Clinical Trial Results:
Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset Sepsis
Summary
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EudraCT number |
2014-003243-34 |
Trial protocol |
HU ES IT LT |
Global end of trial date |
30 Dec 2017
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Results information
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Results version number |
v2(current) |
This version publication date |
01 Sep 2018
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First version publication date |
07 Jul 2018
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Other versions |
v1 |
Version creation reason |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C2661002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000769-PIP01-09 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Mar 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Dec 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the safety, tolerability, pharmacokinetics, and efficacy of Ceftaroline in neonates and young infants with late-onset sepsis.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and
in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP)
Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Aug 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 4
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Country: Number of subjects enrolled |
Hungary: 7
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Worldwide total number of subjects |
11
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
7
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Infants and toddlers (28 days-23 months) |
4
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||
Pre-assignment
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Screening details |
The study was conducted in the United States and Hungary from 04 August 2015 to 26 December 2017. A total of 11 subjects were enrolled. | ||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ceftaroline Fosamil: Young Infants | ||||||||||||||||||||
Arm description |
Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Ceftaroline fosamil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received Ceftaroline fosamil 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours for 48 hours to 14 days plus ampicillin IV for 48 hours minimum and optional aminoglycoside per local standard of care therapy.
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Investigational medicinal product name |
Ampicillin
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Investigational medicinal product code |
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Other name |
ampicillin
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Ampicillin IV is mandatory for 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Given per standard of care.
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Investigational medicinal product name |
Aminoglycoside
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Investigational medicinal product code |
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Other name |
aminoglycoside
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Aminoglycoside, given as standard of care therapy, is optional during the study as the discretion of the Investigator.
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Arm title
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Ceftaroline Fosamil: Term Neonates | ||||||||||||||||||||
Arm description |
Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Ceftaroline fosamil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received Ceftaroline fosamil 6 mg/kg over 60 minutes every 8 hours for 48 hours to 14 days plus ampicillin IV for 48 hours minimum and optional aminoglycoside per local standard of care therapy.
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Investigational medicinal product name |
Ampicillin
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Investigational medicinal product code |
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Other name |
ampicillin
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Ampicillin IV is mandatory for 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Given per standard of care.
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Investigational medicinal product name |
Aminoglycoside
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Investigational medicinal product code |
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Other name |
aminoglycoside
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Aminoglycoside, given as standard of care therapy, is optional during the study as the discretion of the Investigator.
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Arm title
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Ceftaroline Fosamil: Preterm Neonates | ||||||||||||||||||||
Arm description |
Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Ceftaroline fosamil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received Ceftaroline fosamil 6 mg/kg over 60 minutes every 8 hours for 48 hours to 14 days plus ampicillin IV for 48 hours minimum and optional aminoglycoside per local standard of care therapy.
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Investigational medicinal product name |
Ampicillin
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Investigational medicinal product code |
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Other name |
ampicillin
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Ampicillin IV is mandatory for 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Given per standard of care.
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Investigational medicinal product name |
Aminoglycoside
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Investigational medicinal product code |
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Other name |
aminoglycoside
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Aminoglycoside, given as standard of care therapy, is optional during the study as the discretion of the Investigator.
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Baseline characteristics reporting groups
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Reporting group title |
Ceftaroline Fosamil: Young Infants
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Reporting group description |
Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ceftaroline Fosamil: Term Neonates
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Reporting group description |
Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ceftaroline Fosamil: Preterm Neonates
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Reporting group description |
Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ceftaroline Fosamil: Young Infants
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Reporting group description |
Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||
Reporting group title |
Ceftaroline Fosamil: Term Neonates
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Reporting group description |
Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||
Reporting group title |
Ceftaroline Fosamil: Preterm Neonates
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Reporting group description |
Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||
Subject analysis set title |
Ceftaroline Fosamil: All Subjects
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside as per local standard of care, which was optional and could be started and stopped at any time during the study at the discretion of investigator.
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End point title |
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) [1] | ||||||||||||||||||||||||
End point description |
An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Safety analysis set consisted of all enrolled subjects for whom informed consent form was signed and received any amount of ceftaroline fosamil.
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End point type |
Primary
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End point timeframe |
Baseline up to SFU visit (up to a maximum study duration of 49 days)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not planned for this endpoint |
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No statistical analyses for this end point |
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End point title |
Plasma Concentration of Ceftaroline Fosamil | ||||||||||||||
End point description |
Data was not summarized and provided for individual subjects only and reported in this end point for only those subjects who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL). Pharmacokinetic (PK) analysis set included all subjects who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
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End point type |
Secondary
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End point timeframe |
At the end of infusion (EOI)
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No statistical analyses for this end point |
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End point title |
Plasma Concentration of Ceftaroline | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual subjects only and reported in this end point for only those subjects who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL. The PK analysis set included all subjects who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
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End point type |
Secondary
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End point timeframe |
At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI
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No statistical analyses for this end point |
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End point title |
Plasma Concentration of Ceftaroline M-1 | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual subjects only and reported in this end point for only those subjects who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL The PK analysis set will include all subjects who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
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End point type |
Secondary
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End point timeframe |
At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Favorable Clinical Response | ||||||||||||||||||||||||
End point description |
Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure, defined as resolution of all acute signs and symptoms of Late-onset sepsis (LOS) or improvement to such an extent that no further antibacterial therapy is required. Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the subject was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required) EOT visit occurred within 24 hours after the end of last infusion. Modified ITT analysis set: subjects who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis.
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End point type |
Secondary
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End point timeframe |
EOT visit (within 24 hours after the end of infusion), TOC visit (8 to 15 days after last dose of study drug)
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Favorable Microbiological Response | ||||||||||||||||||||||||
End point description |
Microbiological response was determining programmatically and assessed at the subject level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (subject's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the subject was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required) EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug. Analyzed in the mITT set.
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End point type |
Secondary
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End point timeframe |
EOT visit (within 24 hours after the end of infusion), TOC visit (8 to 15 days after last dose of study drug)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to SFU visit (up to a maximum study duration of 49 days)
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Adverse event reporting additional description |
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Ceftaroline Fosamil: Young Infants
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Reporting group description |
Young infants aged > 28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ceftaroline Fosamil: Term Neonates
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Reporting group description |
Term neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ceftaroline Fosamil: Preterm Neonates
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Reporting group description |
Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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16 Dec 2015 |
The dose of ceftaroline fosamil to be given was increased to 6 mg/kg. |
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25 Aug 2016 |
Inclusion criterion was revised so that subjects must only meet at least 1 of the listed laboratory criteria, rather than 2. |
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25 May 2017 |
Safety follow-up visit window changed to 28 - 35 days. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |