Clinical trial
Bacteriophage Therapy in Acute Tonsillitis
Name
TashkentPediatricMI
Description
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.
Trial arms
Trial start
2020-10-02
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.
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.
Arms:
Nebulizer inhalation bacteriophage therapy
Other names:
Bacteriophage therapy.
Size
128
Primary endpoint
Clinical observation of sick children.
study of one patient - 4 weeks
Laboratory research methods.
study of one patient - 2 weeks
Experimental clinical stage. Bacteriophage therapy.
study of one patient - 4 weeks
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Children aged 3 to 14 years with clinically diagnosed acute tonsillitis will receive bacteriophage therapy using a liquid pyobacteriophage complex (liquid pyobacteriophage complex - PCL).', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 128, 'type': 'ACTUAL'}}
Updated at
2023-12-21
1 organization
1 product
1 indication
Organization
Tashkent Pediatric Medical InstituteIndication
Tonsillitis