A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age

This study has been terminated.
(Trial terminated early per business decision.)
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01366651
First received: April 14, 2011
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics.


Condition Intervention Phase
Meningitis
Drug: Doripenem
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 Year Chronological Age

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Doripenem concentrations in CSF and plasma [ Time Frame: For up to 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Up to Day 9 ] [ Designated as safety issue: No ]
  • Changes in clinical laboratory test results [ Time Frame: From Day -1 to Day 9 ] [ Designated as safety issue: No ]
  • Changes in physical examination results reported as adverse events [ Time Frame: From Day -1 to Day 9 ] [ Designated as safety issue: No ]
  • Changes in vital signs measurements [ Time Frame: From Day -1 to Day 9 ] [ Designated as safety issue: No ]
  • Changes in concomitant therapy [ Time Frame: From Day -1 to Day 9 ] [ Designated as safety issue: No ]
  • The number of patients with changes from baseline in clinical laboratory test results [ Time Frame: From Day -1 to Day 9 ] [ Designated as safety issue: No ]
  • The number of patients who receive concomitant therapy [ Time Frame: From Day -1 to Day 9 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doripenem
Doripenem Type=exact number unit=mg/kg number=10 form=solution for injection route=intravenous use every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age.Doripenem 500-mg sterile powder will be supplied for the study in single use glass vials.,Doripenem Type=exact number unit=mg/kg number=30 form=solution for injection route=intravenous use every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age. Doripenem 500-mg sterile powder will be supplied for the study in single use glass vials.
Drug: Doripenem
Type=exact number, unit=mg/kg, number=30, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age.
Drug: Doripenem
Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age.

Detailed Description:

This is a multicenter, open-label (identity of treatment is known to patient's parent/legal guardian/caregiver and to all study staff) study to characterize the penetration of doripenem in the cerebral spinal fluid (CSF) in pediatric patients <1 year of age who are hospitalized but medically stable, and who have a documented or suspected infection and are planning to, or undergoing treatment with antibiotics administered intravenously (in a vein, abbreviated as "IV"). Doripenem will not replace the patients' prescribed antibiotic(s). The study includes 3 phases: a pretreatment phase consisting of an up to 24-hour screening period; a 2-day open-label treatment period when doripenem will be administered, and CSF and blood samples will be collected, and a follow-up visit approximately 1 week after administration of the last dose of doripenem. The total duration of the study is approximately 10 days. During the study, patients <12 weeks of age will receive a 10 mg/kg doripenem 1-hour IV infusion via a central or peripheral venous line (a catheter inserted in a large vein) every 8 hours; patients 12 weeks to <1 year of age will receive a 30 mg/kg doripenem 1-hour IV infusion every 8 hours. A total of 5 doses of doripenem will be administered over a 2-day period while the patient is in the hospital.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is expected to require hospitalization for the entire open-label phase of the study.
  • Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a "spinal tap") or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.
  • Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV antibiotics.
  • Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study.

Exclusion Criteria:

  • Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.
  • Any condition at screening that, in the opinion of the investigator, may interfere with the assessments of this study.
  • Patients with substantially compromised renal (kidney) function: e.g., urine output is <0.25cc/kg/hr within the 24 hours before screening.
  • History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.
  • Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.
  • Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration.
  • Patients concomitantly treated with probenecid or valproic acid (VPA).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366651

Locations
Belgium
Leuven, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Development, L.L.C., Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01366651     History of Changes
Other Study ID Numbers: CR016189, DORIPED1002, 2011-001114-33
Study First Received: April 14, 2011
Last Updated: December 4, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Janssen Research & Development, LLC:
Doripenem
DORIPED1002
Intravenous
Pediatric
Antibiotic
Meningitis

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014