drugset / Trial / NCT01667094

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

NCT01667094

Phase 4 Unknown 50 enrolled The Alfred
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2012-09
Primary completion
2017-07
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 4.5 g Intravenous
Comparator Amoxicillin Other / unclassified 18 g Intravenous
Comparator Cefepime Small molecule 1 g Intravenous
Comparator Cefepime Small molecule 1.5 g Intravenous
Comparator Ceftazidime Small molecule 1 g Intravenous
Comparator Ceftazidime Small molecule 3 g Intravenous
Comparator Meropenem Small molecule 1 g Intravenous
Comparator Meropenem Small molecule 1.5 g Intravenous
Comparator ticarcillin-clavulanate Unknown 3.1 g Intravenous
Comparator ticarcillin-clavulanate Unknown 12.4 g Intravenous

Indications