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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01667094
Registration number
NCT01667094
Ethics application status
Date submitted
13/08/2012
Date registered
17/08/2012
Date last updated
20/04/2017
Titles & IDs
Public title
A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis
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Scientific title
Continuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis
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Secondary ID [1]
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U1111-1132-8291
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Secondary ID [2]
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249/12
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Universal Trial Number (UTN)
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Trial acronym
CISTIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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0
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Intermittent, short infusion Ceftazidime
Treatment: Drugs - Continuous infusion Ceftazidime
Treatment: Drugs - Intermittent, short infusion Meropenem
Treatment: Drugs - Continuous infusion Meropenem
Treatment: Drugs - Intermittent, short infusion Ticarcillin-clavulanate
Treatment: Drugs - Continuous infusion Ticarcillin-clavulanate
Treatment: Drugs - Intermittent, short infusion Cefepime
Treatment: Drugs - Continuous infusion Cefepime
Treatment: Drugs - Continuous infusion Piperacillin tazobactam
Treatment: Drugs - Intermittent, short infusion Piperacillin tazobactam
Active comparator: Intermittent, short infusion - Infusion over 30 minutes of either:
Cefepime 1g q8/24 OR Ceftazidime 2g q8/24 OR Meropenem 1g q8/24 OR Piperacillin-Tazobactam 4.5g q8/24 OR Ticarcillin-clavulanate 3.1g q6/24
Antibiotic chosen by treating physician
Experimental: Continuous infusion - Continuous infusion of either:
Cefepime 1.5g over 12h, q12/24 after initial loading dose of 500mg OR Ceftazidime 3g over 12h, q12/24 after initial loading dose 1g OR Meropenem 1.5g over 12h, q12/24 after initial loading dose 500mg OR Piperacillin-tazobactam 13.5g over 24h after initial loading dose 2.25g OR Ticarcillin-clavulanate 12.4g over 24h after initial loading dose 1.55g
Antibiotic chosen by treating physician
Treatment: Drugs: Intermittent, short infusion Ceftazidime
Ceftazidime 1g q8/24
Treatment: Drugs: Continuous infusion Ceftazidime
Ceftazidime loading dose 1g infused over 30mins then 3g infused over 12h q12/24
Treatment: Drugs: Intermittent, short infusion Meropenem
Meropenem 1g q8/24, infusion over 30 minutes
Treatment: Drugs: Continuous infusion Meropenem
Meropenem initial loading dose of 500mg infused over 30 minutes followed by 1.5g infused over 12/24, q12/24
Treatment: Drugs: Intermittent, short infusion Ticarcillin-clavulanate
Ticarcillin/clavulanate 3.1g q6/24
Treatment: Drugs: Continuous infusion Ticarcillin-clavulanate
Ticarcillin-clavulanate loading dose 1.55g followed by 12.4g infused over 24/24 q24/24
Treatment: Drugs: Intermittent, short infusion Cefepime
Cefepime 1g q8/24
Treatment: Drugs: Continuous infusion Cefepime
Cefepime loading dose 500mg followed by 1.5g infused over 12/24, q12/24
Treatment: Drugs: Continuous infusion Piperacillin tazobactam
Piperacillin tazobactam loading dose of 4.5g infused over 30 minutes followed by 18g infused over 24/24, q24/24
Treatment: Drugs: Intermittent, short infusion Piperacillin tazobactam
Piperacillin tazobactam 4.5g q6/24
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score
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Assessment method [1]
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Timepoint [1]
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Day 0 to Day 14
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Secondary outcome [1]
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Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory symptom score
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Assessment method [1]
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Timepoint [1]
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Day 0 to Day 7, Day 0 to Day 28
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Secondary outcome [2]
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Lung function testing; Forced volume expired in one second (FEV1)
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Assessment method [2]
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Timepoint [2]
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Day 0 to Day 7, Day 0 to Day 28
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Secondary outcome [3]
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C-reactive peptide (CRP)
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Assessment method [3]
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Timepoint [3]
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Day 0 to Day 3
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Secondary outcome [4]
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Quantitative bacterial load in sputum (total + Pseudomonas aeruginosa)
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Assessment method [4]
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Measured by PCR.
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Timepoint [4]
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Day 0 to Day 3, Day 0 to Day 7
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Secondary outcome [5]
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Time above minimum inhibitory concentration (MIC)
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Assessment method [5]
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Timepoint [5]
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Day 3
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Secondary outcome [6]
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Antibiotic stability
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Assessment method [6]
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For ceftazidime and meropenem, antibiotic levels will be measured from the infusion bag at the beginning and end of the infusion to determine the amount of degradation of these antibiotics.
The temperature of the infusion bags will be monitored continuously during this time.
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Timepoint [6]
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Day 3
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Secondary outcome [7]
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Pseudomonas aeruginosa virulence gene determinants
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Assessment method [7]
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A panel of different previously identified virulence gene determinants for Pseudomonas aeruginosa will be measured by RNA analysis.
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Timepoint [7]
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Day 0 to Day 3 and Day 0 to Day 7
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Eligibility
Key inclusion criteria
1. Patients >= 18 years of age,
2. Pseudomonas aeruginosa isolated in sputum within the last 12 months,
3. has an acute infective exacerbation, defined by international standards of 2 or more of the following in the last 2 weeks:
* change sputum volume or colour,
* increased cough,
* increased dyspnoea,
* increased malaise, fatigue or lethargy,
* anorexia or weight loss,
* decrease in pulmonary function by 10% or more, or
* new radiographic changes
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. patients < 18 yrs of age,
2. patients that do not meet the criteria for an acute infective exacerbation,
3. concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure,
4. impaired renal function with an estimated creatinine clearance < 60 mls/min,
5. patients allergic to ß-lactam antibiotics,
6. aminoglycoside contra-indicated,
7. intravenous antibiotics in the last 2 weeks, prior to this admission,
8. received more than 24 hours of intravenous antibiotics in this admission,
9. previous lung transplantation,
10. pregnancy or lactation, or
11. inability to consent.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2017
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Actual
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung infections. This usually results in worsening respiratory symptoms and often an acute deterioration in their lung function. They are usually treated with antibiotics that target the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous infusions several times a day. This study aims to compare the standard method of giving these antibiotics with a different strategy of giving these antibiotics to see if this can improve the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa in the lungs of these patients. This strategy consists of giving the same antibiotics continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to be able to kill the bacteria.
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Trial website
https://clinicaltrials.gov/study/NCT01667094
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anton Peleg, MBBS, FRACP.
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01667094
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