Clinical Trial Results:
A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus
Summary
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EudraCT number |
2012-002182-35 |
Trial protocol |
ES HU PL |
Global end of trial date |
03 Dec 2013
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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 |
P903-25
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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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, New Jersey, 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, IR-CTRegistration@allergan.com
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Scientific contact |
Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, IR-CTRegistration@allergan.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Sep 2014
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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 |
03 Dec 2013
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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 |
• Evaluate the efficacy of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)
• Evaluate the safety of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with CABP at risk for infection due to MRSA
• Evaluate the pharmacokinetics of ceftaroline in adult subjects with CABP at risk for infection due to MRSA
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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 subject or legally acceptable representative was obtained before initiating study-related assessments or procedures.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Georgia: 18
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Country: Number of subjects enrolled |
Poland: 8
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Country: Number of subjects enrolled |
Romania: 1
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Country: Number of subjects enrolled |
Russian Federation: 2
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Country: Number of subjects enrolled |
Ukraine: 12
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Country: Number of subjects enrolled |
United States: 8
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Worldwide total number of subjects |
49
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EEA total number of subjects |
9
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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) |
0
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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) |
29
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From 65 to 84 years |
18
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85 years and over |
2
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 49 subjects (male and female) ≥ 18 years of age with Community-acquired Bacterial Pneumonia (CABP) that warranted 3 days of initial hospitalization, a minimum of 3 days of IV antibacterial therapy, and a minimum of 5 days but no more than 14 days total of study therapy (IV and oral combined) 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 |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ceftaroline fosamil | ||||||||||||||||||||||||
Arm description |
32 subjects aged ≥ 18 years were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||||||||||||||||||||||||
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 every 8 hours (q8h) as follows:
- First daily dose: two 300-mg doses infused consecutively, each over 30 (± 5) minutes
- Second and third daily doses: 600 mg infused over 60 (± 10) minutes
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Investigational medicinal product name |
Azithromycin
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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, Tablet
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Routes of administration |
Intravenous use, Oral use
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Dosage and administration details |
Azithromycin (open-label adjunctive macrolide) was given q24h as a single 500-mg dose on Study Day 1, followed by 250 mg daily up to Study Day 5 (3 days minimum); azithromycin dosed oral then IV (over 60 [± 10] min), or IV then oral.
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Arm title
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Comparator | ||||||||||||||||||||||||
Arm description |
17 subjects aged ≥ 18 years were randomized to receive comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||||||||||||||||||||||||
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 was infused every 12 hours (q12h) at an initial dose of 15 mg/kg; subsequent dosing should be infused at 10 mg/min to maintain serum trough concentrations of 15 – 20 mg/L. Vancomycin was only to be discontinued if a non-MRSA respiratory pathogen was identified.
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Investigational medicinal product name |
Cetriaxone
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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 ceftriaxone 2 g was infused over 30 (± 5) minutes q24h immediately followed by IV saline placebo infused over 30 (± 5) minutes.
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Investigational medicinal product name |
Azithromycin
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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, Tablet
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Routes of administration |
Intravenous use, Oral use
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Dosage and administration details |
Azithromycin (open-label adjunctive macrolide) was given q24h as a single 500-mg dose on Study Day 1, followed by 250 mg daily up to Study Day 5 (3 days minimum); azithromycin dosed oral then IV (over 60 [± 10] min), or IV then oral.
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Baseline characteristics reporting groups
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Reporting group title |
Ceftaroline fosamil
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Reporting group description |
32 subjects aged ≥ 18 years were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Comparator
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Reporting group description |
17 subjects aged ≥ 18 years were randomized to receive comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ceftaroline fosamil
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Reporting group description |
32 subjects aged ≥ 18 years were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||
Reporting group title |
Comparator
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Reporting group description |
17 subjects aged ≥ 18 years were randomized to receive comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||
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 randomised subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen).
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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 randomized subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen).
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Subject analysis set title |
Ceftaroline - mMITT Set
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
The microbiological Modified Intent-to-Treat (mMITT Population) consists of all subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline.
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Subject analysis set title |
Comparator - mMITT Set
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
The microbiological Modified Intent-to-Treat (mMITT) Population consists of all subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline.
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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 randomized subjects who received any amount of IV study drug, and will be analysed according to the treatment actually received.
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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 randomized subjects who received any amount of IV study drug, and will be analysed according to the treatment actually received.
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End point title |
Symptom Improvement at Study Day 4 - MITT Set [1] | ||||||||||||||||||
End point description |
A response for symptom improvement at Study Day 4 is defined as improvement in at least 2 and no worsening of any of the following symptoms: cough, dyspnoea, sputum production, and chest pain.
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End point type |
Primary
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End point timeframe |
Symptom Improvement at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
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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 study 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 Stability at Study Day 4 - MITT Set [2] | ||||||||||||||||||
End point description |
A response for clinical stability at Study Day 4 is defined as meeting all of the following criteria:
(1) Temperature ≤ 37.8°C), (2) Heart rate ≤ 100 beats/min, (3) Respiratory rate ≤ 24 breaths/min, (4) Systolic blood pressure ≥ 90 mm Hg, and (5) Oxygen saturation ≥ 90%.
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End point type |
Primary
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End point timeframe |
Clinical Stability at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
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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 study 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 Success at Study day 4 - MITT Set [3] | ||||||||||||||||||
End point description |
A response for clinical success is defined as a subject with a response for both symptom improvement and clinical stability.
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End point type |
Primary
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End point timeframe |
Clinical Success at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
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Notes [3] - 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 study 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 |
Symptom Improvement at Study Day 4 - mMITT Set [4] | ||||||||||||||||||
End point description |
A response for symptom improvement at Study Day 4 is defined as improvement in at least 2 and no worsening of any of the following symptoms: cough, dyspnoea, sputum production, and chest pain.
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End point type |
Primary
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End point timeframe |
Symptom Improvement at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
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Notes [4] - 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 study 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 Stability at Study Day 4 - mMITT Set [5] | ||||||||||||||||||
End point description |
A response for clinical stability at Study Day 4 is defined as meeting all of the following criteria:
(1) Temperature ≤ 37.8°C), (2) Heart rate ≤ 100 beats/min, (3) Respiratory rate ≤ 24 breaths/min, (4) Systolic blood pressure ≥ 90 mm Hg, and (5) Oxygen saturation ≥ 90%.
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End point type |
Primary
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End point timeframe |
Clinical Stability at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
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Notes [5] - 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 study 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 Success at Study Day 4 - mMITT Set [6] | ||||||||||||||||||
End point description |
A response for clinical success is defined as a subject with a response for both symptom improvement and clinical stability.
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End point type |
Primary
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End point timeframe |
Clinical Success at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
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Notes [6] - 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 study 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 Outcome at TOC - MITT Set [7] | ||||||||||||||||||
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 |
Primary
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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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Notes [7] - 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 study 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 Outcome at TOC - mMITT Set [8] | ||||||||||||||||||
End point description |
Clinical Outcome at TOC is defined as assessment of clinical cure, clinical failure and indeterminate for the mMITT population at Test-Of-Cure.
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End point type |
Primary
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End point timeframe |
Clinical Outcome at Test-of-Cure (TOC) was evaluated 8 to 15 days after the last dose of any study drug [IV or PO].
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Notes [8] - 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 study is not powered for inferential statistical analysis. |
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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 |
From signing of the ICF to 21 to 35 days after last dose of any study drug [IV or PO]).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Ceftaroline fosamil
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Reporting group description |
32 subjects aged ≥ 18 years of age were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Comparator
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Reporting group description |
17 subjects ≥ 18 years of age were randomized to comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? No | |||||||
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 |