Bacteriophage Therapy in Tonsillitis

Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

Status and phase

Active, not recruiting

Phase 3

Conditions

Acute Tonsillitis

Treatments

Drug: Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.

Study type

Interventional

Funder types

Other

Identifiers

NCT04682964

TashkentPediatricMI

Details and patient eligibility

About

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.

Full description

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.

Enrollment

128 patients

Sex

All

Ages

3 to 14 years old

Volunteers

No Healthy Volunteers

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.