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Completed

NCT Number: 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

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.

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Key information

Conditions

Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tonsillitis

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Erembodegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

azithromycin (Zithromax)

Drug

azithromycin 500 mg tablet by mouth once daily for 3 days

Placebo

Drug

placebo

Azithromycin SR

Drug

azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose

Primary outcomes

  1. bacteriologic response in the Bacteriologic per Protocol population

    Time frame: Test of Cure (TOC) visit (Days 24-28)

Secondary outcomes

  1. sponsor assessment of clinical response in the Bacteriologic per Protocol population

    Time frame: TOC visit

  2. bacteriologic response for the remaining study populations

    Time frame: TOC visit

  3. sponsor assessment of clinical response for the Bacteriologic per Protocol population

    Time frame: Long-Term Follow-Up (LTFU) visit (Days 38-45)

  4. bacteriologic response for the Bacteriologic per Protocol population

    Time frame: TOC visit

  5. summary of baseline susceptibilities

    Time frame: Study endpoint

  6. adverse events

    Time frame: Continuous

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 26, 2008
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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