Bacteriophage Therapy in Tonsillitis

NCT ID: NCT04682964

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-02
• Study Completion Date: 2028-12-31

Brief Summary

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.

Detailed 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.

Conditions

Acute Tonsillitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nebulizer inhalation bacteriophage therapy

To study the effects of bacteriophage therapy on acute tonsillitis in children and adolescents in an outpatient setting.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Bacteriophage therapy.

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Turdieva Shokhida Tolkunovna, MD

МD, associate professor of the Department "Outpatient care"

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shokhida T. Turdieva, MD

Role: STUDY_DIRECTOR

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

Locations

Tashkent Pediatric Medical Institute

Tashkent, , Uzbekistan

Countries

Uzbekistan

Other Identifiers

TashkentPediatricMI

Identifier Type: -

Identifier Source: org_study_id