A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis
CISTIC
Continuous-infusion Anti-pseudomonal β-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2012
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 20, 2017
April 1, 2017
4.8 years
August 13, 2012
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score
Day 0 to Day 14
Secondary Outcomes (7)
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory symptom score
Day 0 to Day 7, Day 0 to Day 28
Lung function testing; Forced volume expired in one second (FEV1)
Day 0 to Day 7, Day 0 to Day 28
C-reactive peptide (CRP)
Day 0 to Day 3
Quantitative bacterial load in sputum (total + Pseudomonas aeruginosa)
Day 0 to Day 3, Day 0 to Day 7
Time above minimum inhibitory concentration (MIC)
Day 3
- +2 more secondary outcomes
Study Arms (2)
Intermittent, short infusion
ACTIVE COMPARATORInfusion 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
Continuous infusion
EXPERIMENTALContinuous 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
Interventions
Ceftazidime loading dose 1g infused over 30mins then 3g infused over 12h q12/24
Meropenem 1g q8/24, infusion over 30 minutes
Meropenem initial loading dose of 500mg infused over 30 minutes followed by 1.5g infused over 12/24, q12/24
Ticarcillin/clavulanate 3.1g q6/24
Ticarcillin-clavulanate loading dose 1.55g followed by 12.4g infused over 24/24 q24/24
Cefepime loading dose 500mg followed by 1.5g infused over 12/24, q12/24
Piperacillin tazobactam loading dose of 4.5g infused over 30 minutes followed by 18g infused over 24/24, q24/24
Piperacillin tazobactam 4.5g q6/24
Eligibility Criteria
You may qualify if:
- Patients \>= 18 years of age,
- Pseudomonas aeruginosa isolated in sputum within the last 12 months,
- 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
You may not qualify if:
- patients \< 18 yrs of age,
- patients that do not meet the criteria for an acute infective exacerbation,
- concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure,
- impaired renal function with an estimated creatinine clearance \< 60 mls/min,
- patients allergic to ß-lactam antibiotics,
- aminoglycoside contra-indicated,
- intravenous antibiotics in the last 2 weeks, prior to this admission,
- received more than 24 hours of intravenous antibiotics in this admission,
- previous lung transplantation,
- pregnancy or lactation, or
- inability to consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Alfredlead
Study Sites (1)
The Alfred Hospital
Melbourne, Victoria, 3181, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anton Peleg, MBBS, FRACP.
The Alfred
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 13, 2012
First Posted
August 17, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
April 20, 2017
Record last verified: 2017-04