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

NCT01366651 | Terminated Phase 1

• 3 other identifiers: CR016189DORIPED10022011-001114-33
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningitis

Keywords

Doripenem; DORIPED1002; Intravenous; Pediatric; Antibiotic; Meningitis

Outcome Measures

Primary Outcomes (1)

• Doripenem concentrations in CSF and plasma

  For up to 2 days

Secondary Outcomes (7)

• Number of patients with adverse events

  Up to Day 9

• Changes in clinical laboratory test results

  From Day -1 to Day 9

• Changes in physical examination results reported as adverse events

  From Day -1 to Day 9

• Changes in vital signs measurements

  From Day -1 to Day 9

• Changes in concomitant therapy

  From Day -1 to Day 9

Study Arms (1)

Doripenem

EXPERIMENTAL

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

Interventions

Doripenem DRUG

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

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Leuven, Belgium

Location

Related Links

• 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

MeSH Terms

Conditions

Meningitis

Interventions

Doripenem

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Development, L.L.C., Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: June 6, 2011
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

BE (1)