E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
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 assess the pharmacokinetics of doripenem and its metabolite, doripenem-M-1, in pediatric subjects 3 months to 17 years of age, inclusive. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate safety and tolerability after doripenem administration. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The pharmacokinetics of doripenem and its metabolite, doripenem-M-1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
To evaluate safety and tolerability after doripenem administration |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 |
First administration to pediatric patients (3 months to 17 years of age) |
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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 | No |
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 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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
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End of trial is last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
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 | 6 |