Health Condition 1: H661- Chronic tubotympanic suppurative otitis media
Conditions
Interventions
Intervention1: Amoxicillin- clavulanic acid: a single 625 mg tablet given orally twice a day for 7 days
Control Intervention1: Ciprofloxacin: 500mg tablet given orally twice a day for 7 days
Sponsors
Indira Gandhi Government medical college and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Participants to be attending the outpatient clinic in the department of ENT, 1. Adults of either sex, greater than 18 years 2. Clinically documented or New cases of a tubo-tympanic variety of CSOM with clinical signs & symptoms of the disease and baseline otological symptom score of >4 but = 8 were included in the study12 3. Patients willing to participate in the study by giving Informed consent 4. Outpatient department
Exclusion criteria
Exclusion criteria: 1. Atticoantral type of chronic suppurative otitis media 2. Age less than 18 years 3. Impending complications 4. Patients with acute otitis media and all physical and other subtypes of otitis media, such as otitis media with effusion. 5. Otomycosis 6. Severe cases of CSOM for which hospitalization or parenteral antibiotic treatment is required and patients with otological symptom score of =4 and >8 were also excluded from the study 7. Patients with foul-smelling Ear discharge 8. Large aural polyp in the middle ear 9. Patients who, received antibiotics either topical or systemic in the preceding 4 weeks of screening 10.Otological surgery within the past year 11. Presence of tympanostomy tube 12. Acute traumatic perforation 13. Symptomatic conditions such as otitis externa, chronic sinusitis, chronic pharyngitis requiring systemic antibiotic therapy that could interfere with the evaluation of study drugs 14. History of allergies to the study medication 15. Acute serious illness (like Myocardial Infarction, Stroke, Sepsis, Electrolyte disturbances) 16. Known case of any malignancy 17. Known case of any liver and kidney disease 18.Pregnant women and lactating mothers 19. Patients in Inpatient department 20. Underlying chronic diseases such as Diabetes mellitus, Tuberculosis 21. Known case of immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing complete stoppage of otorrhea at the end of 2 weeksTimepoint: reduction of otorrhea after 3 days, 1 week and 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Analyzing the cost-effective analysis of antimicrobialsTimepoint: cost effective analysis will be done at day 0 , day 3 , day7 and day 14;Ear discharge must be sterile or no pus after completion of course of treatment Timepoint: ear discharge will be swabbed at day 0 and day 14;Recording of adverse event, if any, according to the prescribed proforma issued by Pharmacovigilance program of India (PvPI).Timepoint: adverse drug reactions are noted at any point of time after drug intake | — |
Countries
India
Contacts
Public ContactSRIRAMAGIRI SAI VINAY
Indira Gandhi Government medical college and Hospital
Outcome results
None listed