TonsillitisPhase 3NCT00315549
TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
A Phase 3 study testing Telithromycin and Penicillin in people with Tonsillitis and Pharyngitis, run by Sanofi at 4 sites in 4 countries.
Trial summary
This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Tonsillitis, Pharyngitis
- What is being tested?
- Telithromycin and Penicillin
- How many people
- 233 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2006to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age equal to or over 13 years;
- For female subjects, the following conditions are to be met:
- Subject is premenarchal or surgically incapable of bearing children,
- Subject is of childbearing potential and all of the following conditions are met:
- Have normal menstrual flow within 1 month before study entry,
- Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and
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- Must agree to use an accepted method of contraception throughout the study (if sexually active);
- Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:
- A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and
- A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:
- Tonsil and/or pharyngeal erythema and/or exudate;
- Cervical adenopathy;
- Uvular edema;
- Fever
Who cannot join
- Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough);
- History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P;
- Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis);
- History of rheumatic heart disease;
- Known congenital prolonged QT syndrome;
- Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm);
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- Known impaired renal function, as shown by creatinine clearance ≤25 mL/min
- Myasthenia gravis;
- History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins;
- Previous enrollment in this study or previous treatment with telithromycin;
- Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.
- Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;
- Has been treated with any investigational medication within the last 30 days;
- Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Multinational, Randomized, Double Blind, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 800 mg od Versus 10 Days Penicillin V 500 mg Tid in Adolescent and Adult Subjects Equal to or Over 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis
This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.
- Conditions
- Tonsillitis, Pharyngitis
- Being tested
- Telithromycin, Penicillin
- Keywords
- Tonsillitis, pharyngitis, penicillin, telithromycin, ketolides, clinical trials
- Medical subject headings
- Tonsillitis, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelithromycinDrug
PenicillinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V insubjects at the posttherapy/test-of-cure (TOC) visit in the per protocol population.
Secondary outcomes (1)
To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V insubjects at the posttherapy/test-of-cure (TOC) visit andlate posttherapy visit (Visit 4) in the bacteriologic modified intent to treat population.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: Pediatric development program terminated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315549
- Sponsor's protocol ID
- EFC6134
- Other IDs
- HMR3647B/3006
- Status last verified
- Apr 2009
- First submitted
- 14 Apr 2006
- Last updated
- 3 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational, Randomized, Double Blind, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 800 mg od Versus 10 Days Penicillin V 500 mg Tid in Adolescent and Adult Subjects Equal to or Over 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis
- ClinicalTrials.gov ID
- NCT00315549
- Acronym / sponsor ID
- EFC6134
- Conditions
- Tonsillitis, Pharyngitis
- Keywords
- Tonsillitis, pharyngitis, penicillin, telithromycin, ketolides, clinical trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pediatric development program terminated by sponsor
- Enrolment
- 233 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Age equal to or over 13 years;
- For female subjects, the following conditions are to be met:
- Subject is premenarchal or surgically incapable of bearing children,
- Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:
Key exclusion criteria (14 listed)
- Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough);
- History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P;
- Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis);
- History of rheumatic heart disease;
- Known congenital prolonged QT syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telithromycin | Drug | – |
| Penicillin | Drug | – |
Primary outcome
To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V insubjects at the posttherapy/test-of-cure (TOC) visit in the per protocol population.
1 secondary outcome
To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V insubjects at the posttherapy/test-of-cure (TOC) visit andlate posttherapy visit (Visit 4) in the bacteriologic modified intent to treat population.
Results and safety
The study was stopped early (reason given: Pediatric development program terminated by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telithromycin and Penicillin in people with Tonsillitis and Pharyngitis, run by Sanofi at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Argentina, Chile, Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Pediatric development program terminated by sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the bacteriologic efficacy of 5-days of telithromycin to 10-days of penicillin V insubjects at the posttherapy/test-of-cure (TOC) visit in the per protocol population.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2009.