Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 7 February 2022
• Main ID: NCT01694069
• Date of registration: 19/09/2012
• Prospective Registration: No
• Primary sponsor: West Virginia University
• Public title: Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis PIPE-CF
• Scientific title: Continuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
• Date of first enrolment: September 2012
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01694069
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Lisa Biondo, PharmD
• Affiliation: West Virginia University Healthcare

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Piperacillin-tazobactam combination product

Primary Outcome(s)

Change in Forced Expiratory Volume at One Second (FEV1) [Time Frame: Baseline, Day 0, and Day 14]

Secondary Outcome(s)

Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score [Time Frame: Day 0 and day 14]

Clinical Failure of Treatment [Time Frame: Day 14]

Piperacillin Serum Concentrations [Time Frame: Day 3]

Change in Weight [Time Frame: Day 0 and day 14]

Change in Sputum Density of Pseudomonas Aeruginosa [Time Frame: Day 0, day 3, and day 14]

Time to Defervescence [Time Frame: Day 0 to day 14]

Time to Next Pulmonary Exacerbation [Time Frame: Patients will be followed up to 52 weeks from time of enrollment]

Time to Normalization of White Blood Cell Count [Time Frame: Day to day 14]

Secondary ID(s)

24255

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/02/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01694069