E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is designed to assess the PK, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric patients. |
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E.1.1.1 | Medical condition in easily understood language |
This study is designed to assess the PK, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric patients. |
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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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018657 |
E.1.2 | Term | Gram-negative bacterial infection NOS |
E.1.2 | System Organ Class | 100000004862 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049086 |
E.1.2 | Term | Antibacterial prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To evaluate the pharmacokinetics (PK) of a single dose of intravenous ceftolozane/tazobactam in pediatric patients from birth to <18 years receiving standard of care antibiotic therapy for proven or suspected Gram-negative infection, including patients receiving peri-operative prophylactic antibiotics. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of a single dose of intravenous ceftolozane/tazobactam in pediatric patients from birth to <18 years receiving standard of care antibiotic therapy for proven or suspected Gram-negative infection, including patients receiving peri-operative prophylactic antibiotics. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Males or non-pregnant females from birth to <18 years of age
2.Receiving standard of care antibiotic therapy for suspected or diagnosed Gram-negative infection or for peri-operative prophylaxis
3.Groups 1-4: Calculated creatinine clearance rate (CLCR) ≥ 80 ml/min/1.73m2 at baseline
4.Group 5: CLCR ≥ 50 ml/min/1.73m2 at baseline
5.Group 6: CLCR ≥ 20 ml/min/1.73m2 at baseline
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E.4 | Principal exclusion criteria |
1.Known allergy/hypersensitivity to any β-lactam antibacterial
2.History of clinically significant renal, hepatic, or hemodynamic instability
3.Planned use of cardiopulmonary bypass or dialysis
4.Planned blood transfusion within 24 hours of study drug administration
5.Clinically significant abnormal laboratory test results not related to the underlying infection
6.Receipt of piperacillin/tazobactam within 24 hours of study drug administration
7.Likely to be at risk of hemodynamic disturbance following collection of the required PK blood samples
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Maximum plasma concentration (Cmax) of ceftolozane/tazobactam
2.Time to Cmax (Tmax) of ceftolozane/tazobactam
3.Concentration at last sampling point (Clast) of ceftolozane/tazobactam
4.Time of last sampling point (Tlast) of ceftolozane/tazobactam]
5.Area under the plasma concentration-time curve from 0 to time of last sample collected (AUC0-tlast) of ceftolozane/tazobactam
6.Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of ceftolozane/tazobactam
7.Elimination half-life (t1/2) of ceftolozane/tazobactam
8.Volume of distribution at steady state (Vss) of ceftolozane/tazobactam
9.Plasma clearance (CL) of ceftolozane/tazobactam
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. and 2.: Assessed up to 6 hours after the start of study drug administration.
3 to 9.: Assessed at 0, 0.5, 1, 2, 4, and 6 hours after the start of study drug administration.
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E.5.2 | Secondary end point(s) |
1.Number of participants with one or more Adverse Events
2.Number of participants who discontinued study due to an Adverse Event
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.Participants will be followed from the time of study drug administration (study day 1) through the last study follow up (may occur up to study day 10).
2.Participants will be followed on the day of study drug administration (study 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 |
PK, safety and tolerabilty in paediatric patients |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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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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 | 10 |