Bacterial infections
Conditions
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Boy or girl between 3 months and 17 years of age, inclusive. - Suspected or diagnosed bacterial infection for which the patient is receiving standard antibiotic therapy - Otherwise healthy patients as confirmed by the investigator, after review of the subject's medical history, physical examination (including vital signs) and clinical laboratory tests - Subject's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age - Menarchal girls must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout study; have a negative urine or serum beta-human chorionic gonadotropin pregnancy test at screening. Are the trial subjects under 18? yes Number of subjects for this age range: 50 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
Exclusion criteria: - History of hypersensitivity (allergic reaction) reactions to carbapenems and penicillins or other beta lactam antibiotics - Known or suspected to have cystic fibrosis - History of hypersensitivity or intolerance to heparin, if an indwelling cannula (e.g., heparin lock) or central line is used - Known or suspected impairment of renal function - Patients concomitantly treated with or having received imipenem/cilastatin within 2 days before study drug administration - Patients concomitantly treated with probenecid or valproic acid -If a menarchal girl, is pregnant, is planning to become pregnant during the study, or is currently breastfeeding a child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the pharmacokinetics of doripenem and its metabolite, doripenem-M-1, in pediatric subjects 3 months to 17 years of age, inclusive.;Secondary Objective: The secondary objective is to evaluate safety and tolerability after doripenem administration.;Primary end point(s): The pharmacokinetics of doripenem and its metabolite, doripenem-M-1;Timepoint(s) of evaluation of this end point: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate safety and tolerability after doripenem administration;Timepoint(s) of evaluation of this end point: Day 1 to Day 7 | — |
Countries
United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed