E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hospitalized but medically stable infants (term and preterm), <12 weeks CA, who have documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics. |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004044 |
E.1.2 | Term | Bacterial infection NOS |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 pharmacokinetics of doripenem after single-dose administration of doripenem to infants (term and preterm), <12 weeks chronological age (CA). Safety and tolerability will also be assessed. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Must be hospitalized, medically stable, without acute decline in physical condition in the inestigator's judgement
• Documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics
• Patient's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age
• 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 |
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E.4 | Principal exclusion criteria |
• Clinically significant abnormal values for hematology or clinical chemistry at screening as deemed appropriate by the investigator
• Clinically significant abnormal physical examination or vital signs at screening, as deemed appropriate by the investigator
• Patients who, in the investigator's judgment, have compromised renal (kidney) function including renal failure
• 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 indwelling 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Doripenem concentrations in blood samples |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before and after study drug administration for 1 day |
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E.5.2 | Secondary end point(s) |
1 - Number of patients with adverse events
2 - Changes in clinical laboratory test results
3 - Changes in vital signs measurements |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 - Up to Day 7
2 - From Day -2 to Day 1
3 - From Day -2 to Day 1 |
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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 |
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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 | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Belgium |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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Last vist 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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 1 |