Cystic FibrosisPhase 4PIPE-CFNCT01694069
Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis
A Phase 4 study testing Piperacillin-tazobactam combination product in people with Cystic Fibrosis, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Piperacillin-tazobactam combination product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of cystic fibrosis
- 8 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Healthcare
Morgantown, West Virginia, 26505
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Cystic Fibrosis
- Being tested
- Piperacillin-tazobactam combination product
- Keywords
- piperacillin, tazobactam, pseudomonas aeruginosa, cystic fibrosis, pulmonary exacerbation, continuous infusion, beta lactam
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin-tazobactam combination productDrug
Also called Zosyn
400 mg/kg/day as either intermittent or continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Piperacillin-tazobactam combination product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Day 0, and Day 14
Secondary outcomes (8)
Piperacillin Serum Concentrations
Serum piperacillin concentration will be measured as follows:
- Intermittent infusion arm: prior to dose (trough), 30 minutes (after completion of infusion), and at 4 hours
- Continuous infusion arm: collected at the same time as in the intermittent infusion arm
Measured: Day 3
Time to Next Pulmonary Exacerbation
Patients will be followed for time of next subsequent pulmonary exacerbation for up to 52 weeks after completion of receiving study drug. Next pulmonary exacerbation is defined as requiring admission to a hospital for receipt of I.V. antibiotics because of a diagnosis of pulmonary exacerbation.
Measured: Patients will be followed up to 52 weeks from time of enrollment
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
The validated CFQ-R will be administered to patients at time of enrollment at end of therapy
Measured: Day 0 and day 14
Change in Sputum Density of Pseudomonas Aeruginosa
Sputum density of Pseudomonas aeruginosa will be determined at enrollment, day 3, and at end of therapy
Measured: Day 0, day 3, and day 14
Change in Weight
The change in weight will be documented from enrollment to end of therapy
Measured: Day 0 and day 14
Time to Defervescence
Temperature will be taken multiple times daily according to standard of care. If patients present febrile, time until patient is afebrile and remains afebrile for 24 hours will be recorded.
Measured: Day 0 to day 14
Time to Normalization of White Blood Cell Count
White blood cell (WBC) count will be measured once daily. If patient presents with WBC count greater than 11.0 x 10^3/mL, time until patient has WBC less than 11.0 x 10^3/mL will be recorded.
Measured: Day to day 14
Clinical Failure of Treatment
Failure of treatment will be defined as patient needing I.V. antibiotics beyond the 14 days allowed in this study. The primary medical team (along with a blinded investigator) treating the patient will determine whether patient requires additional therapy.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Recruitment was not sufficient to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Biondo, PharmD, Principal investigator, West Virginia University Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694069
- Sponsor's protocol ID
- 24255
- Acronym
- PIPE-CF
- Status last verified
- Jan 2022
- First submitted
- 19 Sep 2012
- Last updated
- 1 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01694069
- Acronym / sponsor ID
- PIPE-CF / 24255
- Conditions
- Cystic Fibrosis
- Keywords
- piperacillin, tazobactam, pseudomonas aeruginosa, cystic fibrosis, pulmonary exacerbation, continuous infusion, beta lactam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was not sufficient to complete the study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Posted 1 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Infusion piperacillin-tazobactam | Active comparator | Drug: Piperacillin-tazobactam combination productPiperacillin-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 |
| Continuous infusion piperacillin-tazobactam | Experimental | Drug: Piperacillin-tazobactam combination productPiperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of cystic fibrosis
- 8 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin-tazobactam combination productAlso: Zosyn400 mg/kg/day as either intermittent or continuous infusion | Drug | Continuous infusion piperacillin-tazobactam, Intermittent Infusion piperacillin-tazobactam |
Primary outcome
Change in Forced Expiratory Volume at One Second (FEV1)
Time frame: Baseline, Day 0, and Day 14
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
8 secondary outcomes
Piperacillin Serum Concentrations
Time frame: Day 3
Time to Next Pulmonary Exacerbation
Time frame: Patients will be followed up to 52 weeks from time of enrollment
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
Time frame: Day 0 and day 14
Change in Sputum Density of Pseudomonas Aeruginosa
Time frame: Day 0, day 3, and day 14
Change in Weight
Time frame: Day 0 and day 14
Time to Defervescence
Time frame: Day 0 to day 14
Time to Normalization of White Blood Cell Count
Time frame: Day to day 14
Clinical Failure of Treatment
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Biondo, PharmD principal investigator
West Virginia University Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piperacillin-tazobactam combination product in people with Cystic Fibrosis, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume at One Second (FEV1) (time frame: Baseline, Day 0, and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.