A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age
- Conditions
- MeningitisMedDRA version: 14.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-001114-33-BE
- Lead Sponsor
- Janssen-Cilag International NV,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
-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
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
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
-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).
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 evaluate the penetration of doripenem in<br>cerebrospinal fluid (CSF) after administration of doripenem to pediatric subjects less than 1 year of age with or without a ventriculoperitoneal (VP) shunt who are scheduled for a<br>LP or VP shunt tap. ;Secondary Objective: Safety and tolerability will also be assessed;Primary end point(s): Doripenem concentrations in CSF and plasma;Timepoint(s) of evaluation of this end point: For up to 2 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Number of patients with adverse events<br>-Changes in clinical laboratory test results<br>-Changes in physical examination results reported as adverse events<br>-Changes in vital signs measurements<br>-Changes in concomitant therapy<br>-The number of patients with changes from baseline in clinical laboratory<br>test results<br>-The number of patients who receive concomitant therapy;Timepoint(s) of evaluation of this end point: -Up to Day 9<br>-From Day -1 to Day 9<br>-From Day -1 to Day 9<br>-From Day -1 to Day 9<br>-From Day -1 to Day 9<br>-From Day -1 to Day 9<br>-From Day -1 to Day 9<br>