Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Virginia University
• Treatments: Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

1. Diagnosis of cystic fibrosis

2. 8 years of age or greater

3. Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria

4. Pulmonary exacerbation as defined by Fuchs et al.

Exclusion Criteria:

1. Admission for greater than 48 hours prior to enrollment

2. Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months

3. Current treatment for allergic bronchopulmonary aspergillosis

4. Pregnant or breast feeding

5. History of solid organ transplantation

6. Renal impairment at time of randomization (< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those < 18 years of age) or receipt of hemodialysis

7. Allergy to study medication