E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027202 |
E.1.2 | Term | Meningitis bacterial |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the penetration of doripenem in
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
LP or VP shunt tap. |
|
E.2.2 | Secondary objectives of the trial |
Safety and tolerability will also be assessed |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-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 |
|
E.4 | Principal exclusion criteria |
-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). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Doripenem concentrations in CSF and plasma |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Number of patients with adverse events
-Changes in clinical laboratory test results
-Changes in physical examination results reported as adverse events
-Changes in vital signs measurements
-Changes in concomitant therapy
-The number of patients with changes from baseline in clinical laboratory
test results
-The number of patients who receive concomitant therapy |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Up to Day 9
-From Day -1 to Day 9
-From Day -1 to Day 9
-From Day -1 to Day 9
-From Day -1 to Day 9
-From Day -1 to Day 9
-From Day -1 to Day 9
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 15 |