E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bacterial Infection in hospitalized children |
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E.1.1.1 | Medical condition in easily understood language |
Bacterial Infection in children |
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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 | 10004044 |
E.1.2 | Term | Bacterial infection NOS |
E.1.2 | System Organ Class | 100000004862 |
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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 characterize the pharmacokinetics (PK) of dalbavancin in pediatric patients aged gestational age 32 weeks to 3 months following the intravenous administration of a single dose of dalbavancin |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of a single dalbavancin IV infusion |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Hospitalized male and female patients who are preterm neonates (gestational age ≥32 to <37 weeks, aged ≤28 days), term neonates (gestational age ≥37 weeks, aged ≤28 days) or young infants (aged 28 days to <3 months inclusive) who will be receiving at least 24 hours of appropriate noninvestigational intravenous antiinfective treatment other than glycopeptide antibiotics for known or suspected bacterial infections. Patients with urinary tract infections due to Gram-positive organisms may be enrolled
Each patient's parent(s)/legal guardian(s) must be willing and able to provide a signed and dated written informed consent document indicating that they have been informed of all pertinent aspects of the trial
Each patient's parent(s)/legal guardian(s) must be willing and able, if patient is discharged from the hospital, to return the patient to the hospital or a designated clinic for scheduled visits, or allow a nurse to come to the patient's home for laboratory tests, PK and other outpatient procedures as required by the protocol
Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study
Sufficient intravenous access (peripheral or central) to receive Investigational Product (IP)
Patients must have an audiologic assessment within 7 days prior to the investigational product infusion consisting of ear specific hearing testing utilizing distortion product evoked otoacoustic emissions, acoustic immittance measures, and (optional) auditory brainstem response testing. |
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E.4 | Principal exclusion criteria |
Treatment with an investigational drug within 30 days preceding the dose of IP
Patients who are currently receiving intravenous vancomycin or other glycopeptide antibiotics. Dalbavancin may be administered 8 hours after the last dose of vancomycin. Vancomycin or other glycopeptide antibiotics should not be given during the 7 day period following administration of dalbavancin. If intravenous vancomycin or other glycopeptide use is unavoidable during the 7 day period following administration of dalbavancin, this should be documented as a concomitant medication
Have aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin level > 3 times upper limit of normal (neonates with elevated total bilirubin could participate if conjugated bilirubin was normal)
Albumin < half lower limit of normal
Have received a blood or blood component (eg, red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before dosing
Have any condition (eg. Septic shock, burns, cystic fibrosis, acute hemodynamic instability including those conditions requiring pressor support) that would make the patient, in the opinion of the Investigator, unsuitable for the study (eg, would place the patient at risk, compromise the quality of the data; or interfere with the absorption, distribution, metabolism or excretion of dalbavancin)
Patients known to have hypersensitivity to glycopeptides
Moderate or severe renal impairment defined as serum creatinine ≥2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis)
Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma concentration of dalbavancin
Number of patients experiencing a treatment emergent adverse event |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Plasma concentration of dalbavancin - Day 1, Day 2, Day 5-9 and Day 24-32
Number of patients experiencing a treatment emergent adverse event - Baseline (Day 1) up to Day 35 |
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E.5.2 | Secondary end point(s) |
Maximum plasma drug concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
Apparent total body clearance (CL) of drug from plasma
Apparent volume of distribution volume of distribution (V)
Terminal elimination half-life (T1/2). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1, Day 2, Day 5-9 and Day 24-32 |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 |
A Study in a Paediatric Population |
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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.8.3 |
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 | 3 |