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

NCT04537819 | Completed

• 1 other identifier: ATi-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Tonsillitis

Keywords

Acute tonsillitis; antibiotics; phytotherapy

Outcome Measures

Primary Outcomes (1)

• - Changes in the severity of each symptom (complaint).

  \- 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".

  Day 1; 3; 5; 10; 28

Study Arms (2)

The main group

EXPERIMENTAL

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

The comparison group

OTHER

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)

Interventions

Imupret in addition to local NAID DRUG

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)

Also known as: BNO 1030 extract from 7 plants (active substance of Imupret)

The main group

Local NAID (Benzydamin) DRUG

(Benzydamine hydrochloridy) and acetaminophen (if necessary), elimination of irritating factors in the diet

Also known as: Tantum Verde

The comparison group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Ivano-Frankivsk National Medical University: lead
• Bionorica SE: collaborator

Study Sites (1)

Ivano-Frankivsk National Medical University

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Location

Related Publications (1)

• Abdulkerimov KT, Kartashova KI, Davydov RS, Abdulkerimov ZK, Kolesnikova AV, Yusupova DR. [The comparative evaluation of the effectiveness of the treatment of the patients presenting with the sub-compensated form of chronic tonsillitis making use of the antiseptic herbal medicinal product in the combination with the standard conservative therapy: the results of the open randomized study]. Vestn Otorinolaringol. 2018;83(3):45-49. doi: 10.17116/otorino201883345. Russian.

  PMID: 29953055 RESULT

Related Links

• Effectiveness and tolerability of Tonsilgon® N in the treatment of recurrent upper res-piratory tract infections in children: A non-interventional study in Russia, Clinical Phy-toscience (2016)

MeSH Terms

Interventions

imupret

Study Officials

• Vasyl Popovych

  Ivano-Frankivsk NMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: September 3, 2020
• Study Start: March 20, 2019
• Primary Completion: January 20, 2020
• Study Completion: March 25, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)