Clinical trial NCT04682964: Bacteriophage Therapy in Tonsillitis
Official title: Bacteriophage Therapy in Acute Tonsillitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Tonsillitis
Keywords: acute tonsillitis
children
bacteriophage
immunity
ambulatory treatment
Lead sponsor: Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 128
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Children aged 3 to 14 years with clinically diagnosed acute tonsillitis will receive bacteriophage therapy using a liquid pyobacteriophage complex (liquid pyobacteriophage complex - PCL).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Clinical observation of sick children.
timeFrame: study of one patient - 4 weeks
measure: Laboratory research methods.
timeFrame: study of one patient - 2 weeks
measure: Experimental clinical stage. Bacteriophage therapy.
timeFrame: study of one patient - 4 weeks
Secondary outcomes:
measure: The second stage of the study (statistical).
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Tashkent Pediatric Medical Institute
Study officials:
affiliation: Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
name: Shokhida T. Turdieva, MD
role: STUDY_DIRECTOR
References: