NCT04682964

Bacteriophage Therapy in Tonsillitis

Active, enrolled Phase 3 Last updated 21 May 2025

What this trial tests

Phase 3 trial testing Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage. in Acute Tonsillitis in 128 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 October 2020

Primary endpoint
31 December 2025

31 December 2028

Quick facts

Lead sponsor	Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	128
Start date	2 October 2020
Primary completion	31 December 2025
Estimated completion	31 December 2028
Sites	1 location across Uzbekistan

Drugs / interventions tested

• Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage. — full drug profile →

Conditions studied

• Acute Tonsillitis — all drugs for Acute Tonsillitis →

Sponsor

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

Who can join

Adults 3 to 14, any sex, with Acute Tonsillitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regulations of phage therapy across the world.
   Yang Q, Le S, Zhu T, Wu N. · · 2023 · cited 86× · PMID 37869667 · DOI 10.3389/fmicb.2023.1250848
2. Phage Therapy for Multi-Drug Resistant Respiratory Tract Infections.
   Iszatt JJ, Larcombe AN, Chan HK, Stick SM, et al · · 2021 · cited 30× · PMID 34578390 · DOI 10.3390/v13091809
3. Essential Topics for the Regulatory Consideration of Phages as Clinically Valuable Therapeutic Agents: A Perspective from Spain.
   Vázquez R, Díez-Martínez R, Domingo-Calap P, García P, et al · · 2022 · cited 28× · PMID 35456768 · DOI 10.3390/microorganisms10040717
4. Current Status of Phage Therapy against Infectious Diseases and Potential Application beyond Infectious Diseases.
   Xu HM, Xu WM, Zhang L. · · 2022 · cited 15× · PMID 36263241 · DOI 10.1155/2022/4913146
5. Emerging antimicrobial therapies for Gram-negative infections in human clinical use.
   Hickson SM, Ledger EL, Wells TJ. · · 2025 · cited 11× · PMID 40016340 · DOI 10.1038/s44259-025-00087-2
6. Phage and Endolysin Therapy Against Antibiotics Resistant Bacteria: From Bench to Bedside.
   Taati Moghadam M, Mohebi S, Sheikhi R, Hasannejad-Bibalan M, et al · · 2025 · cited 4× · PMID 40661138 · DOI 10.1002/mco2.70280
7. Phage therapeutic delivery methods and clinical trials for combating clinically relevant pathogens.
   Selim HMRM, Gomaa FAM, Alshahrani MY, Morgan RN, et al · · 2025 · cited 3× · PMID 39545771 · DOI 10.1080/20415990.2024.2426824
8. Efficacy of Bacteriophages in Wound Healing: An Updated Review.
   Narayanan MP, Kumar A, Kumar Verma G, Bairwa A, et al · · 2024 · cited 2× · PMID 39544596 · DOI 10.7759/cureus.71542