Clinical trial NCT01667094: A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis
Official title: Continuous-infusion Anti-pseudomonal β-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Pulmonary exacerbation
Continuous infusion
Antipseudomonal beta-lactams
Lead sponsor: The Alfred
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score
timeFrame: Day 0 to Day 14
Secondary outcomes:
measure: Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory symptom score
timeFrame: Day 0 to Day 7, Day 0 to Day 28
measure: Lung function testing; Forced volume expired in one second (FEV1)
timeFrame: Day 0 to Day 7, Day 0 to Day 28
measure: C-reactive peptide (CRP)
timeFrame: Day 0 to Day 3
measure: Quantitative bacterial load in sputum (total + Pseudomonas aeruginosa)
timeFrame: Day 0 to Day 3, Day 0 to Day 7
measure: Time above minimum inhibitory concentration (MIC)
timeFrame: Day 3
measure: Antibiotic stability
timeFrame: Day 3
measure: Pseudomonas aeruginosa virulence gene determinants
timeFrame: Day 0 to Day 3 and Day 0 to Day 7
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Anton Peleg, MBBS, FRACP.
role: PRINCIPAL_INVESTIGATOR
References: