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

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.

Conditions

• Cystic Fibrosis

Interventions

DRUG

Intermittent, short infusion Ceftazidime

Ceftazidime 1g q8/24

DRUG

Continuous infusion Ceftazidime

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

DRUG

Intermittent, short infusion Meropenem

Meropenem 1g q8/24, infusion over 30 minutes

DRUG

Continuous infusion Meropenem

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

DRUG

Intermittent, short infusion Ticarcillin-clavulanate

Ticarcillin/clavulanate 3.1g q6/24

DRUG

Continuous infusion Ticarcillin-clavulanate

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

DRUG

Intermittent, short infusion Cefepime

Cefepime 1g q8/24

DRUG

Continuous infusion Cefepime

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

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

DRUG

Intermittent, short infusion Piperacillin tazobactam

Piperacillin tazobactam 4.5g q6/24

Sponsors & Collaborators

• The Alfred

  lead OTHER

Principal Investigators

• Anton Peleg, MBBS, FRACP. · The Alfred

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2017-07-31

Completion

2017-07-31

Countries

• Australia

Study Locations