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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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).

Conditions

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Cystic Fibrosis

Keywords

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Cystic Fibrosis Continuous infusion Pharmacokinetics

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pharmacokinetics Piperacillin

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Kristina Öbrink-Hansen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eskild Petersen, Professor

Role: STUDY_DIRECTOR

Department of Infectious Diseases, Aarhus University Hospital, Denmark

Locations

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Department of Infectious Diseases, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CF-275-13

Identifier Type: -

Identifier Source: org_study_id