Bacteriophage Therapy in Acute Tonsillitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Experimental clinical stage. Bacteriophage therapy.
研究概览
简要总结
The patients received bacteriophage therapy with a liquid piobacteriophage complex (liquid pyobacteriophage complex - PCL). PСL was administered via nebulizer inhalation to irrigate the tonsil mucosa. A total of 5 ml of PCL was inhaled for 10 minutes every 5 days. The drug causes the lysis of certain bacteria, including staphylococcus, enterococcus, streptococcus, enteropathogenic E. coli, Proteus vulgaris, Proteus mirabilis, Pseudomonas aeruginosa, Klebsiella pneumoniae and Klebsiella oxytoca. The choice of this drug was based on bacteriological studies.
详细描述
Comprehensive outpatient treatment was based on standard clinical guidelines, and symptomatic treatment was performed. On the first day of diagnosis, patients were prescribed complex antibacterial therapy on the basis of possible causative agents. Subsequently, antibiotic therapy was adjusted based on the results of the bacteriological examinations. A total of 67 patients received bacteriophage therapy using a liquid complex of pyobacteriophages (pyobacteriophage complex liquid - PСL). PСL was administered via nebulizer inhalation to irrigate the mucous membranes of the tonsils. In total, 5 ml of PCL was inhaled for up to 10 minutes once every 5 days.
The drug causes lysis of specific bacteria including Staphylococcus, Enterococcus, Streptococcus, enteropathogenic Escherichia coli, Proteus vulgaris, Proteus mirabilis, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Klebsiella oxytoca. The drug is recommended for use for diseases of the ear, throat, nose, respiratory tract and lungs; inflammation of the sinuses and middle ear; tonsillitis; pharyngitis; laryngitis; tracheitis; bronchitis; pneumonia, pleurisy; and other inflammatory diseases. The choice of this drug was based on bacteriological studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children from 3 to 14 years old.
- •children with sore throat.
- •children diagnosed with acute tonsillitis.
- •children diagnosed with acute respiratory infection (rhinitis, sinusitis, nasopharyngitis).
- •children with the opportunity to visit the outpatient clinic.
- •children with the ability to receive inhalation therapy.
- •children from parents (or guardians) who have given written permission to conduct clinical and laboratory research.
排除标准
- •children under 3 years old and over 14 years old.
- •children receiving hospital treatment.
- •children with acute respiratory tract diseases (bronchitis, pneumonia, pleurisy).
- •children with сhronic respiratory tract diseases (bronchitis, pneumonia).
- •children who are allergic to antibiotics.
- •children with cancer, immunological and hematological diseases.
- •children with severe psychological illnesses (schizophrenia, mental retardation, etc.)
- •children with cancer, immunological and hematological diseases.
- •children with tuberculosis.
研究组 & 干预措施
Nebulizer inhalation bacteriophage therapy
To study the effects of bacteriophage therapy on acute tonsillitis in children and adolescents in an outpatient setting.
干预措施: Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage. (Drug)
结局指标
主要结局
Experimental clinical stage. Bacteriophage therapy.
时间窗: study of one patient - 4 weeks
Comprehensive outpatient treatment will be based on standard clinical guidelines. Patients will be prescribed antibiotic therapy based on possible pathogens. Patients will receive bacteriophage therapy using a liquid pyobacteriophage complex (liquid pyobacteriophage complex - PCL), through nebulizer inhalation to irrigate the mucous membranes of the tonsils. Just 5 ml PCL for 10 minutes once every 5 days. Efficacy will be studied based on immunological studies.A study of cellular (class of T-lymphocytes, Inflammatory cytokines (e.g., IL-1,2,4,5,6,11,13 - U/ml) and TNF-α) and humoral ( IgA / IgM / IgG -IU/mL) immunity in children will be carried out, using (Enzyme Linked Immunosorbent Assay) ELISA which is an immunoassay, suited to the determination of antibodies in the field of infectious serology.
Clinical observation of sick children.
时间窗: study of one patient - 4 weeks
Children with clinically diagnosed acute tonsillitis are examined. The clinical study will be carried out on an outpatient basis in cooperation with the clinic of the Tashkent Pediatric Medical Institute. Prior to the study, written permission will be obtained from the parents or guardians of the children to participate in the study. Investigated: anamnesis of the child, the course of the disease, complaints of parents about the child's condition, body temperature in dynamics, visually - the state of the nasopharynx, the manifestation of clinical symptoms (sore throat, headaches, difficulty swallowing food, aphonia, and other signs) in dynamics, the functional state of internal organs (percussion, palpation and auscultation).
Laboratory research methods.
时间窗: study of one patient - 2 weeks
All examined children will undergo general clinical examination and pharyngoscopy. Additionally, all patients will have tonsil swabs for bacteriological examination (bacteriological culture, n x 10⁴/mL ) according to the standard technique. Also, swabs from the nasopharynx will be taken for viral lesions by the standard method - PCR (polymerase chain reaction). The research will be carried out in specialized laboratories.
次要结局
- The second stage of the study (statistical).(4 weeks)
研究者
Turdieva Shokhida Tolkunovna, MD
МD, associate professor of the Department "Outpatient care"
Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan