Clinical Trial Results:
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
Summary
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EudraCT number |
2011-003812-22 |
Trial protocol |
Outside EU/EEA LT LV ES PL |
Global end of trial date |
13 May 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Aug 2018
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First version publication date |
09 Aug 2018
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Other versions |
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 |
P903-23
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01400867 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Cerexa, Inc (a subsidiary of Allergan, plc)
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Sponsor organisation address |
185 Hudson Street, Plaza 5, Jersey City, United States, NJ 07302-3908
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Public contact |
Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, khaeckl@cerexa.com
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Scientific contact |
Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, khaeckl@cerexa.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? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Nov 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 May 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
13 May 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with acute bacterial skin and skin structure infections (ABSSSI)
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. Written informed consent from parent or legally acceptable representative and verbal informed assent from subject (if age appropriate and according to local requirements) were obtained before initiating study-related assessments or procedures.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Nov 2011
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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 |
Poland: 19
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Country: Number of subjects enrolled |
Spain: 12
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Country: Number of subjects enrolled |
Latvia: 21
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Country: Number of subjects enrolled |
Lithuania: 12
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Country: Number of subjects enrolled |
Argentina: 14
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Country: Number of subjects enrolled |
Chile: 14
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Country: Number of subjects enrolled |
United States: 33
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Country: Number of subjects enrolled |
South Africa: 7
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Country: Number of subjects enrolled |
Georgia: 31
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Worldwide total number of subjects |
163
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EEA total number of subjects |
64
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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) |
0
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Infants and toddlers (28 days-23 months) |
39
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Children (2-11 years) |
87
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Adolescents (12-17 years) |
37
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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 |
A total of 163 subjects between the ages of 2 months to < 18 years, with acute bacterial skin and skin structure infections (ABSSSI) were enrolled in the study. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind [1] | ||||||||||||||||||||||||
Roles blinded |
Investigator, Assessor [2] | ||||||||||||||||||||||||
Blinding implementation details |
At each study centre, at least 1 blinded investigator (“Blinded Observer”) did not know the subject’s treatment assignment and conducted clinical assessments (including efficacy and safety).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ceftaroline fosamil | ||||||||||||||||||||||||
Arm description |
110 subjects were randomized (ITT) to receive a minimum of 7 IV doses of ceftaroline fosamil (a minimum of 3 days of IV therapy). A switch to open-label oral study drug (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol-specified criteria. The total duration of IV plus PO therapy was 5 to 14 days. | ||||||||||||||||||||||||
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 |
Powder for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
IV ceftaroline fosamil was infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) as follows:
Children ≥ 6 months: ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg
Children < 6 months: ceftaroline fosamil 8 mg/kg
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Arm title
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Comparator | ||||||||||||||||||||||||
Arm description |
53 subjects were randomized (ITT) to receive vancomycin or cefazolin with or without aztreonam for a minimum of 3 days of IV therapy. A switch to open-label oral study drug (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol specified criteria. The total duration of IV plus PO therapy was 5 to 14 days. | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Vancomycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) was infused over at least 60 minutes (or at a maximum of 10 mg/min, whichever was longer).
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Investigational medicinal product name |
Cefazolin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
IV cefazolin 75 mg/kg/day divided q8h (± 1 hour) was infused over 60 (± 10) minutes.
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Investigational medicinal product name |
Aztreonam
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
IV aztreonam 30 mg/kg q8h (± 1 hour) was infused over 60 (± 10) minutes, at any time during IV therapy if an infection involving a Gram-negative pathogen was identified or suspected.
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Notes [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial. Justification: This study was observer-blinded. At each study centre, at least 1 blinded investigator did not know the subject’s treatment assignment and conducted clinical assessments (including efficacy and safety). [2] - The roles blinded appear inconsistent with a simple blinded trial. Justification: This study was observer-blinded. At each study centre, at least 1 blinded investigator did not know the subject’s treatment assignment and conducted clinical assessments (including efficacy and safety). |
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Ceftaroline - Safety Set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety Population consists of all patients received any amount of IV study drug.
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Subject analysis set title |
Comparator - Safety Set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety Population consists of all patients received any amount of IV study drug.
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Subject analysis set title |
Ceftaroline - MITT Set
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.
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Subject analysis set title |
Comparator - MITT Set
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.
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Subject analysis set title |
Ceftaroline - Clinically Evaluable Set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet minimal ABSSSI disease criteria and all evaluability criteria.
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Subject analysis set title |
Comparator - Clinically Evaluable Set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet the minimal ABSSSI disease criteria and all evaluability criteria.
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End points reporting groups
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Reporting group title |
Ceftaroline fosamil
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Reporting group description |
110 subjects were randomized (ITT) to receive a minimum of 7 IV doses of ceftaroline fosamil (a minimum of 3 days of IV therapy). A switch to open-label oral study drug (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol-specified criteria. The total duration of IV plus PO therapy was 5 to 14 days. | ||
Reporting group title |
Comparator
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Reporting group description |
53 subjects were randomized (ITT) to receive vancomycin or cefazolin with or without aztreonam for a minimum of 3 days of IV therapy. A switch to open-label oral study drug (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol specified criteria. The total duration of IV plus PO therapy was 5 to 14 days. | ||
Subject analysis set title |
Ceftaroline - Safety Set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Population consists of all patients received any amount of IV study drug.
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Subject analysis set title |
Comparator - Safety Set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Population consists of all patients received any amount of IV study drug.
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Subject analysis set title |
Ceftaroline - MITT Set
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
The Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.
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Subject analysis set title |
Comparator - MITT Set
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
The Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.
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Subject analysis set title |
Ceftaroline - Clinically Evaluable Set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet minimal ABSSSI disease criteria and all evaluability criteria.
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Subject analysis set title |
Comparator - Clinically Evaluable Set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet the minimal ABSSSI disease criteria and all evaluability criteria.
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End point title |
Extent of Exposure - Safety Set [1] | ||||||||||||||||||||||||
End point description |
Extent of Exposure is described as number of Calendar Days subjects received ceftaroline or comparator (IV or Oral).
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End point type |
Primary
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End point timeframe |
The Extent of Exposure was evaluated from the date of the first dose of specified study drug to the date of the last dose of specified study drug + 1 day.
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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: This was an exploratory study with an emphasis on safety and was not powered for comparative inferential analysis. |
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No statistical analyses for this end point |
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End point title |
Adverse Events - Safety Set [2] | ||||||||||||||||||||||||||||||
End point description |
The safety assessment includes monitoring of adverse events, serious adverse events, deaths, and discontinuations due to AEs, including cephalosporin class effects and additional AEs.
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End point type |
Primary
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End point timeframe |
Adverse Events (AEs) were evaluated from signing of the ICF through LFU visit (21 to 35 days after last dose of any study drug [IV or PO]). Cephalosporin class effects and additional AEs were closely monitored/followed until resolution or stabilization.
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Notes [2] - 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: This is an exploratory study with an emphasis on safety and is not powered for inferential statistical analysis. |
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No statistical analyses for this end point |
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End point title |
Clinical Response at Study Day 3 - MITT Set | ||||||||||||||||||
End point description |
Clinical Response at Day 3 is defined as ≥ 20% reduction from baseline in infection area (length × width).
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End point type |
Secondary
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End point timeframe |
Clinical Response at Study Day 3 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 3.
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No statistical analyses for this end point |
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End point title |
Clinical Response at Study Day 3 - MITT Set | ||||||||||||||||||
End point description |
Clinical response at Study Day 3 was measured by cessation of spread relative to baseline as measured by area.
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End point type |
Secondary
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End point timeframe |
Clinical Response at Study Day 3 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 3.
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No statistical analyses for this end point |
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End point title |
Clinical Response at Study Day 3 - MITT Set | ||||||||||||||||||
End point description |
Clinical Response was measured by cessation of spread relative to baseline as measured by length and width, separately, AND temperature < 37.6°C, on Study Day 3, irrespective of temperature collection method.
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End point type |
Secondary
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End point timeframe |
Clinical Response at Study Day 3 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 3.
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No statistical analyses for this end point |
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End point title |
Clinical Outcome at TOC - MITT Set | ||||||||||||||||||
End point description |
Clinical Outcome at TOC is defined as assessment of clinical cure, clinical failure and indeterminate for the MITT population at Test-Of-Cure.
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End point type |
Secondary
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End point timeframe |
Clinical Outcome at Test-of-Cure (TOC) was evaluated 8 to 15 days after administration of the last dose of any study drug [IV or PO].
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No statistical analyses for this end point |
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End point title |
Clinical Outcomes at TOC - Clinically Evaluable Set | |||||||||||||||
End point description |
Clinical Outcome at TOC is defined as assessment of clinical cure, clinical failure and indeterminate for the Clinically Evaluable population at Test-of-Cure.
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End point type |
Secondary
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End point timeframe |
Clinical Outcomes at Test-of-Cure (TOC) were evaluated 8 to 15 days after the last dose of any study drug [IV or PO].
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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 |
21 to 35 days after last dose of any study drug [IV or PO]). If the LFU was conducted < 30 days after the last dose of study drug or was not conducted, AE/SAE information is obtained by telephone 30 days after the last dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Ceftaroline - Safety Population
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Reporting group description |
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Reporting group title |
Comparator - Safety Population
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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23 Aug 2011 |
The following changes were implemented with Amendment 1: removal of the requirement for ABSSSI specimens to be collected on all subjects; revision of the dosing regimen for study drug and PK sampling schedule. In addition, minor changes were made for clarity, consistency, and/or accuracy. |
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17 Apr 2012 |
The following changes were implemented with Amendment 2: addition of linezolid as a second option for PO study drug therapy; addition of the option for subjects who start the study on intravenous (IV) vancomycin and for whom no MRSA is identified to switch to IV cefazolin; addition of a clinical laboratory assessment time point and test to further evaluate safety; updates dosing regimen for cohorts and other clarifications. In addition, minor changes were made for clarity, consistency, and/or accuracy. |
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20 Sep 2012 |
The following changes were implemented with Amendment 3: addition of dosing information for Cohort 4; removal of the requirement for 3 days of hospitalization for enrolment; change in outpatient parenteral antimicrobial therapy (OPAT) criteria for clarification and modification of the lesion area and margin calculations requirements. In addition, minor changes were made for clarity, consistency, and/or accuracy. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
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 |