A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

Pfizer99 enrolled

Overview

To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Upper Respiratory Tract Infection

Interventions

Azithromycin SRDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis Exclusion Criteria: * Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Locations (5)

Pfizer Investigational Site

Gobō, Wakayama, Japan

Pfizer Investigational Site

Hashimoto, Wakayama, Japan

Pfizer Investigational Site

Shinjo-cho, Tanabe, Wakayama, Japan

Pfizer Investigational Site

Wakayama, Wakayama, Japan

Outcomes

Primary Outcomes

The primary endpoint is Investigator's Clinical efficacy at Day 8.

Secondary Outcomes

Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data

Data from ClinicalTrials.gov

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