PharyngitisPhase 3NCT00644293
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
A Phase 3 study testing azithromycin (Zithromax) and azithromycin SR in people with Pharyngitis and Tonsillitis, run by Pfizer at 59 sites in 10 countries.
Trial summary
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pharyngitis, Tonsillitis
- What is being tested?
- azithromycin (Zithromax) and azithromycin SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 598 participants
- Where
- 59 sitesin 10 countries
- Study dates
- Jan 2003to Apr 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS
Who cannot join
- Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.
Trial locations and contacts
59 sites in 10 countries.
59 sites in 10 countries
United States16 sites
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Boise, Idaho, 83651
Pfizer Investigational Site
Boise, Idaho, 83703
Pfizer Investigational Site
Boise, Idaho, 83704
Pfizer Investigational Site
Boise, Idaho, 83706
Pfizer Investigational Site
Boise, Idaho, 83709
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Eugene, Oregon, 97404
Pfizer Investigational Site
Harleysville, Pennsylvania, 19438
Pfizer Investigational Site
Hickory, North Carolina, 28601
Pfizer Investigational Site
Meridian, Idaho, 83642
Pfizer Investigational Site
Nampa, Idaho, 83651
Pfizer Investigational Site
Omaha, Nebraska, 68144
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
West Jordan, Utah, 84088
United Kingdom10 sites
Pfizer Investigational Site
Atherstone, Warwickshire, CV9 1EU
Pfizer Investigational Site
Bath, Avon, BA2 3HT
Pfizer Investigational Site
Coventry, CV7 8LA
Pfizer Investigational Site
Glenrothes, Fife, KY6 3LQ
Pfizer Investigational Site
Hastings, East Sussex, TN34 3EY
Pfizer Investigational Site
High Valleyfield, Fife, KY12 8SJ
Pfizer Investigational Site
Kent, TN1 2DX
Pfizer Investigational Site
Kent, TN10 3ET
Pfizer Investigational Site
Kent, TN11 9HL
Pfizer Investigational Site
Tunbrige Wells, Kent, TN1 2EP
Germany8 sites
Pfizer Investigational Site
Berlin, 10965
Pfizer Investigational Site
Berlin, 13593
Pfizer Investigational Site
Erkner, 15537
Pfizer Investigational Site
Ludwigshafen, 67069
Pfizer Investigational Site
Rüdersdorf, 15562
Pfizer Investigational Site
Tostedt, D-21255
Pfizer Investigational Site
Villingen-Schwenningen, 78054
Pfizer Investigational Site
Würzburg, 97070
France6 sites
Pfizer Investigational Site
Courbevoie, 92 400
Pfizer Investigational Site
Gentilly, 94 250
Pfizer Investigational Site
Lille, 59000
Pfizer Investigational Site
Montpellier, 34 000
Pfizer Investigational Site
Rouen, 76 100
Pfizer Investigational Site
Villejuif, 94 800
Italy5 sites
Pfizer Investigational Site
Foligno, PG, 06034
Pfizer Investigational Site
Gualdo Tadino, PG, 06023
Pfizer Investigational Site
S.Eraclio-Foligno, PG, 06087
Pfizer Investigational Site
Spoleto, PG, 06049
Pfizer Investigational Site
Vocabolo Gaifana-Gualdo Tadino, PG, 06020
India4 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 0344
Pfizer Investigational Site
Hyderabad, 500 033
Pfizer Investigational Site
Kochi, Kerala, 682 026
Pfizer Investigational Site
Pune, 411 004
Belgium3 sites
Pfizer Investigational Site
Erembodegem, 9320
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Hasselt, 3500
Netherlands3 sites
Pfizer Investigational Site
Ede (Gld), 6711 PS
Pfizer Investigational Site
Geldermalsen, 4191 AH
Pfizer Investigational Site
Huizen, 1271 BB
Finland2 sites
Pfizer Investigational Site
Nokia, 37100
Pfizer Investigational Site
Tampere, 33200
Norway2 sites
Pfizer Investigational Site
Elverum, 2402
Pfizer Investigational Site
Skedsmokorset, 2020
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.
- Conditions
- Pharyngitis, Tonsillitis
- Being tested
- azithromycin (Zithromax), placebo, azithromycin SR
- Medical subject headings
- Pharyngitis, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin (Zithromax)Drug
azithromycin 500 mg tablet by mouth once daily for 3 days
placeboDrug
placebo
azithromycin SRDrug
azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: azithromycin (Zithromax); Drug: placebo |
| 2 | Experimental | Not described Receives: Drug: azithromycin SR; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacteriologic response in the Bacteriologic per Protocol population
Measured: Test of Cure (TOC) visit (Days 24-28)
Secondary outcomes (6)
sponsor assessment of clinical response in the Bacteriologic per Protocol population
Measured: TOC visit
bacteriologic response for the remaining study populations
Measured: TOC visit
sponsor assessment of clinical response for the Bacteriologic per Protocol population
Measured: Long-Term Follow-Up (LTFU) visit (Days 38-45)
bacteriologic response for the Bacteriologic per Protocol population
Measured: TOC visit
summary of baseline susceptibilities
Measured: Study endpoint
adverse events
Measured: Continuous
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 startJan 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies 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
- 598 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
- NCT00644293
- Sponsor's protocol ID
- A0661119
- Status last verified
- Jun 2011
- First submitted
- 19 Mar 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 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 Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT00644293
- Acronym / sponsor ID
- A0661119
- Conditions
- Pharyngitis, Tonsillitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Apr 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.
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.
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: azithromycin (Zithromax), Drug: placebo |
| 2 | Experimental | Drug: azithromycin SR, Drug: placebo |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS
Key exclusion criteria (1 listed)
- Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.
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 |
|---|---|---|
| azithromycin (Zithromax)azithromycin 500 mg tablet by mouth once daily for 3 days | Drug | 1 |
| placeboplacebo | Drug | 1 |
| azithromycin SRazithromycin SR 2.0 g by mouth as an oral slurry for 1 dose | Drug | 2 |
| placeboplacebo | Drug | 2 |
Primary outcome
bacteriologic response in the Bacteriologic per Protocol population
Time frame: Test of Cure (TOC) visit (Days 24-28)
6 secondary outcomes
sponsor assessment of clinical response in the Bacteriologic per Protocol population
Time frame: TOC visit
bacteriologic response for the remaining study populations
Time frame: TOC visit
sponsor assessment of clinical response for the Bacteriologic per Protocol population
Time frame: Long-Term Follow-Up (LTFU) visit (Days 38-45)
bacteriologic response for the Bacteriologic per Protocol population
Time frame: TOC visit
summary of baseline susceptibilities
Time frame: Study endpoint
adverse events
Time frame: Continuous
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 8 Jun 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
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Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) Pharyngitis
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
59 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azithromycin (Zithromax) and azithromycin SR in people with Pharyngitis and Tonsillitis, run by Pfizer at 59 sites in 10 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, United Kingdom, Germany, France, Italy and 5 more countries. 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 in the Bacteriologic per Protocol population (time frame: Test of Cure (TOC) visit (Days 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 8 Jun 2011; AzTrials last refreshed its copy on 27 Oct 2026.