Not provided
Not provided
Not provided
Not provided
Recruitment was not sufficient to complete the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin-tazobactam combination product | Drug | 400 mg/kg/day as either intermittent or continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Piperacillin Serum Concentrations | Serum piperacillin concentration will be measured as follows:
| Day 3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Biondo, PharmD | West Virginia University Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Healthcare | Morgantown | West Virginia | 26505 | United States |
Not provided
The study was terminated and the original PI has left the institution. Minimal results information is available; all efforts were made to retrieve more results information, but were unsuccessful. The available data does not indicate in which arm the participants were enrolled, therefore all available study data with be entered under All Study Participants.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Intermittent Infusion piperacillin-tazobactam and Continuous infusion piperacillin-tazobactam were combined into the All Study Participants, because the available study data was not separated into arms. Continuous infusion piperacillin-tazobactam: 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 Continuous infusion piperacillin-tazobactam: Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated and the original PI has left the institution. Minimal results information is available; all efforts were made to retrieve more results information, but were unsuccessful. The available data does not indicate in which arm the participants were enrolled, therefore all available study data with be entered under All Study Participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Intermittent Infusion piperacillin-tazobactam and Continuous infusion piperacillin-tazobactam were combined into the All Study Participants, because the available study data was not separated into arms. Continuous infusion piperacillin-tazobactam: 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 Continuous infusion piperacillin-tazobactam: Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | There was no available information about age of participants outside of that included in the inclusion criteria, indicating participants needed to be at least 8 years old to participate. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Baseline, Day 0, and Day 14 |
|
Not provided
The study was terminated and the original PI has left the institution. No adverse event information is available; all efforts were to made to retrieve adverse event information, but efforts were unsuccessful.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intermittent Infusion Piperacillin-tazobactam | 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 Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Compliance Coordinator | West Virginia Universtiy, WVCTSI | 304-293-0216 | ctgovadmin@hsc.wvu.edu |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 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 | 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 | Day 0, day 3, and day 14 |
| Change in Weight | The change in weight will be documented from enrollment to end of therapy | 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. | 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. | 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. | Day 14 |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Continuous Infusion Piperacillin-tazobactam | Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion |
|
| Secondary | Piperacillin Serum Concentrations | Serum piperacillin concentration will be measured as follows:
| The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Day 3 |
|
|
| Secondary | 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. | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Patients will be followed up to 52 weeks from time of enrollment |
|
|
| Secondary | 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 | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Day 0 and day 14 |
|
|
| Secondary | Change in Sputum Density of Pseudomonas Aeruginosa | Sputum density of Pseudomonas aeruginosa will be determined at enrollment, day 3, and at end of therapy | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Day 0, day 3, and day 14 |
|
|
| Secondary | Change in Weight | The change in weight will be documented from enrollment to end of therapy | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Day 0 and day 14 |
|
|
| Secondary | 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. | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Day 0 to day 14 |
|
|
| Secondary | 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. | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Day to day 14 |
|
|
| Secondary | 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. | The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful. | Posted | Day 14 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Continuous Infusion Piperacillin-tazobactam | Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily Piperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |