Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis

NCT01694069 | Terminated Phase 4 Results

• 1 other identifier: 24255
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

piperacillin; tazobactam; pseudomonas aeruginosa; cystic fibrosis; pulmonary exacerbation; continuous infusion; beta lactam

Outcome Measures

Primary Outcomes (1)

• Change in Forced Expiratory Volume at One Second (FEV1)

  FEV1 will be measured upon enrollment (day 0). FEV1 will also be measured at end of therapy (day 14). If FEV1 is available when patient was stable, prior to enrollment, this value will be treated as baseline FEV1. Change in FEV1 will be calculated from baseline (if available) to day 14 and also Day 0 to day 14

  Baseline, Day 0, and Day 14

Secondary Outcomes (8)

• Piperacillin Serum Concentrations

  Day 3

• Time to Next Pulmonary Exacerbation

  Patients will be followed up to 52 weeks from time of enrollment

• Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score

  Day 0 and day 14

• Change in Sputum Density of Pseudomonas Aeruginosa

  Day 0, day 3, and day 14

• Change in Weight

  Day 0 and day 14

Study Arms (2)

Intermittent Infusion piperacillin-tazobactam

ACTIVE COMPARATOR

Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day

Drug: Piperacillin-tazobactam combination product

Continuous infusion piperacillin-tazobactam

EXPERIMENTAL

Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily

Drug: Piperacillin-tazobactam combination product

Interventions

Piperacillin-tazobactam combination product DRUG

400 mg/kg/day as either intermittent or continuous infusion

Also known as: Zosyn

Continuous infusion piperacillin-tazobactam; Intermittent Infusion piperacillin-tazobactam

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cystic fibrosis
• years of age or greater
• Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria
• Pulmonary exacerbation as defined by Fuchs et al.

You may not qualify if:

• Admission for greater than 48 hours prior to enrollment
• Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months
• Current treatment for allergic bronchopulmonary aspergillosis
• Pregnant or breast feeding
• History of solid organ transplantation
• 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
• Allergy to study medication

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Healthcare

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Trials Compliance Coordinator
• Organization: West Virginia Universtiy, WVCTSI

ctgovadmin@hsc.wvu.edu

304-293-0216

Study Officials

• Lisa Biondo, PharmD

  West Virginia University Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 1, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-01

Locations

US (1)