A Phase 1 interventional study of Doripenem and Doripenem in Meningitis, sponsored by Janssen Research & Development, LLC. Terminated at 1 site in Belgium. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2013-12-06.
Sponsored by Janssen Research & Development, LLC · Phase 1 and Interventional
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.
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.
373 studies on the registry are indexed under Meningitis; 32 are open to participants now.
This study's enrollment of 1 is below the median of 211 across 257 interventional studies indexed under Meningitis.
Browse Meningitis studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Exclusion Criteria:
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.
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 concentrations in CSF and plasma
Time frame: For up to 2 days
Number of patients with adverse events
Time frame: Up to Day 9
Changes in clinical laboratory test results
Time frame: From Day -1 to Day 9
Changes in physical examination results reported as adverse events
Time frame: From Day -1 to Day 9
Changes in vital signs measurements
Time frame: From Day -1 to Day 9
Changes in concomitant therapy
Time frame: From Day -1 to Day 9
The number of patients with changes from baseline in clinical laboratory test results
Time frame: From Day -1 to Day 9
The number of patients who receive concomitant therapy
Time frame: From Day -1 to Day 9
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC