Treatment of chronic suppurative otitis media with the antimicrobial peptide OP-145 (AMP60.4Ac) in adults
| ISRCTN | ISRCTN12149720 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12149720 |
| Secondary identifying numbers | P02.216 |
- Submission date
- 13/10/2015
- Registration date
- 14/10/2015
- Last edited
- 07/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
Chronic suppurative otitis media (CSOM) is a long-lasting infection of the middle ear. The middle ear, also known as the tympanic cavity, is the name given to the air-filled space directly behind the ear drum. In CSOM, an infection leads to long-lasting irritation of this area causing pus to continually drain from the ear (suppuration) and even hearing loss in the affected ear. The first line treatment for CSOM is the use of antibiotics, which work to fight the infection. When antibiotics are used a lot, bacteria can become resistant to their effects, which make them much more difficult to treat. OP-145 is a new product which has been shown to be effective against harmful microorganisms and to reduce inflammation. The aim of this study is to find out whether OP-145-containing ear drops are an effective and safe treatment for CSOM in adults.
Who can participate?
Adults with chronic suppurative otitis media which is resistant to antibiotic treatment.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given OP-145 ear drops to use twice a day for two weeks. Those in the second group are given placebo (inactive medication) ear drops to use twice a day for two weeks. Participants in both groups are asked to attend a clinic at the start of the study and then again after 1, 2, 4, 8 and 12 weeks so that their ears can be examined to find out whether the ear drops have helped with treatment or have had any unwanted side effects.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Leiden University Medical Center (lead center) and six other medical centres in the Netherlands.
When is the study starting and how long is it expected to run for?
September 2006 to July 2007
Who is funding the study?
OctoPlus BV (Netherlands)
Who is the main contact?
1. Dr Peter Nibbering (Scientific)
2. Dr Nanno Peek (Scientific)
Contact information
Scientific
Leiden University Medical Center
Dept. of Infectious Diseases
Leiden
2300 rc
Netherlands
 ORCID ID |
0000-0002-0432-8340 |
|---|
Scientific
Reinier de Graaf Hospital
Reinier de Graafweg 5
Delft
2625 ad
Netherlands
| Phone | +31 15 2603060 |
|---|---|
| f.peek@dgg.nl |
Study information
| Study design | Randomized double-blind placebo-controlled multi-centre phase 2 study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Treatment of chronic suppurative otitis media with the antimicrobial peptide OP-145 (AMP60.4Ac) in adults |
| Study hypothesis | The aim of this study is to investigate the safety and efficacy of ear drops containing OP-145 in adults with chronic suppurative otitis media (CSOM). |
| Ethics approval(s) | Independent Ethics Committee of the Leiden University Medical Center, 20/06/2008, ref: P02-216 |
| Condition | Chronic suppurative otitis media (CSOM) |
| Intervention | Participants are randomly allocated to one of two groups. The first group receive the OP-145, reconstituted in eardrops at a concentration of 0.5 mg/ml, and the second group receive control ear drops which do not contain OP-145. Participants are asked to apply a few drops (± 100 μl) directly on the tympanic membrane, twice daily for 2 weeks, followed by 10 weeks follow-up. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | OP-145 |
| Primary outcome measure | Safety of the OP-145 was determined by recording adverse effects and concomitant medication, laboratory tests (specific peptide antibodies and general hematology), swabs from the middle ear and throat for bacterial culture and audiometry (including high pitch audiometry) at baseline 1, 2, 4, 8 and 12 weeks. |
| Secondary outcome measures | 1. Efficacy of the OP-145 in inducing improvement in the mucosa of the middle ear of adults with CSOM is measured by otoscopic inspections at baseline 1, 2, 4, 8 and 12 weeks. 2. Quality of life is determined using he SF-36, the chronic ear survey (CES) and the Brief Illness Perception Questionnaire (IPQ-b) at baseline 1, 2, 4, 8 and 12 weeks. |
| Overall study start date | 19/09/2006 |
| Overall study end date | 04/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 52 subjects |
| Total final enrolment | 50 |
| Participant inclusion criteria | 1. Aged 18 years or older 2. Legally competent, no psychiatric history 3. Diagnosis of CSOM with chronic proliferative mucosal changes > 6 months 4. A clear perforation of the tympanic membrane to allow proper inspection of the middle ear mucosa 5. Antibiotic therapy resistant (having received adequate treatment for CSOM for at least 2 periods of in total ≥ 6 weeks within the past year with at least two different ear drops and the last treatment period having occurred within the last 6 months before screening) |
| Participant exclusion criteria | 1. Cholesteatoma in the ear to be treated (i.e. CSOM with cholesteatoma) 2. Presence of a radical cavity in the ear to be treated 3. Use of systemic immune suppressants or antibiotics, use of topical antibiotics, corticosteroids or other eardrops in one of the ears until 4 weeks before study start 4. Down’s syndrome or other congenital anomalies to the external or middle ear or to the area of the “Eustachian tube – middle ear” of the ear to be treated 5. Presence of immune disorders, e.g. primary immune deficiency, immune proliferative disorders, Multiple Sclerosis, Crohn’s Disease, rheumatoid arthritis or Primary Ciliary Dyskinesia 6. Severe dizziness or severe headache, impacting on subjects’ daily life activities 7. Facialis nerve disorders on the side of the ear to be treated 8. Pregnancy, the wish to become pregnant or to breastfeed during the study, or, in case of a male subject, the wish to make his partner pregnant during the study 9. Prior participation in the dose-finding study of the program |
| Recruitment start date | 19/09/2006 |
| Recruitment end date | 15/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Rotterdam
3015 CE
Netherlands
Amsterdam
1081 HZ
Netherlands
Hoorn
1624 NP
Netherlands
Alkmaar
1815 JCL
Netherlands
Tilburg
5022 GC
Netherlands
Assen
9401 RK
Netherlands
Sponsor information
Industry
Zernikedreef 12
Leiden
2333cl
Netherlands
| Phone | +31 71 5244044 |
|---|---|
| verrijk@octoplus.nl | |
| Website | www.octoplus.nl |
"ROR" |
https://ror.org/01dn4wg45 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A poster (L1-3337) on the results of this study has been presented at ICAAC 2009. In addition, publication an open-access international journal is planned as soon as possible. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/04/2020 | 12/05/2021 | Yes | No | |
| Protocol (other) | 14/04/2020 | 07/11/2023 | No | No |
Editorial Notes
07/11/2023: Protocol added.
12/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
22/02/2019: Internal review.
