Acute TonsillitisPhase 3NCT04682964
Bacteriophage Therapy in Tonsillitis
A Phase 3 study testing Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage. in people with Acute Tonsillitis, run by Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan at 1 site in Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Acute Tonsillitis
- What is being tested?
- Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUzbekistan
- Study dates
- 2 Oct 2020to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- children with severe psychological illnesses (schizophrenia, mental retardation, etc.)
- children with cancer, immunological and hematological diseases.
- children with tuberculosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacteriophage Therapy in Acute Tonsillitis
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.
Read the 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
- Being tested
- Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.
- Keywords
- acute tonsillitis, children, bacteriophage, immunity, ambulatory treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.Drug
Also called Bacteriophage therapy.
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.
| Study group | Role | What they receive |
|---|---|---|
| Nebulizer inhalation bacteriophage therapy | Experimental | To study the effects of bacteriophage therapy on acute tonsillitis in children and adolescents in an outpatient setting. Receives: Drug: Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: study of one patient - 4 weeks
Secondary outcomes (1)
The second stage of the study (statistical).
The results will be analyzed using a statistical program based on Excel 2017 (Microsoft Office 2017). Clinical signs will be calculated as a percentage (%) incidence. We will calculate the chi-square (χ2) test or Fisher's exact test (for expected values <5) to assess if certain pairs of microbes are more common than expected by chance in bacteriological examination. In addition, we will use the Kruskal-Wallis test to compare the average delay between disease onset and sample collection between samples containing one or more organisms. When evaluating immunological analyzes, characterizing the statistical significance of differences, the Student's t-test will be used with the definition of the confidence interval. The X-square test will be used to assess the frequency of identifying qualitative features. In all analyzes, P ≤ 0.05 was considered significant.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start2 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turdieva Shokhida Tolkunovna, MD, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
- Investigators
- Shokhida T. Turdieva, MD, Study director, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682964
- Sponsor's protocol ID
- TashkentPediatricMI
- Status last verified
- May 2025
- First submitted
- 9 Dec 2020
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are planning to create a joint project to research the treatment of bacterial infection in children with respiratory diseases by COVED-19.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriophage Therapy in Acute Tonsillitis
- ClinicalTrials.gov ID
- NCT04682964
- Acronym / sponsor ID
- TashkentPediatricMI
- Conditions
- Acute Tonsillitis
- Keywords
- acute tonsillitis, children, bacteriophage, immunity, ambulatory treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Tashkent State Medical University (Tashkent Pediatric Medical Institute), UzbekistanUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Nebulizer inhalation bacteriophage therapy | Experimental | Drug: Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.To study the effects of bacteriophage therapy on acute tonsillitis in children and adolescents in an outpatient setting. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.Also: Bacteriophage therapy.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. | Drug | Nebulizer inhalation bacteriophage therapy |
Primary outcome
Clinical observation of sick children.
Time frame: study of one patient - 4 weeks
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).
Laboratory research methods.
Time frame: study of one patient - 2 weeks
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.
Experimental clinical stage. Bacteriophage therapy.
Time frame: study of one patient - 4 weeks
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.
1 secondary outcome
The second stage of the study (statistical).
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. We are planning to create a joint project to research the treatment of bacterial infection in children with respiratory diseases by COVED-19.
Related trials for Acute Tonsillitis
Not yet recruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
Recruiting
Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis
Acute Pharyngitis, Viral Sore Throat
RecruitingPhase 4
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute
Not yet recruitingObservational study
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center
Tonsillitis Acute, Pneumonia - Bacterial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shokhida T. Turdieva, MD study director
Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage. in people with Acute Tonsillitis, run by Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical observation of sick children. (time frame: study of one patient - 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.