Evaluation of Effectiveness And Safety Of Clarithromycin In Upper Respiratory Tract Infectio

Phase 4

Conditions: Health Condition 1: J069- Acute upper respiratory infection,unspecified

Registration Number: CTRI/2024/06/069427

Lead Sponsor: Abbott Healthcare Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Male and female patients 18 to 65 years of age

2 Newly diagnosed patients with onset of symptoms in previous 7 days with acute URTI (acute bacterial sinusitis, acute pharyngotonsillitis or acute otitis media) in the designated clinics as part of routine clinical care

3 Patients prescribed to start clarithromycin 500 mg ER tablets once daily, as part of routine clinical practice

4 Patients willing and able to sign a patient authorisation form (PAF) prior to study participation

Exclusion Criteria

• Patients who had been diagnosed and treated for an acute infection within the previous 28 days of study enrolment.

• Patients who may require hospitalization or ventilator support for the present complaints.

• Patients with history of clarithromycin or other antibiotic use in the preceding 1 month of study enrolment.

• Patients diagnosed with LRTI as per Investigator discretion.

• Hypersensitivity to macrolides.

• Patients on concomitant medication like steroids or other antibiotics.

• Patients on any other contraindicated medication based on approved prescribing information.

• Patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including anti.

• Pregnant or lactating women.

• Patients with any other conditions or diseases that Investigator/ HCP considers as ineligible to enroll in the study based on approved prescribing information.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effectiveness of clarithromycin 500 mg ER in adult patients with acute bacterial upper respiratory tract infections (otitis media, sinusitis and pharyngotonsillitis) by evaluating percentage of patients termed cured/ improved/ failure.Timepoint: Day 7

Secondary Outcome Measures

Name	Time	Method
To assess the effectiveness of clarithromycin 500 mg ER in adult patients with acute bacterial upper respiratory tract infections (otitis media, sinusitis and pharyngotonsillitis) by evaluating the percentage change in clinical symptoms scores.Timepoint: Day 7