A Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis

• Conditions: This study is designed to assess the PK, safety, and tolerability of a single intravenous dose ofceftolozane/tazobactam in pediatric patients.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003485-24-Outside-EU/EEA
• Lead Sponsor: Cubist Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-25
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 36

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 <18 years of age;
3. Able to comply with the protocol for the duration of the study;
4. For female patients who have undergone menarche:
• Is not pregnant (as confirmed by the serum pregnancy test at Screening) and not planning to become pregnant within 30 days of last study drug administration,
AND
• Is non-lactating, AND
• Is abstinent OR utilizes one of the following for at least 1 month prior to screening: hormonal contraceptives (injectable, oral, patch, or vaginal ring),
intrauterine device (IUD), or barrier method (diaphragm). This method must be used in combination with a barrier method of contraception for their male partner
(condom). Patients must be willing to practice these methods for at least 30 days after study drug administration;
5. For male patients who are sexually active with female partners who have undergone menarche: patient must be using and willing to continue using medically acceptable forms
of contraception (abstinence, or male condom for patients plus an additional method of contraception for their female partners) from Screening and for at least 30 days after study drug administration;
6. Receiving standard of care intravenous antibiotic therapy for suspected or diagnosed Gram-negative infection or for peri-operative prophylaxis; and
7. Have a calculated creatinine clearance rate (CLCR) = 80 ml/min/1.73m2 as determined by the Schwartz (2009) equation at baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified