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NCT00644293 Clinical Trial

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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00644293
Other study ID # A0661119
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated June 3, 2011
Start date January 2003
Est. completion date April 2004

Study information
Verified date June 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 598
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• azithromycin (Zithromax)
azithromycin 500 mg tablet by mouth once daily for 3 days
• placebo
placebo
• azithromycin SR
azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
• placebo
placebo

Locations
Country Name City State
Belgium Pfizer Investigational Site Erembodegem
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Hasselt
Finland Pfizer Investigational Site Nokia
Finland Pfizer Investigational Site Tampere
France Pfizer Investigational Site Courbevoie
France Pfizer Investigational Site Gentilly
France Pfizer Investigational Site Lille
France Pfizer Investigational Site Montpellier
France Pfizer Investigational Site Rouen
France Pfizer Investigational Site Villejuif
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Erkner
Germany Pfizer Investigational Site Ludwigshafen
Germany Pfizer Investigational Site Ruedersdorf
Germany Pfizer Investigational Site Tostedt
Germany Pfizer Investigational Site Villingen-Schwenningen
Germany Pfizer Investigational Site Wuerzburg
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Hyderabad
India Pfizer Investigational Site Kochi Kerala
India Pfizer Investigational Site Pune
Italy Pfizer Investigational Site Foligno PG
Italy Pfizer Investigational Site Gualdo Tadino PG
Italy Pfizer Investigational Site S.Eraclio-Foligno PG
Italy Pfizer Investigational Site Spoleto PG
Italy Pfizer Investigational Site Vocabolo Gaifana-Gualdo Tadino PG
Netherlands Pfizer Investigational Site Ede (Gld)
Netherlands Pfizer Investigational Site Geldermalsen
Netherlands Pfizer Investigational Site Huizen
Norway Pfizer Investigational Site Elverum
Norway Pfizer Investigational Site Skedsmokorset
United Kingdom Pfizer Investigational Site Atherstone Warwickshire
United Kingdom Pfizer Investigational Site Bath Avon
United Kingdom Pfizer Investigational Site Coventry
United Kingdom Pfizer Investigational Site Glenrothes Fife
United Kingdom Pfizer Investigational Site Hastings East Sussex
United Kingdom Pfizer Investigational Site High Valleyfield Fife
United Kingdom Pfizer Investigational Site Kent
United Kingdom Pfizer Investigational Site Kent
United Kingdom Pfizer Investigational Site Kent
United Kingdom Pfizer Investigational Site Tunbrige Wells Kent
United States Pfizer Investigational Site Bensalem Pennsylvania
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Harleysville Pennsylvania
United States Pfizer Investigational Site Hickory North Carolina
United States Pfizer Investigational Site Meridian Idaho
United States Pfizer Investigational Site Nampa Idaho
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site West Jordan Utah

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Finland,  France,  Germany,  India,  Italy,  Netherlands,  Norway,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary bacteriologic response in the Bacteriologic per Protocol population Test of Cure (TOC) visit (Days 24-28) No
Secondary sponsor assessment of clinical response in the Bacteriologic per Protocol population TOC visit No
Secondary bacteriologic response for the remaining study populations TOC visit No
Secondary sponsor assessment of clinical response for the Bacteriologic per Protocol population Long-Term Follow-Up (LTFU) visit (Days 38-45) No
Secondary bacteriologic response for the Bacteriologic per Protocol population TOC visit No
Secondary summary of baseline susceptibilities Study endpoint No
Secondary adverse events Continuous Yes
See also
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Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02712307 - Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci Phase 4
Enrolling by invitation NCT02205580 - Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children Phase 4
Completed NCT01721486 - Acetaminophen's Efficacy For Post-operative Pain Phase 4
Active, not recruiting NCT01691690 - Analgesic Effect of IV Acetaminophen in Tonsillectomies Phase 2
Completed NCT00393744 - Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children Phase 3
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Active, not recruiting NCT00136877 - Tonsillectomy in Recurrent Tonsillitis N/A
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Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Recruiting NCT03137823 - Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface N/A
Completed NCT02571075 - Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea N/A
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3
Completed NCT01465009 - Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold Phase 4
Recruiting NCT04164511 - Does Ice Cream Help With Post-tonsillectomy Pain
Completed NCT04653376 - Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases

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