NCT01667094

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

Continuous-infusion Anti-pseudomonal β-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The Alfred · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2012-08-17
• Last updated: 2017-04-20

Locations

1 site across 1 country: Australia