Clinical trial NCT00644293: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Tonsillitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 598
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: bacteriologic response in the Bacteriologic per Protocol population
timeFrame: Test of Cure (TOC) visit (Days 24-28)
Secondary outcomes:
measure: sponsor assessment of clinical response in the Bacteriologic per Protocol population
timeFrame: TOC visit
measure: bacteriologic response for the remaining study populations
timeFrame: TOC visit
measure: sponsor assessment of clinical response for the Bacteriologic per Protocol population
timeFrame: Long-Term Follow-Up (LTFU) visit (Days 38-45)
measure: bacteriologic response for the Bacteriologic per Protocol population
timeFrame: TOC visit
measure: summary of baseline susceptibilities
timeFrame: Study endpoint
measure: adverse events
timeFrame: Continuous
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Meridian
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Nampa
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bensalem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Harleysville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Erembodegem
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Nokia
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Courbevoie
country: France
facility: Pfizer Investigational Site
city: Gentilly
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Erkner
country: Germany
facility: Pfizer Investigational Site
city: Ludwigshafen
country: Germany
facility: Pfizer Investigational Site
city: Ruedersdorf
country: Germany
facility: Pfizer Investigational Site
city: Tostedt
country: Germany
facility: Pfizer Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Hyderabad
country: India
facility: Pfizer Investigational Site
city: Pune
country: India
facility: Pfizer Investigational Site
city: Foligno
country: Italy
facility: Pfizer Investigational Site
state: PG
city: Gualdo Tadino
country: Italy
facility: Pfizer Investigational Site
state: PG
city: S.Eraclio-Foligno
country: Italy
facility: Pfizer Investigational Site
state: PG
city: Spoleto
country: Italy
facility: Pfizer Investigational Site
state: PG
city: Vocabolo Gaifana-Gualdo Tadino
country: Italy
facility: Pfizer Investigational Site
state: PG
city: Ede (Gld)
country: Netherlands
facility: Pfizer Investigational Site
city: Geldermalsen
country: Netherlands
facility: Pfizer Investigational Site
city: Huizen
country: Netherlands
facility: Pfizer Investigational Site
city: Elverum
country: Norway
facility: Pfizer Investigational Site
city: Skedsmokorset
country: Norway
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
state: Avon
city: Hastings
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Glenrothes
country: United Kingdom
facility: Pfizer Investigational Site
state: Fife
city: High Valleyfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Fife
city: Tunbrige Wells
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Atherstone
country: United Kingdom
facility: Pfizer Investigational Site
state: Warwickshire
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Kent
country: United Kingdom
facility: Pfizer Investigational Site
city: Kent
country: United Kingdom
facility: Pfizer Investigational Site
city: Kent
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: