This study is designed to assess the PK, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric patients.
Conditions
Interventions
Product Name: ceftolozane/tazobactam
Product Code: CXA-201
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Cubist Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for enrollment, a patient must fulfill all of the following inclusion criteria: 1. Provide written parental (or appropriate legal representative) informed consent and age appropriate assent prior to any study-related procedure not part of normal medical care; 2. Male or female from birth (defined as at least 7 days postnatal) to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for enrollment, a patient must not meet any of the following exclusion criteria: 1. Known allergy/hypersensitivity to any ß-lactam antibacterial; 2. History of clinically significant renal, hepatic, or hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure in the 24-hour window prior to enrollment); 3. Planned use of cardiopulmonary bypass or dialysis; 4. Planned blood transfusion within 24 hours of study drug administration; 5. Clinically significant abnormal laboratory test results not related to the underlying infection, as determined by Investigator; 6. Height or weight outside of the 5th to 95th percentile; 7. Receipt of piperacillin/tazobactam within 24 hours of study drug administration; 8. Use of any medications known to inhibit tubular secretion of renally-excreted drugs; 9. Known use of illicit drugs or abuse of alcohol or cigarettes; 10. Patients likely to be at risk of hemodynamic disturbance (as determined by Investigator) following collection of the required PK blood samples; 11. Use of any investigational drug or participation in any experimental procedure in the 30 days preceding study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetics (PK) of a single dose of intravenous ceftolozane/tazobactam in pediatric patients from birth to 3 months of age), samples will be collected at up to the following six time points: pre-dose (0 hour) and at 0.5, 1, 2, 4, and 6 hours after the start of the infusion. For patients in Groups 5-6 (<3 months of age), samples will be collected at up to the following three time points: 1, 2, and 6 hours after the start of the infusion. For the 1 h post start of infusion time point, PK blood samples should be taken following flushing of the line (as per standard of care). Patients will be monitored for safety 24 hours post study-drug infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The safety and tolerability of single doses of IV ceftolozane/tazobactam in pediatric patients will be evaluated in the Safety population. The safety evaluation will be based on clinical review of the following safety parameters: • Incidence of AEs and SAEs • AEs and SAEs by relationship to study drug • AEs and SAEs by severity • Deaths • Premature discontinuation from the study due to an AE, regardless of relationship to study medication; • Clinical laboratory data; • Vital signs; • Concomitant medications;Timepoint(s) of evaluation of this end point: Patients will be monitored for safety 24 hours post study-drug infusion, including assessments of adverse events (AEs), physical examination, vital signs, and clinical laboratory tests. The site will contact the patient and/or parent (or appropriate legal representative) at Study Day 8 (± 2 days) for assessment of AEs and concomitant medications and procedures. | — |
Countries
United States
Contacts
Public ContactThomas Feinberg
Cubist Pharmaceuticals, Inc.
Outcome results
None listed