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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01667094
• Date of registration: 13/08/2012
• Prospective Registration: Yes
• Primary sponsor: The Alfred
• Public title: A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis CISTIC
• Scientific title: Continuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis
• Date of first enrolment: September 2012
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01667094
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Anton Peleg, MBBS, FRACP.
• Affiliation: The Alfred

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Intermittent, short infusion Cefepime

Drug: Intermittent, short infusion Ticarcillin-clavulanate

Drug: Continuous infusion Ticarcillin-clavulanate

Drug: Intermittent, short infusion Meropenem

Drug: Intermittent, short infusion Piperacillin tazobactam

Drug: Intermittent, short infusion Ceftazidime

Drug: Continuous infusion Cefepime

Drug: Continuous infusion Ceftazidime

Drug: Continuous infusion Meropenem

Drug: Continuous infusion Piperacillin tazobactam

Primary Outcome(s)

Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score [Time Frame: Day 0 to Day 14]

Secondary Outcome(s)

Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory symptom score [Time Frame: Day 0 to Day 7, Day 0 to Day 28]

C-reactive peptide (CRP) [Time Frame: Day 0 to Day 3]

Lung function testing; Forced volume expired in one second (FEV1) [Time Frame: Day 0 to Day 7, Day 0 to Day 28]

Antibiotic stability [Time Frame: Day 3]

Pseudomonas aeruginosa virulence gene determinants [Time Frame: Day 0 to Day 3 and Day 0 to Day 7]

Quantitative bacterial load in sputum (total + Pseudomonas aeruginosa) [Time Frame: Day 0 to Day 3, Day 0 to Day 7]

Time above minimum inhibitory concentration (MIC) [Time Frame: Day 3]

Secondary ID(s)

249/12

U1111-1132-8291

Source(s) of Monetary Support

Please refer to primary and secondary sponsors