Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Clarithromycin 500 mg ER: In this PMS patients
seeking treatment for URTI will
continue receiving clarithromycin 500 mg ER tablets once daily for seven days
Control Intervention1: NIL:
Sponsors
Abbott Healthcare Private Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott Healthcare Private Limited
Outcome results
None listed