Öbrink-Hansen, MD         
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

Responsible Party: Kristina Öbrink-Hansen, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01983787     History of Changes
Other Study ID Numbers: CF-275-13
Study First Received: July 11, 2013
Last Updated: November 20, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Cystic Fibrosis
Continuous infusion
Pharmacokinetics

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Piperacillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014