Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:4/21/2016
Start Date:September 2014
End Date:November 2016
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

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

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a
single intravenous dose of ceftolozane/tazobactam in pediatric participants.

Ceftolozane/tazobactam is a novel antibacterial consisting of ceftolozane, a unique
antipseudomonal cephalosporin, with tazobactam, a well-established β-lactamase inhibitor.

This is the first study investigating the use of ceftolozane/tazobactam in pediatric
participants.

Screening assessments will occur within 48 hours of study drug administration (Day 1).
Baseline assessments will be performed following eligibility verification based on screening
assessments.

Participants will be monitored for safety 24 hours post study drug infusion. The site will
contact the participant and/or parent (or appropriate legal representative) via telephone at
Study Day 8 (± 2 days) for assessment of adverse events and concomitant medications and
procedures.

In each age cohort, an interim analysis of PK and safety data will be conducted after 3
participants have received the initially proposed dose. The interim analysis will determine
whether this initial dose was appropriate based on pre-defined criteria.

If data from the interim analysis demonstrates that the initially proposed dose meets the
criteria above, enrollment will continue with the same dose administered to 3 additional
participants. However, if the interim analysis demonstrates that a new optimized adjusted
dose is required, the new adjusted dose will be administered to 3 new participants of the
same age range. In subsequent cohorts, the initial dose is also subject to change based upon
the results of the interim analysis in previous cohorts.

Key Inclusion Criteria:

1. Males or non-pregnant females from birth to <18 years of age

2. Receiving standard of care antibiotic therapy for suspected or diagnosed
Gram-negative infection or for peri-operative prophylaxis

3. Groups 1-4: Calculated creatinine clearance rate (CLCR) ≥ 80 ml/min/1.73m2 at
baseline

4. Group 5: CLCR ≥ 50 ml/min/1.73m2 at baseline

5. Group 6: CLCR ≥ 20 ml/min/1.73m2 at baseline

Key Exclusion Criteria:

1. Known allergy/hypersensitivity to any β-lactam antibacterial

2. History of clinically significant renal, hepatic, or hemodynamic instability

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

6. Receipt of piperacillin/tazobactam within 24 hours of study drug administration

7. Likely to be at risk of hemodynamic disturbance following collection of the required
PK blood samples
We found this trial at
17
sites
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials