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Trial details
The Efficacy of Octenidine in Sinusitis compared to standard of care
Current status:
Approved
|
Date registered:
20/02/2020
|
Date last updated:
18/02/2020
Trial version(s)
Current: 08/02/2020
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Main Information
Primary registry identifying number
LBCTR2020023398
Protocol number
LAUMCRH.RH2.4/Dec/2019
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
01/03/2020
Primary sponsor
Schülke
Primary sponsor: Country of origin
Germany
Public title
The Efficacy of Octenidine in Sinusitis compared to standard of care
Acronym
Scientific title
The Efficacy of Octenidine in Sinusitis compared to standard of care
Acronym
Brief summary of the study: English
Rhinosinusits is one of the most common infections worldwide treated mainly with antibiotics. In the era of emerging antibiotic resistance, we should be more meticulous in prescribing antibiotics. Antiseptics are another antibiotic sparing strategy especially when used locally in wounds and other sites of infection like the sinuses. Octenidine, the active ingredient in Octenisan nasal gel, is an antiseptic that has been tested and used on human skin and wounds for many years. It is very effective in eradicating bacterial pathogens, and above all, it is safe to use on mucosal surfaces. The purpose of this study is to assess the efficacy of this gel in treating acute bacterial rhinosinusitis or exacerbations of chronic rhinosinusitis.
Brief summary of the study: Arabic
يعدّ التهاب الجيوب الأنفية من أكثر الالتهابات التي يتم علاجها بالمضادات الحيوية عادة. في وقت تظهر فيه مقاومة للمضادات الحيوية أكثر فأكثر، يجب علينا أن نكون حذرين جداً عند وصف المضادات الحيوية. وتعتبر المطهرات استراتيجية أخرى لنتفادى بها المضادات الحيوية، لا سيّما عند استخدامها بطريقة موضعية على الجروح ومواقع التهابات أخرى مثل الجيوب الأنفية. ويعدّ الأوكتنيدين، المكوّن الفعّال في جل أوكتنيسان للأنف، مطهّراً تم اختباره واستخدامه على البشر لسنوات عديدة. إنه فعّال جداً في إزالة البكتيريا المسببة للأمراض، والأهم يمكن استخدامه على الأسطح المخاطية بكل أمان. الغرض من هذه الدراسة هو تقييم فاعلية هذا الجل في علاج التهاب الجيوب الأنفية الحاد أو حالات تفاقم التهاب الجيوب الأنفية المزمن.
Health conditions/problem studied: Specify
Acute Bacterial Rhinosinusitis ARS is defined as symptomatic inflammation of the nasal cavity and paranasal sinuses that lasts less than four weeks. The most common etiology of ARS is viral; hence the treatment focuses on symptomatic management as it typically resolves within 7-10 days. Acute Bacterial Rhinosinusitis (ABRS) occurs in about 0.5-2%. Patients with ABRS are observed or treated with antibiotics. According to the Infectious Disease Society of America we start antibiotic therapy after diagnosis for patients who do not have good follow up, in patients who have been observed and who have worsening symptoms or fail to improve within a seven-day period or patients with severe symptoms Exacerbations of Chronic Rhinosinusitis Chronic rhinosinusitis (CRS) may be broadly defined as an inflammatory disorder of the paranasal sinuses and linings of the nasal passages that lasts 12 weeks or longer. More precisely, it is a heterogeneous group of related disorders that share certain clinical and pathologic features.
Interventions: Specify
Patients will be recruited from multiple departments: ENT, Family Medicine, Infectious Diseases and Emergency Medicine. After determining if the patient falls under the guidelines of ABRS or CRS exacerbation described in the introduction stated above, they will be randomly assigned to receive either standard of care or Octenidine. The patients’ SNOT22 score will be calculated and few questions about the patients’ demographics will be answered before the treatment starts (initial assessment). (T0) Four days after initiating the treatment, a follow up phone call will be conducted to ask few questions and calculate the new SNOT22 score. An average of the new SNOT22 score for both groups will be calculated. A difference of 10% or less will be considered as insignificant concluding that Octenidine is as effective as antibiotics with the benefit of reducing antibiotic resistance. We will also report the number of patients who dropped out or were switched to a different treatment. (T1) Ten days after initiating treatment (last day of treatment) the same process that was carried out on day 4 will be conducted again and the results will be reported. (T2) Two weeks after stopping treatment, the same process will be carried out. (T3) Octenidine will be given twice per day for 10 days. It is applied in each nostril posteriorly, followed by a gentle squeeze on the anterior nares to push the gel into the nasal cavity. After few minutes, due to body temperature, the gel may liquify and run through the nostrils. In that case, the patient is advised to wipe gently using a tissue without blowing their nose and flushing the gel out.
Key inclusion and exclusion criteria: Inclusion criteria
CRS: Patients (male or female) at the age of 18 or above who fit the criteria for exacerbation in CRS : Twelve weeks or longer of two or more of the following signs and symptoms: o mucopurulent drainage (anterior, posterior, or both) o nasal obstruction (congestion) o facial pain-pressure-fullness o decreased sense of smell. AND inflammation is documented by one or more of the following findings: o purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region. o radiographic imaging showing inflammation of the paranasal sinuses. ABRS: Patients at the age of 18 or above who fit the criteria for ABRS
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion criteria for both ABRS and CRS: o Patients who are below the age of 18. o Patients who are pregnant. o Patients who have received antibiotics. o Patients who are immunocompromised. o Patients who have high grade fever defined as 38.5C and above o Patients with known allergy to octenidine. o Patients with contraindications to octenidine. o Patients who scored severe on the SNOT22 score o Patients who are receiving systemic glucocorticoid therapy.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Worldwide
Name of IMP
Octenidine
Type of IMP
Others
Type of IMP: Specify
Antiseptic
Pharmaceutical class
Antiseptic and Disinfectant
Therapeutic indication
Octenidine is an established antiseptic to be used on the skin, mucous membranes and wounds prophylactically as well as therapeutically in a growing field of applications and could replace classical antiseptics like chlorhexidine. It is easy and safe to handle, chemically stable, not inflammable, without resistance development and low toxicity to man and the environment alike. Octenisan Nasal Gel is used for moistening and decontamination of nasal vestibules by physical cleansing and supportive wound treatment of lesions of the nasal epithelium.
Therapeutic benefit
Possible treatment of bacterial rhinosinusitis without the use of antibiotics, in the era of antimicrobial resistance and multidrug resistant organisms
Biospecimen retention
None retained
Biospecimen description
None retained
Target sample size
40
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
02/03/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
01/03/2021
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
NA
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
LAU IRB
LAUMCRH.RH2.4/Dec/2019
Sources of Monetary or Material Support
Name
Schulke company will provide the Octenisan Nasal Gel free of charge for the use in the study. There is no other additional monetary support.
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Harout
Kolanjian
LAUMC-RH, Zahar Street, Achrafieh
Lebanon
01 200 800
harout.kolanjian@lau.edu
LAUMC-RH
Scientific
Roula
Husni - Samaha
LAUMC-RH, Zahar Street, Achrafieh
Lebanon
01 200 800
roula.samaha@laumcrh.com
LAUMC-RH
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
LAUMC-RH
Roula Husni Samaha
Infectious Diseases
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
04/12/2019
Christine Chalhoub
christine.chalhoub@lau.edu.lb
+961 9 547254 ext. 2340
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Acute Bacterial Rhinoosinusitis
Acute sinusitis (J01)
ABRS
Chronic Rhinosinusitis
Chronic sinusitis (J32)
CRS
Interventions
Intervention
Description
Keyword
Octenidine
Intranasal application of Octenidine twice daily for ten days
Group 1
Standard of Care
The use of oral antibiotics for treatment of bacterial sinusitis (standard of care)
Group 2
Primary Outcomes
Name
Time points
Measure
Treatment of Rhinosinusitis
10 days
change in SNOT22 score
Key Secondary Outcomes
Name
Time points
Measure
Decreasing the use of antibiotics, and hence decreasing the antimicrobial resistance on the long run
years
Antibiotic susceptibility profile of pathogens
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial