Study of Imupret Application in the Technology of Delayed Prescription of Antibiotics in Patients With Acute Tonsillitis
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|ClinicalTrials.gov Identifier: NCT04537819|
Recruitment Status : Completed
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
The problem of acute tonsillitis (AT) is one of the most urgent in modern clinical medicine. The prevalence of pathology ranges from 2 to 15% of the total population.
AT (ICD J03.0-J03.9) in most cases is due to viral infections. Bacterial acute tonsillitis occurs in immunocompetent children in 20-30% of cases.
To determine the indications for antibacterial therapy, the Mclsaac scale is a commonly used tool for decision. This scale is used to classify patients according to their symptoms and to determine the patients for whom antibiotic therapy is not indicated.
Thus, in most cases of acute tonsillitis (even if there are 4-5 points according to the scale), it has to be taken into account that there is a low probability of the presence of GABS. Therefore, there are no unconditional indications for the prescription of antibiotics. Unjustified antibiotic therapy of AT plays a significant role in the formation of antibiotic resistance.
To prevent unjustified prescription of antibiotics, a therapeutic concept of delayed administration is proposed. A patient with AT is prescribed treatment with antibiotics in a delayed manner. In the absence of a positive effect within 36-48 hours from the beginning of treatment with Imupret, the antibacterial therapy is started. The advantage of deferred antibiotic prescription is, that a higher number of patients and doctors, awaiting antibiotic therapy, may be more agreeable with this way of treatment than with a complete rejection of the antibiotic's prescription. So delayed use of antibiotics is an important treatment strategy to reduce the number of unreasonable prescriptions of antibiotics.
Considering this fact, it becomes necessary to use drugs with a complex effect and evidence-based efficacy base for acute tonsillitis. At the moment, there is an insignificant evidence base for the application of the phytoneering drug Imupret in acute tonsillitis. The spectrum of its pharmacological properties includes antiviral, antibacterial, anti-inflammatory, and immunomodulating effects. The combination of these properties makes it possible to influence practically all parts of acute tonsillitis. The already existing studies were not conducted under GCP conditions. Confirmation of the high effectiveness of Imupret in the treatment of acute tonsillitis would serve as a rationale for optimizing the treatment regimen of this nosology and recommendations for the inclusion of the drug in national guidelines.
|Condition or disease||Intervention/treatment||Phase|
|Acute Tonsillitis||Drug: Imupret in addition to local NAID Drug: Local NAID (Benzydamin)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open, Comparative Study of Efficacy, Safety and Tolerability of Imupret Application in the Concept of Delayed Prescription of Antibiotics in Children, Aged 6-12 With Acute Tonsillitis|
|Actual Study Start Date :||March 20, 2019|
|Actual Primary Completion Date :||January 20, 2020|
|Actual Study Completion Date :||March 25, 2020|
Experimental: The main group
1. soft diet; 2. Elimination of factors that irritate the mucous membrane of the pharynx (thermal, chemical); 4. Local NSAIDs - benzydamine hydrochloride. 5. Imupret oral drops in the age-related dosage of 6 times per day for 6 days with the subsequent transition to the regime of 15 drops / 3 times in a day according to the patient's condition.
6. Paracetamol as antipyretic, if necessary.
Drug: Imupret in addition to local NAID
Additional prescription of Imupret oral drops to conventional therapy with local NAID (Benzydamine hydrochloridy), elimination of irritating factors in the diet and acetaminophen (if necessary)
Other Name: BNO 1030 extract from 7 plants (active substance of Imupret)
The comparison group
1. soft diet; 2. Elimination of factors that irritate the mucous membrane of the pharynx (thermal, chemical); 4. Local NSAIDs - benzydamine hydrochloride. 5. Paracetamol as antipyretic, if necessary.
Drug: Local NAID (Benzydamin)
(Benzydamine hydrochloridy) and acetaminophen (if necessary), elimination of irritating factors in the diet
Other Name: Tantum Verde
- - Changes in the severity of each symptom (complaint). [ Time Frame: Day 1; 3; 5; 10; 28 ]- Changes in the severity of each symptom (complaint; 0 - 4 points per symptom) that is part of the Acute tonsilitis severity scale of tonsillitis manifestations, up to 1 point or less. This variable is dichotomous, with the categories "treatment effective" and "treatment not effective".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537819
|Ivano-Frankivsk National Medical University|
|Ivano-Frankivs'k, Ivano-Frankivsk, Ukraine|
|Principal Investigator:||Vasyl Popovych||Ivano-Frankivsk NMU|