Pharmacokinetics and Safety of Doripenem in hospitalized Pediatric Patients from 3 Months to 17 Years of Age

• Conditions: Bacterial infections; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-005159-15-Outside-EU/EEA
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 50

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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