Clinical trial NCT01983787: Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
Official title: Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Continuous infusion
Pharmacokinetics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations.

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.

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 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

Primary outcomes:
measure: Blood-plasma Concentration of Piperacillin
timeFrame: Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment
Secondary outcomes:
measure: The Time Above the Minimum Inhibitory Concentration (T>MIC)
timeFrame: Patients will be followed for the duration of treatment, which is approximately 2 weeks.
measure: MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.
timeFrame: Sputum sample was collected 3 to 7 days before treatment initiation.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Infectious Diseases, Aarhus University Hospital
state: Aarhus N
Study officials:
affiliation: Department of Infectious Diseases, Aarhus University Hospital, Denmark
name: Eskild Petersen, Professor
role: STUDY_DIRECTOR
References: