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

• Status: Completed
• Trial end date: 2020-03-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ivano-Frankivsk National Medical University
• Collaborator: Bionorica SE

Criteria

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.