TonsillitisPhase 3PRI-angineNCT00393744
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
A Phase 3 study testing pristinamycin and amoxicillin in people with Tonsillitis, run by Sanofi at 1 site in France.
Trial summary
The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between… Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Tonsillitis
- What is being tested?
- pristinamycin and amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Mar 2008
- 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 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- subjects of both sexes
- aged between 6 and 25 years,
- weight : ≥ 20kg
- with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable satellite adenopathy)
- confirmation by positive RDT
- provision of throat swabs for culture
- ability to swallow tablets
Who cannot join
- Related to the study disease:
- suspected viral infection (concomitant dysphonia, cough, conjunctivitis, rhinitis)
- adenophlegmon, peritonsillar abscesses.
- Related to the study treatment:
- known or suspected allergy to beta-lactamines (penicillin, cephalosporin)
- suspected infectious mononucleosis (increased risk of skin disorders)
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- phenylketonuria (due to the presence of aspartame)
- congenital galactosaemia, glucose/galactose malabsorption syndrome, lactase deficiency (due to the presence of lactose, in powder or suspension form)
- allergy to pristinamycin and/or virginiamycin
- history of pustular rash with pristinamycin
- hypersensitivity or gluten intolerant (due to the presence of wheat starch)
- ongoing treatment with cyclosporine, methotrexate, colchicine, allopurinol, tacrolimus or oral anticoagulants.
- Related to previous treatment:
- subjects receiving antibiotic therapy in the month prior to inclusion, except for azithromycin, for which the exclusion period is 3 months.
- subjects on short-term corticosteroids. Subjects on long-term corticosteroids initiated before the start of the study and taken at a controlled dosage may be included.
- Related to subjects:
- breast-feeding women
- women either pregnant or attempting to conceive
- subjects likely, during the course of the study to receive treatments prohibited by the protocol
- treatment with other investigational drugs in the 4 weeks prior to inclusion in the study
- immunodepression, clinically significant endocrine disease, cardiovascular disease, neurological disease, or any other marked diseases resulting in complications in performance of the study or interpretation of the study data
- known hepatic impairment
- known renal impairment (creatinine clearance < 30 ml/minute)
- cancer, blood dyscrasias
- previous history of drug or alcohol abuse.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years.
The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.
- Conditions
- Tonsillitis
- Being tested
- pristinamycin, amoxicillin
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pristinamycinDrug
50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
amoxicillinDrug
50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: pristinamycin |
| 2 | Active comparator | Not described Receives: Drug: amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial eradication
Measured: at V3
Secondary outcomes (1)
adverse events
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2008
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
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie SEBILLE, Dr, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393744
- Sponsor's protocol ID
- PRIST_L_01683
- Other IDs
- EudraCT #: 2006-002127-16
- Acronym
- PRI-angine
- Status last verified
- Mar 2009
- First submitted
- 27 Oct 2006
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years.
- ClinicalTrials.gov ID
- NCT00393744
- Acronym / sponsor ID
- PRI-angine / PRIST_L_01683
- Conditions
- Tonsillitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Mar 2008 (actual)
- First posted
- 30 Oct 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.
The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pristinamycin |
| 2 | Active comparator | Drug: amoxicillin |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- subjects of both sexes
- aged between 6 and 25 years,
- weight : ≥ 20kg
- with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable satellite adenopathy)
- confirmation by positive RDT
Key exclusion criteria (26 listed)
- Related to the study disease:
- Related to the study treatment:
- Related to previous treatment:
- Related to subjects:
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| pristinamycin50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days | Drug | 1 |
| amoxicillin50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days | Drug | 2 |
Primary outcome
bacterial eradication
Time frame: at V3
1 secondary outcome
adverse events
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.
Marie SEBILLE, Dr study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pristinamycin and amoxicillin in people with Tonsillitis, run by Sanofi at 1 site in France.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bacterial eradication (time frame: at V3). 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 17 Mar 2009.