Skip to content

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

Comparison of efficacy and safety of Ciprofloxacin and Cefpodoxime in acute exacerbation of chronic suppurative otitis media: a randomized open labeled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/10/002079
Enrollment
42
Registered
2011-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H661- Chronic tubotympanic suppurative otitis media Health Condition 2: null- Mild to moderate cases of acute exacerbation of chronic suppurative otitis media

Interventions

Intervention1: cefpodoxime: Tab cefpodoxime (200 mg) 1 tab twice daily orally for 7 days Control Intervention1: Ciprofloxacin: Tab Ciprofloxacin (500 mg) 1 tab twice daily orally for 7 days

Sponsors

Arijit Ghosh
Lead Sponsor
Utpal Jana
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Clinical cure 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

MeasureTime frame
Clinical improvement 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

Countries

India

Contacts

Public ContactArijit Ghosh

Nilratan Sircar Medical College

drarijitghosh@gmail.com09874727137

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 25, 2026