Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 8 - Any |
| Updated: | 5/3/2014 |
| Start Date: | September 2012 |
| End Date: | December 2014 |
| Contact: | Lisa Biondo, PharmD |
| Email: | biondol@wvuhealthcare.com |
Continuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
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.
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.
All patients will receive combination therapy to include piperacillin-tazobactam 400
mg/kg/day (based on piperacillin component, actual body weight) not to exceed 16 grams and
tobramycin 12 mg/kg/day extended interval dosing (once daily). Patients randomized to the
continuous infusion group will receive a one-time loading dose of 100 mg/kg over 30 minutes
followed immediately by initiation of the continuous infusion.
Other antibiotics with activity against Pseudomonas aeruginosa are not allowed. Patients may
receive an antibiotic for treatment of Staphylococcus aureus if deemed appropriate.
Other treatments for pulmonary exacerbation of cystic fibrosis will be left up to the
control of the treating physician. Patients will receive a total of 14 days of therapy. If
deemed appropriate, patients may be discharged to home where they will continue to receive
blinded treatment via an infusion pump. Patients will be evaluated after completing their 14
day course of antibiotics (end of therapy).
mg/kg/day (based on piperacillin component, actual body weight) not to exceed 16 grams and
tobramycin 12 mg/kg/day extended interval dosing (once daily). Patients randomized to the
continuous infusion group will receive a one-time loading dose of 100 mg/kg over 30 minutes
followed immediately by initiation of the continuous infusion.
Other antibiotics with activity against Pseudomonas aeruginosa are not allowed. Patients may
receive an antibiotic for treatment of Staphylococcus aureus if deemed appropriate.
Other treatments for pulmonary exacerbation of cystic fibrosis will be left up to the
control of the treating physician. Patients will receive a total of 14 days of therapy. If
deemed appropriate, patients may be discharged to home where they will continue to receive
blinded treatment via an infusion pump. Patients will be evaluated after completing their 14
day course of antibiotics (end of therapy).
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
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