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Clinical Trials/CTRI/2024/06/069427
CTRI/2024/06/069427
Recruiting
Phase 4

A Multicentre, Prospective Post-Marketing Observational Study To Evaluate The Effectiveness And Safety Of Clarithromycin 500 Mg ER In Upper Respiratory Tract Infection - NI

Abbott Healthcare Private Limited0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: J069- Acute upper respiratory infection,unspecified

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: J069- Acute upper respiratory infection,unspecified
Sponsor
Abbott Healthcare Private Limited
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Pms

Investigators

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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