E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
documented or presumed bacterial infections, or at risk of a bacterial infection |
|
E.1.1.1 | Medical condition in easily understood language |
possible or definitely a bacterial infection |
|
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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010120 |
E.1.2 | Term | Community acquired pneumonia |
E.1.2 | System Organ Class | 100000004862 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052596 |
E.1.2 | Term | Nosocomial pneumonia |
E.1.2 | System Organ Class | 100000004862 |
|
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 is to characterize the pharmacokinetics of a single dose of ceftobiprole in neonates and infants aged up to 3 months. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the safety and tolerability of ceftobiprole in neonates and infants aged up to 3 months. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Neonates and infants up to 3 months, with gestational age ≥ 28 weeks
- Documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment
- Expected to survive beyond the first 7 days after enrolment
- Sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site
- Parent’s / legally acceptable representative’s informed consent to participate in the study |
|
E.4 | Principal exclusion criteria |
· Major birth defect or malformation syndrome
· Proven presence of an immunodeficiency
· HIV or other congenital viral or fungal infection
· Significant laboratory abnormalities
· Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) less than 2/3 of normal for the applicable age group
· Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Analyse plasma and urine for concentrations of ceftobiprole, and if applicable for concentrations of ceftobiprole medocaril and the open-ring metabolite (BAL1029). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
−2 to 0 h
−15 min
Pre dose
0 to 2 h
1 h
2 h
2 h 15 min
2 to 4 h
4 h (end of infusion)
4 to 8h
6h
8h
8 to 12h
12h
|
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 |
Single-Dose Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants Aged up to 3 M |
|
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Germany |
Latvia |
Lithuania |
Poland |
United States |
|
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 | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |