Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609866048204 Date of Registration: 10/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title STOP Trial
Official scientific title Effectiveness of self-administered iodine drops for management of ear discharge in Chronic Suppurative Otitis Media in communities in Zambia
Brief summary describing the background and objectives of the trial This trial (the STOP Trial) addresses Chronic Suppurative Otitis Media (CSOM), a neglected but common cause of ear discharge and hearing loss in Zambia and other low- and middle-income countries, where limited ENT specialist capacity and the high cost, poor availability, and cold-chain requirements of standard topical ciprofloxacin restrict access to treatment, particularly in rural communities; as an alternative, 5% topical povidone-iodine is far cheaper, more widely available, and WHO-recommended for CSOM, but has traditionally required health-facility-based administration and has only been tested in small, short-term, inconclusive trials, so this study evaluates community-based self-administration of 5% topical iodine for the first time in an LMIC setting, with the general objective of assessing its effectiveness in resolving ear discharge, and specific objectives to determine its non-inferiority to topical ciprofloxacin (within a 10% margin) for treating ear discharge, examine factors associated with treatment failure, assess the acceptability of self-administered iodine among community members, and assess its safety.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Chronic Suppurative Otitis Media
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2026
Actual trial start date
Anticipated date of last follow up 31/12/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Saline drops Dose: 3 drops per ear Frequency: every 8 hours 7 days Participants randomized to the control arm will receive 0.9% saline solution administered as ear drops, three drops per ear every 8 hours for one week, following ear toileting with a tissue wick. While serving as the comparator arm, saline irrigation is a recognized standard component of chronic suppurative otitis media (CSOM) management per WHO's ear and hearing care guidelines and may itself have a therapeutic irrigating effect; existing evidence is insufficient to conclude it is inferior to active antimicrobial treatment. This is a feasibility design with pre-specified interim monitoring by an independent committee: if saline irrigation proves clearly inferior, participants in this arm will cross over to active treatment and the definitive trial will proceed as a two-arm comparison of ciprofloxacin versus iodine. 60 Active-Treatment of Control Group
Experimental Group Arm 1 5 percent topical povidone iodine solution 3 3 drops per ear, every 8 hours 7 days Participants randomized to this arm will receive 5% topical povidone-iodine (PVP-I) solution administered as ear drops, three drops per ear every 8 hours for one week, following ear toileting with a tissue wick. PVP-I is a widely available, cost-effective antiseptic with broad-spectrum antimicrobial activity and no documented microbial resistance; existing evidence supports its safety at this concentration and shows efficacy comparable to topical antibiotics in the management of chronic suppurative otitis media (CSOM). Administration will be self- or caregiver-delivered in the community, guided by pictorial instructions in line with WHO ear and hearing care recommendations, with adherence and safety monitored through scheduled home visits by trained community-based volunteers. 60
Experimental Group Arm 3 0.3 percent ciprofloxacin 3 drops per ear, every 8 hours 7 days Participants randomized to this arm will receive 0.3% ciprofloxacin ear drops, three drops per ear every 8 hours for one week, following ear toileting with a tissue wick. Ciprofloxacin is the current standard-of-care topical antibiotic for chronic suppurative otitis media (CSOM) and has demonstrated effectiveness against commonly isolated causative organisms, including in Zambian clinical settings. This arm serves as the active standard-treatment comparator against the two alternative, more accessible interventions (topical iodine and saline). Administration will be self- or caregiver-delivered in the community, guided by pictorial instructions in line with WHO ear and hearing care recommendations, with adherence and safety monitored through scheduled home visits by trained community-based volunteers. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with CSOM (otorrhoea from the middle ear for >2 weeks through a perforated eardrum) Treated for ear infection or received antibiotics for any other disease in the previous 2 weeks Other ear problems, e.g., external ear infection, tumours, or craniofacial malformation - History of otologic surgery - History or presence of cholesteatoma - Exposure to any investigational agent within 90 days before study entry - Presence of a tympanostomy tube - Known allergy to study drugs 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 5 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/12/2025 University of Zambia Biomedical Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Zambia, School of Medcine Ridgeway Campus off Nationalist road Lusaka Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Dry ear by week 2, confirmed by video otoscopy (i.e., the proportion of participants achieving resolution of ear discharge) at week 2
Secondary Outcome Change in hearing threshold (decibels/frequencies, via audiograms) - Self-reported time taken for the ear to dry (patient/caregiver journaling) - Recurrence rate of otorrhoea at 3 or 6 months - Mean change in tympanic membrane perforation size - Microbial resistance patterns in persistent or recurrent otorrhoea - Adverse effects of treatments (dizziness, tinnitus, pain, irritation, skin reaction) Baseline, Day 14 Week 2, Month 3, and Month 6 clinical assessments video otoscopy, TM perforation grading, and pure-tone audiometry ages 5 and abo Baseline and follow up visits microbiology samplin
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zambart Zambart House, University of Zambia, School of Medicine, Ridgeway Campus off Nationalist Road, Lusaka Central Province Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health and Care Research NIHR Cambridge Biomedical Research Centre, Box 277, Hills Road, Cambridge CB2 0QQ United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zambart Zambart House, University of Zambia, School of Medicine, Ridgeway Campus off Nationalist Road, Lusaka Central Province Zambia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
The University of Sussex Sussex House, Falmer, Brighton BN1 9RH United Kingdom
Cambodia university of technology and science CamTech Street, Sangkat Prek Tasek, Khan Chroy Changvar Phnom Penh 121003 Cambodia
University of Malawi Chirunga Road, Zomba Zomba Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Racheal Hapunda Racheal@zambart.org.zm 00260211254710 University of Zambia School of Medicine Ridgeway Campus off nationalist road
City Postal code Country Position/Affiliation
lusaka Zambia Researcher
Role Name Email Phone Street address
Public Enquiries Kwame Shanaube Kshanaube@zambart.org.zm +260211254710 university of zambia off nationalist road
City Postal code Country Position/Affiliation
Lusaka Zambia Executive Director
Role Name Email Phone Street address
Scientific Enquiries Mohammed Limbada Mohammed@zambart.org.zm +260211254710 Ridgeway Campus Off Nationalist Road,
City Postal code Country Position/Affiliation
Lusaka Zambia Head of Unit
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data, along with the study protocol and statistical analysis plan, will be made available upon reasonable request to the Principal Investigator following completion and publication of the primary study results, subject to a data access agreement and approval by the University of Zambia's Data Management Committee Clinical Study Report,Informed Consent Form,Study Protocol Data will be available beginning 12 months after publication of the primary results, for a period of 5 years thereafter. De-identified individual participant data will be made available to researchers who provide a methodologically sound proposal, subject to approval by the Principal Investigator and the study's Data Management Committee. Requests must include a signed data access agreement specifying the intended use, and approval will be conditional on the proposed use being consistent with the original ethics approval and participant consent.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information