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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- - Changes in the severity of each symptom (complaint).
研究概览
简要总结
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.
详细描述
Study of Therapeutic Efficacy, Safety, and Tolerability of Imupret application in the therapeutic concept of delayed prescription of antibiotics in patients with severe acute tonsillitis in children, aged 6-12.
Acute tonsillitis in most cases is due to viral infections. Bacterial tonsillitis occurs in immunocompetent children in 20-30% of cases, adults - in 5-15%, and the most frequent cause of it is β-hemolytic streptococcus group A (GABS).
Acute tonsillitis is defined as the sudden appearance of the following symptoms: sore throat, hyperemia, edema of the tonsils, increase in swollen lymph nodes, and non-specific additional symptoms like fever, weakness, and joint pain. There are no pathognomonic symptoms of bacterial tonsillitis. To assess the patient's condition and 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.
McIsaac scale (sum of scores) The probability of the identification of β-hemolytic streptococcus in a smear from pharynx -1 or 0 - 1% 1-10% 2 ~17% 3 ~35% 4 or 5 ~50% Thus, in most cases of acute tonsillitis (even if there are 4-5 points according to the scale), it must be considered 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 acute tonsillitis based on "sore throat" or "exudate (plaque) tonsils" only does not affect pain and lads the formation of antibiotic resistance. In order to avoid the irrational use of antibiotics, one should distinguish the desire of the patient or his parents to get rid of the pain, from the rational assessment of the doctor for all pros and cons about an antibacterial therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The main group
-
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.
-
Paracetamol as antipyretic, if necessary.
干预措施: Imupret in addition to local NAID (Drug)
The comparison group
- 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.
干预措施: Local NAID (Benzydamin) (Drug)
结局指标
主要结局
- Changes in the severity of each symptom (complaint).
时间窗: 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".
次要结局
未报告次要终点