TonsillitisPhase 3NCT00643149
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
A Phase 3 study testing amoxicillin and azithromycin SR in people with Tonsillitis, run by Pfizer at 46 sites in 5 countries.
Trial summary
The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Tonsillitis
- What is being tested?
- amoxicillin and azithromycin SR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 693 participants
- Where
- 46 sitesin 5 countries
- Study dates
- May 2003to Mar 2004
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.
Who cannot join
- Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.
Trial locations and contacts
46 sites in 5 countries.
46 sites in 5 countries
United States33 sites
Pfizer Investigational Site
Bardstown, Kentucky, 40004
Pfizer Investigational Site
Beachwood, Ohio, 44122
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Chesterland, Ohio, 44026
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Cleveland, Ohio, 44111
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Evansville, Indiana, 47710
Pfizer Investigational Site
Evansville, Indiana, 47713
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Hoover, Alabama, 35244
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
McMurray, Pennsylvania, 15317
Pfizer Investigational Site
Newburgh, Indiana, 47360
Pfizer Investigational Site
Newburgh, Indiana, 47630
Pfizer Investigational Site
Pelham, Alabama, 35124
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15234
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15241
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Salt Lake City, Utah, 84103
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84111
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Springfield, Kentucky, 40069
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Wichita, Kansas, 67212
Pfizer Investigational Site
Willoughby, Ohio, 44094
Pfizer Investigational Site
Youngstown, Ohio, 44501
Canada4 sites
Pfizer Investigational Site
Calgary, Alberta, T2T 5C7
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 7H9
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1M3
Costa Rica4 sites
Pfizer Investigational Site
Escazú, Provincia de San José
Pfizer Investigational Site
San José, Provincia de San José
Pfizer Investigational Site
San José
Pfizer Investigational Site
Uruca, Provincia de San José
India4 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Hyderabad, Andhara Pradesh, 500 033
Pfizer Investigational Site
Kochi, Kerala, 682 026
Pfizer Investigational Site
Mumbai, Maharashtra, 400 0124
Guatemala1 site
Pfizer Investigational Site
Guatemala City, Departamento de Guatemala
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A Β-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children
The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.
- Conditions
- Tonsillitis
- Being tested
- amoxicillin, azithromycin SR
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillinDrug
10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
azithromycin SRDrug
60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: amoxicillin |
| 2 | Experimental | Not described Receives: Drug: azithromycin SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population
Measured: TOC visit (Day 24-28)
Secondary outcomes (8)
Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit
Measured: LTFU Visit (Day 38-45)
Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population
Measured: TOC Visit (Day 24-28)
Clinical response (cure or relapse) at the LTFU visit
Measured: LTFU Visit (Day 38-45)
Pathogen susceptibility versus bacteriologic response
Measured: Not reported
Adverse events (AEs) were assessed for all treated subjects
Measured: Continuous
Vital signs and physical examinations were recorded
Measured: Baseline and as necessary
Clinical laboratory testing (hematology and blood chemistry)
Measured: As necessary
Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMay 2003
- Study completionMar 2004
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 PfizerThe 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
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643149
- Sponsor's protocol ID
- A0661071
- Status last verified
- May 2011
- First submitted
- 19 Mar 2008
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A Β-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children
- ClinicalTrials.gov ID
- NCT00643149
- Acronym / sponsor ID
- A0661071
- Conditions
- Tonsillitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 26 Mar 2008 (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 objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: amoxicillin |
| 2 | Experimental | Drug: azithromycin SR |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.
Key exclusion criteria (1 listed)
- Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.
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 |
|---|---|---|
| amoxicillin10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours | Drug | 1 |
| azithromycin SR60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat | Drug | 2 |
Primary outcome
Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population
Time frame: TOC visit (Day 24-28)
8 secondary outcomes
Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit
Time frame: LTFU Visit (Day 38-45)
Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population
Time frame: TOC Visit (Day 24-28)
Clinical response (cure or relapse) at the LTFU visit
Time frame: LTFU Visit (Day 38-45)
Pathogen susceptibility versus bacteriologic response
Time frame: Not reported
Adverse events (AEs) were assessed for all treated subjects
Time frame: Continuous
Vital signs and physical examinations were recorded
Time frame: Baseline and as necessary
Clinical laboratory testing (hematology and blood chemistry)
Time frame: As necessary
Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose
Time frame: Day 1
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 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
46 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amoxicillin and azithromycin SR in people with Tonsillitis, run by Pfizer at 46 sites in 5 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 1 inclusion and 1 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 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Canada, Costa Rica, India, Guatemala. 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?
Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population (time frame: TOC visit (Day 24-28)). 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 May 2011.