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

NCT01983787 | Completed Results

• 1 other identifier: CF-275-13
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Continuous infusion; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Blood-plasma Concentration of Piperacillin

  The free, non-protein bound fraction of plasma piperacillin for each patient was determined using Ultra High Performance Liquid Chromatography. The concentration was compared to the MIC-value (Minimal Inhibitory Concentration) of the pathogen isolated in a sputum sample collected prior to initiation of antibiotic treatment. Infusion pumps with 16 g of piperacillin per 24 hours were initially used and five patients had piperacillin plasma-concentrations monitored during this treatment regimen. However, in three of these patients, the piperacillin plasma concentrations were unexpectedly low and dropped to a level below the MIC. This was found to be due to antibiotic crystallization within the infusion pumps as a result of the antibiotic concentration being too high. Consequently, infusion pumps with 12 g of piperacillin per 24 hours were used in stead. The median piperaillin concentrations reported below are derived from all measurements within the two weeks of treatment.

  Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment

Secondary Outcomes (2)

• The Time Above the Minimum Inhibitory Concentration (T>MIC)

  Patients will be followed for the duration of treatment, which is approximately 2 weeks.

• MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.

  Sputum sample was collected 3 to 7 days before treatment initiation.

Study Arms (1)

Pharmacokinetics Piperacillin

Patients with cystic fibrosis , treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations.

You may qualify if:

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

You may not qualify if:

• Age under 18

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, Aarhus N, 8220, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Kristina Öbrink-Hansen
• Organization: Aarhus University Hospital, Department of infectious diseases

krisoebr@rm.dk

+4578452845

Study Officials

• Eskild Petersen, Professor

  Department of Infectious Diseases, Aarhus University Hospital, Denmark

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: November 14, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 11, 2015
• Results First Posted: October 1, 2015

Record last verified: 2015-11

Locations

DK (1)