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
NCT00644293
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- 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
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | 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 ICMJE | A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A ?-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 598 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Finland, France, Germany, India, Italy, Netherlands, Norway, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00644293 | |||
Other Study ID Numbers ICMJE | A0661119 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |