The Efficacy of Octenidine in Sinusitis compared to standard of care

Authors
Category Primary study
Registry of TrialsLebanese Clinical Trials Registry
Year 2020
INTERVENTION: Group 1 Group 2 Intranasal application of Octenidine twice daily for ten days 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. The use of oral antibiotics for treatment of bacterial sinusitis (standard of care) CONDITION: ABRS 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. ; ABRS ; CRS PRIMARY OUTCOME: Name: Treatment of Rhinosinusitis;Timepoints: 10 days;Measure: change in SNOT22 score SECONDARY OUTCOME: Name: Decreasing the use of antibiotics, and hence decreasing the antimicrobial resistance on the long run;Timepoints: years;Measure: Antibiotic susceptibility profile of pathogens 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
Epistemonikos ID: 0e6264e2137d11743d93f2ca1badd209a8e6318c
First added on: Aug 24, 2024