Clinical Trial Results:
Plasma and intrapulmonary population pharmacokinetics of piperacillin/tazobactam in critically ill patients
Summary
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EudraCT number |
2011-004470-28 |
Trial protocol |
GB |
Global end of trial date |
31 Jul 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Apr 2020
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First version publication date |
11 Apr 2020
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Other versions |
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Summary report(s) |
Trial publication |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2011RM010
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Manchester University NHS Foundation Trust
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Sponsor organisation address |
Oxford Road, Manchester, United Kingdom,
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Public contact |
Lynne Webster, Manchester University NHS Foundation Trust, 0161 2764125, lynne.webster@mft.nhs.uk
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Scientific contact |
Lynne Webster, Manchester University NHS Foundation Trust, 0161 2764125, lynne.webster@mft.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jul 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jul 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary object of this study is to investigate changes over time in blood and lung concentrations of piperacillin and tazobactam in critically ill patients.
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Protection of trial subjects |
The initial approach will always be made by a member of the clinical team who will ask permission for the researcher to visit the patient. If permission is not granted anonymous details of the patients will be entered into the screening log. Any patient presenting with significant side effects from piperacillin/tazobactam will not have any further piperacillin/tazobactam administered. Patients may withdraw or be withdrawn by PerLR or ProfLR from the trial at any time.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 17
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Worldwide total number of subjects |
17
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EEA total number of subjects |
17
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
June 2012 to July 2013 Single UK centre | ||||||
Pre-assignment
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Screening details |
Intubated and mechanically ventilated patients who received piperacillin–tazobactam for suspected or documented pulmonary infection | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
No blinding
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Arms
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Arm title
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Pharmacokinetic | ||||||
Arm description |
Plasma and intra-pulmonary PK | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
piperacillin-tazobactam
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
piperacillin 4 grams
tazobactam 0.5 grams
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
PK analysis
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
PK analysis conducted for all trial participants
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End points reporting groups
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Reporting group title |
Pharmacokinetic
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Reporting group description |
Plasma and intra-pulmonary PK | ||
Subject analysis set title |
PK analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
PK analysis conducted for all trial participants
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End point title |
Lung penetration [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 5
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a pharmacokinetic study to investigate the plasma and lung concentration of piperacillin and tazobactam in critically ill patients. The outcome involves the development of a pharmacokinetic model. There is a single arm and no statistical comparisons are made. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
28 days
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Assessment type |
Non-systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
Pharmacokinetic
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Reporting group description |
Plasma and intra-pulmonary PK | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Jul 2012 |
1. Study of first dose and/or steady-state pharmacokinetics
2. Addition of Cardiothoracic Intensive Care Unit (CICU)
3. Adverse event reporting and exempt events
4. CRF as source data
5. Changes to consent at end of study
6. Removal of three medical qualified individual who are not longer involved in the study
7. Additions of comment regarding timing of steady-state
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05 Dec 2012 |
1. Patient numbers changed to a range of 25 to 40.
2. Raising of the upper age limit from 75 to 85
3. Removal of “suspected pulmonary infection” from enrolment criteria
4. Removal of requirement for 48 hours intubation and mechanical ventilation prior to commencing IMP
5. Translation research facility now Clinical Research Facility
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22 Jul 2013 |
1. Patient numbers changed to a range of 20 to 40. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/24926779 |