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Study of Imupret Application in the Technology of Delayed Prescription of Antibiotics in Patients With Acute Tonsillitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04537819
Recruitment Status : Completed
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Bionorica SE
Information provided by (Responsible Party):
Ivano-Frankivsk National Medical University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. - 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".

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children (males/females), 6 - 12 years old, with severe acute tonsillitis.
  • Possibility to initiate therapy within 72 hours since the onset of the disease symptoms.
  • Score 4-5 according to McIsaac Scale.
  • Patient's and (or) one of his/her parents' willingness and ability to fulfil the requirements of the Study Protocol.
  • Signed informed consent of the patient and (or) his/her parents for participation in the study.

Exclusion Criteria:

  • Score -1 to 3 according to McIsaac Scale.
  • Indication for hospitalization, including:

    • purulent complications (peritonsillar abscess and others);
    • severe general condition.
  • Indication for immediate initiation of systemic antibiotic therapy
  • patients at risk of developing severe complications, including e.g. clinically relevant concomitant diseases of heart, lungs, kidneys, liver, neuromuscular apparatus, cancer diseases, immunosuppression, diabetes mellitus, cystic fibrosis.
  • suspected infectious mononucleosis (by clinical signs);
  • use of systemic antibacterial or antifungal agents, systemic glucocorticosteroids, cytostatics, immunomodulatory drugs, "interferons" or interferon derivatives during the last 14 days prior to inclusion;
  • presence of haemorrhagic or pronounced necrotic process in oral cavity or pharynx, including the lymphoid ring.
  • Intolerability or individual hypersensitivity to any of the study drug ingredients and the reference treatment scheme.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04537819

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Ivano-Frankivsk National Medical University
Ivano-Frankivs'k, Ivano-Frankivsk, Ukraine
Sponsors and Collaborators
Ivano-Frankivsk National Medical University
Bionorica SE
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Principal Investigator: Vasyl Popovych Ivano-Frankivsk NMU
  Study Documents (Full-Text)

Documents provided by Ivano-Frankivsk National Medical University:
Study Protocol  [PDF] February 1, 2019
Statistical Analysis Plan  [PDF] February 7, 2019
Informed Consent Form  [PDF] February 7, 2019

Additional Information:
Publications of Results:
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Responsible Party: Ivano-Frankivsk National Medical University Identifier: NCT04537819    
Other Study ID Numbers: ATi-2
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivano-Frankivsk National Medical University:
Acute tonsillitis
Additional relevant MeSH terms:
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Peritonsillar Abscess
Respiratory Tract Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases