drugset / Trial / NCT01694069

Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis

NCT01694069

Phase 4 Terminated 6 enrolled West Virginia University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa. Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day.

Timeline

Start
2012-09
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Piperacillin Small molecule 400 mg/kg Intravenous
Subject Tazobactam Small molecule Intravenous

Indications