Efficacy of Povidone-Iodine Ear Wash and Oral Co-trimoxazole in the Management of Chronic Suppurative Otitis Media in Nigerian Children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202412520985506

Enrollment

280

Registered

2024-12-17

Start date

2025-01-13

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Ear, Nose and Throat

Interventions

Cotrimoxazole and Standard Treatment

Povidone Iodine Ear Wash and Standard Treatment

Oral Cotrimoxazole and Dilute Povidone Iodine Ear Wash and Standard Treatment

Standard Treatment Comprising of Topical Ciprofloxacin and Dry Mopping

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Paediatric patients, attending the ENT Outpatient Clinic, Paediatric Outpatient Clinic and General Outpatient Department in the Nigerian Air Force Hospital, Ikeja presenting with a clinical diagnosis of Chronic Suppurative Otitis Media will be recruited into the study.

Exclusion criteria

Exclusion criteria: 1. Previously randomised patients in this study. 2. Non – suppurative ear disease. 3. Patients with otitis externa. 4. Mastoid or tympanoplasty surgery in the last 12 months. 5. Congenital ear or hearing problems. 6. Known Immunodeficiency. 7. Pregnancy. 8. Patients with ciprofloxacin, cotrimoxazole or iodine allergy.

Design outcomes

Primary

Measure	Time frame
The proportion of children with clinical failure of CSOM after treatment.	—

Secondary

Measure	Time frame
The proportion of clinical CSOM that fail to improve (determined by perforation size, amount of discharge, time to cessation of discharge).	—

Countries

Nigeria

Contacts

Public ContactSemen Stephen Yikawe

Consultant ENT Surgeon

syikawe@gmail.com+2348034679515

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026