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Comparison of effectiveness of Ciprofloxacin and Cefpodoxime in patients with acute attack of chronic middle ear infectio

Phase 4
Completed
Conditions
Health Condition 1: H661- Chronic tubotympanic suppurative otitis mediaHealth Condition 2: null- Mild to moderate cases of acute exacerbation of chronic suppurative otitis media
Registration Number
CTRI/2011/10/002079
Lead Sponsor
Arijit Ghosh
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
42
Inclusion Criteria

1.Adults of either sex

2.Aged between 18 and 60

3.Clinically documented cases of tubo-tympanic type chronic suppurative otitis media defined as long standing chronic suppuration of middle ear cleft and its muco-periosteal lining resulting in discharging ear and deafness presenting with clinical symptoms and signs of acute exacerbation of the disease

4.Baseline otological symptom score of more than 4 but less than 8

Exclusion Criteria

1.Female patients who are pregnant or lactating 2.Severe cases of AECSOM for which hospitalization or parenteral antibiotic treatment is required and

3. Patients with otological symptom score of less than4 and more than 8 will be also excluded from the study.

4.Patients with foul smelling discharge and those who received antibiotic in preceding 4 weeks of screening will be left out.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical cure <br/ ><br> <br/ ><br>Subject will be categorized as clinical cure if otological symptom score is less than 3 at the day 14 visit.Timepoint: day 14 visit
Secondary Outcome Measures
NameTimeMethod
Clinical improvement <br/ ><br> <br/ ><br>Subject will be categorized as clinical improvement if there is at least one scale one scale reduction from baseline score between 3 to 5 at the day 14 visit assessment.Timepoint: day 14 visit
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