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

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ClinicalTrials.gov Identifier: NCT01983787
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : October 1, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Kristina Öbrink-Hansen, University of Aarhus

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Cystic Fibrosis
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pharmacokinetics Piperacillin
Hide Arm/Group Description Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Pharmacokinetics Piperacillin
Hide Arm/Group Description Patients with cystic fibrosis and pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
1.Primary Outcome
Title Blood-plasma Concentration of Piperacillin
Hide Description

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.

Time Frame Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pharmacokinetics Piperacillin 16g/Day Pharmacokinetics Piperacillin 12g/Day
Hide Arm/Group Description:
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: mg/L
21
(5 to 33.5)
21
(15 to 42)
2.Secondary Outcome
Title The Time Above the Minimum Inhibitory Concentration (T>MIC)
Hide Description

The time, expressed in percentage, for which the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%. MIC for the pathogen in sputum was not reported in patient 5. Therefore,T>MIC for this patient could not be estimated.

Patient 1-5 were treated with piperacillin 16g/day. Patient 6-10 were treated with piperacillin 12g/day.

Time Frame Patients will be followed for the duration of treatment, which is approximately 2 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T>MIC 16g/Day, Patient 1 T>MIC 16g/Day, Patient 2 T>MIC 16g/Day, Patient 3 T>MIC 16g/Day, Patient 4 T>MIC12g/Day, Patient 6 T>MIC 12g/Day, Patient 7 T>MIC 12g/Day, Patient 8 T>MIC 12g/Day, Patient 9 T>MIC 12g/Day, Patient 10
Hide Arm/Group Description:
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Acromobacter. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
Overall Number of Participants Analyzed 1 1 1 1 1 1 1 1 1
Measure Type: Number
Unit of Measure: % of time above the MIC
100 100 75 75 100 100 100 100 100
3.Secondary Outcome
Title MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.
Hide Description MIC to piperacillin/tazobactam was obtained by using E-tests (AB Biodisk, Solna, Sweden) on Mueller-Hinton agar plates incubated at 35 ± 2 degrees Celcius with inoculum, incubation time and atmosphere in accordance to the E-test application guide.
Time Frame Sputum sample was collected 3 to 7 days before treatment initiation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patient 1 Patient 2 Patient 3 Patient 4 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10
Hide Arm/Group Description:
MIC (mg/L) of pathogen detected in sputum: 3 mg/L
MIC (mg/L) of pathogen detected in sputum: 8 mg/L
MIC (mg/L) of pathogen detected in sputum: 16 mg/L
MIC (mg/L) of pathogen detected in sputum: 3 mg/L
MIC (mg/L) of pathogen detected in sputum: 0.5 mg/L
MIC (mg/L) of pathogen detected in sputum: 3 mg/L
MIC (mg/L) of pathogen detected in sputum: 3 mg/L
MIC (mg/L) of pathogen detected in sputum: 0.75 mg/L
MIC (mg/L) of pathogen detected in sputum: 2 mg/L
Overall Number of Participants Analyzed 1 1 1 1 1 1 1 1 1
Measure Type: Number
Unit of Measure: mg/L
3 8 16 3 0.5 3 3 0.75 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pharmacokinetics Piperacillin
Hide Arm/Group Description Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
All-Cause Mortality
Pharmacokinetics Piperacillin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pharmacokinetics Piperacillin
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pharmacokinetics Piperacillin
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristina Öbrink-Hansen
Organization: Aarhus University Hospital, Department of infectious diseases
Phone: +4578452845
EMail: krisoebr@rm.dk
Layout table for additonal information
Responsible Party: Kristina Öbrink-Hansen, University of Aarhus
ClinicalTrials.gov Identifier: NCT01983787     History of Changes
Other Study ID Numbers: CF-275-13
First Submitted: July 11, 2013
First Posted: November 14, 2013
Results First Submitted: June 29, 2015
Results First Posted: October 1, 2015
Last Update Posted: December 11, 2015