Bacteriophage Therapy in Tonsillitis

NCT04682964 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: TashkentPediatricMI
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Tonsillitis

Keywords

acute tonsillitis; children; bacteriophage; immunity; ambulatory treatment

Outcome Measures

Primary Outcomes (3)

• Clinical observation of sick children.

  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).

  study of one patient - 4 weeks

• Laboratory research methods.

  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.

  study of one patient - 2 weeks

• Experimental clinical stage. Bacteriophage therapy.

  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.

  study of one patient - 4 weeks

Secondary Outcomes (1)

• The second stage of the study (statistical).

  4 weeks

Study Arms (1)

Nebulizer inhalation bacteriophage therapy

EXPERIMENTAL

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

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

Interventions

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

Also known as: Bacteriophage therapy.

Nebulizer inhalation bacteriophage therapy

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan: lead

Study Sites (1)

Tashkent Pediatric Medical Institute

Tashkent, 100140, Uzbekistan

Location

MeSH Terms

Interventions

Phage Therapy

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Shokhida T. Turdieva, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: МD, associate professor of the Department "Outpatient care"

Model Details: Children aged 3 to 14 years with clinically diagnosed acute tonsillitis will receive bacteriophage therapy using a liquid pyobacteriophage complex (liquid pyobacteriophage complex - PCL).

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 24, 2020
• Study Start: October 2, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2021-2024
• Access Criteria: Children 0-17 years old, after being diagnosed with COVID-19, with a bacterial infection of the upper respiratory tract. We will work together with children's hospitals and research centers.

Locations

UZ (1)