A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Intermittent, short infusion Ceftazidime

Intervention Type DRUG

Ceftazidime 1g q8/24

Intermittent, short infusion Meropenem

Intervention Type DRUG

Meropenem 1g q8/24, infusion over 30 minutes

Intermittent, short infusion Ticarcillin-clavulanate

Intervention Type DRUG

Ticarcillin/clavulanate 3.1g q6/24

Intermittent, short infusion Cefepime

Intervention Type DRUG

Cefepime 1g q8/24

Intermittent, short infusion Piperacillin tazobactam

Intervention Type DRUG

Piperacillin tazobactam 4.5g q6/24

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

Group Type EXPERIMENTAL

Continuous infusion Ceftazidime

Intervention Type DRUG

Ceftazidime loading dose 1g infused over 30mins then 3g infused over 12h q12/24

Continuous infusion Meropenem

Intervention Type DRUG

Meropenem initial loading dose of 500mg infused over 30 minutes followed by 1.5g infused over 12/24, q12/24

Continuous infusion Ticarcillin-clavulanate

Intervention Type DRUG

Ticarcillin-clavulanate loading dose 1.55g followed by 12.4g infused over 24/24 q24/24

Continuous infusion Cefepime

Intervention Type DRUG

Cefepime loading dose 500mg followed by 1.5g infused over 12/24, q12/24

Continuous infusion Piperacillin tazobactam

Intervention Type DRUG

Piperacillin tazobactam loading dose of 4.5g infused over 30 minutes followed by 18g infused over 24/24, q24/24

Interventions

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Intermittent, short infusion Ceftazidime

Ceftazidime 1g q8/24

Intervention Type DRUG

Continuous infusion Ceftazidime

Ceftazidime loading dose 1g infused over 30mins then 3g infused over 12h q12/24

Intervention Type DRUG

Intermittent, short infusion Meropenem

Meropenem 1g q8/24, infusion over 30 minutes

Intervention Type DRUG

Continuous infusion Meropenem

Meropenem initial loading dose of 500mg infused over 30 minutes followed by 1.5g infused over 12/24, q12/24

Intervention Type DRUG

Intermittent, short infusion Ticarcillin-clavulanate

Ticarcillin/clavulanate 3.1g q6/24

Intervention Type DRUG

Continuous infusion Ticarcillin-clavulanate

Ticarcillin-clavulanate loading dose 1.55g followed by 12.4g infused over 24/24 q24/24

Intervention Type DRUG

Intermittent, short infusion Cefepime

Cefepime 1g q8/24

Intervention Type DRUG

Continuous infusion Cefepime

Cefepime loading dose 500mg followed by 1.5g infused over 12/24, q12/24

Intervention Type DRUG

Continuous infusion Piperacillin tazobactam

Piperacillin tazobactam loading dose of 4.5g infused over 30 minutes followed by 18g infused over 24/24, q24/24

Intervention Type DRUG

Intermittent, short infusion Piperacillin tazobactam

Piperacillin tazobactam 4.5g q6/24

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No