Clinical Trial Results:
Multinational, Randomized, Double Blind, Comparative Study to Evaluate The Efficacy and Safety of Telithromycin, 800 mg Once Daily for 5 Days, Versus Penicillin V, 500 mg Three Times Daily for 10 Days, In Adolescent and Adult Subjects Equal to or Over 13 Years of Age With Streptococcus Pyogenes Tonsillitis/Pharyngitis
Summary
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EudraCT number |
2014-004631-39 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
20 Sep 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
23 May 2016
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First version publication date |
28 Jun 2015
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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 |
EFC6134, HMR3647B/3006
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00315549 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sanofi U.S Services Inc.
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Sponsor organisation address |
55 Corporate Drive Bridgewater, New Jersey, United States, 08807
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Public contact |
Trial Transparency Team, Sanofi aventis recherche & développement
, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi aventis recherche & développement
, Contact-US@sanofi.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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Jun 2008
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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 |
20 Sep 2007
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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 |
Primary objective of this study was to compare the bacteriologic efficacy of 5 days of telithromycin to 10 days of penicillin V in subjects with baseline bacterial throat culture positive for Streptococcus pyogenes (S. pyogenes) and repeat throat culture performed at the posttherapy/test-of-cure visit (Visit 3, Days 13 to 17) in the per-protocol population for analysis of bacteriologic outcome (PPb).
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Protection of trial subjects |
Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency.
Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Feb 2006
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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: 233
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Worldwide total number of subjects |
233
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EEA total number of subjects |
0
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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) |
79
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Adults (18-64 years) |
153
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 41 sites in United States of America. A total of 256 subjects were screened between 20 February 2006 and 7 June 2006. | |||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Of 256 screened subjects, 233 subjects were randomized. | |||||||||||||||||||||||||||||||||
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 |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Telithromycin | |||||||||||||||||||||||||||||||||
Arm description |
Telithromycin for 5 days and placebo for 10 days. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Telithromycin
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Investigational medicinal product code |
HMR3647
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Telithromycin tablet over-encapsulated 800 mg once daily.
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Investigational medicinal product name |
Placebo (for Penicillin V)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo matched to Penicillin V 3 times daily for 10 days.
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Arm title
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Penicillin V | |||||||||||||||||||||||||||||||||
Arm description |
Penicillin V for 10 days and placebo for 5 days. | |||||||||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Penicllin V potassium
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Penicllin V tablet over-encapsulated 500 mg three times daily.
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Investigational medicinal product name |
Placebo (for Telithromycin)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo matched to Telithromycin once daily for 5 days.
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Baseline characteristics reporting groups
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Reporting group title |
Telithromycin
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Reporting group description |
Telithromycin for 5 days and placebo for 10 days. | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Penicillin V
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Reporting group description |
Penicillin V for 10 days and placebo for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Telithromycin
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Reporting group description |
Telithromycin for 5 days and placebo for 10 days. | ||
Reporting group title |
Penicillin V
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Reporting group description |
Penicillin V for 10 days and placebo for 5 days. |
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End point title |
Percentage of Subjects According to Bacteriological Outcome in Bacteriological Per Protocol (PPb) Population [1] | ||||||||||||||||||
End point description |
Bacteriologic cure was defined as eradication of S. pyogenes at postbaseline culture (documented eradication). Bacteriologic failure was defined to occur if after 72 hours of study medication, a subject had a positive repeat postbaseline throat culture for S. pyogenes. The PPb population was defined as the per protocol population for analysis of bacteriologic outcome. The PPb population contained all subjects of the clinical per protocol population (PPc) population with isolation of S. pyogenes at Visit 1 and a postbaseline culture at the Visit 3 and/or Visit 4 time window excluding the major protocol violations. Bacteriologic outcome assessment was made for the visit window in which the culture was obtained.
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End point type |
Primary
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End point timeframe |
At post therapy (Day 13-17)
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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 was terminated early (randomization of 233 subjects/760 planned) the type II error was not controlled as planned and only descriptive statistics were generated. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects According to Bacteriological Outcome in Bacteriological Modified Intent to Treat (mITTb) Population | |||||||||||||||||||||
End point description |
Analysis was carried out on bmITT population defined as the bacteriological modified intent to treat population that included all subjects that were in the mITT population with isolation of S. pyogenes at Visit 1.
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End point type |
Secondary
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End point timeframe |
At post therapy (Day 13-17)
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects According to Bacteriological Outcome in PPb Population (At Late Post Therapy) | ||||||||||||||||||
End point description |
Bacteriologic cure was defined as eradication of S. pyogenes at postbaseline culture (documented eradication). Bacteriologic failure was defined to occur if after 72 hours of study medication, a subject had a positive repeat Postbaseline throat culture for S. pyogenes.. Analysis was performed on PPb population. Number of subjects analysed = subjects with data available at Day 38-45.
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End point type |
Secondary
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End point timeframe |
At late post therapy (Day 38-45)
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Adverse Events of Special Interest | ||||||||||||||||||
End point description |
Analysis was carried out on safety population which included all randomized and treated subjects.
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End point type |
Secondary
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End point timeframe |
7 days after end of treatment
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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 |
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Days 38-45) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
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Adverse event reporting additional description |
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (first dose of study medication and up to 7 days after the last dose of study medication or, up to 17 days after the first dose of study medication, whichever is later).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.1
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Reporting groups
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Reporting group title |
Penicillin
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Reporting group description |
Penicillin V for 10 days and placebo for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Telithromycin
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Reporting group description |
Telithromycin for 5 days and placebo for 10 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |