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Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia — RECOVER  

Pneumonia, Ventilator-Associated Clinical Trial

Official title:
A Randomized, Parallel, Open-Label, Phase 1/2a Study to Assess the Safety and Tolerability of Multiple Doses of the Bacteriophage Cocktail TP-122 (Component TP-122A), for the Treatment of Ventilator-Associated Pneumonia

Clinical Trial Summary

Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone.

Clinical Trial Description

This is a randomized, parallel, open label, Phase 1/2a study, to assess the safety and tolerability of multiple doses of the component A of the bacteriophage cocktail TP-122 (TP-122A) administered by nebulization in addition to SoC, compared to SoC alone, in adult subjects with VAP. SoC being defined as the treatment dispensed in ICU by the medical team in their usual manner, which will include antibiotic treatment according to current guidelines. Enrolled subjects randomized to TP-122A arm will receive 5 ml of IP by nebulization, every 8 hours, during 7 days, and will be followed-up for 28 days after the last IP administration. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . B This study will exclusively focus on assessing the safety and effectiveness of component A, TP-122A, specifically targeting infections caused by P. aeruginosa. The IP, TP-122A, will be administered by nebulization at 1x1010 Plaque Forming Units (PFU)/ml every 8h during 7 days, in addition to SoC, for the treatment of adult subjects with VAP due to P. aeruginosa. The decision to go for a frequency of administration of every 8 hours was firstly based on preclinical studies. TP-122A is composed of three lytic bacteriophages targeting P. aeruginosa. An estimated total of 15 evaluable subjects are expected to complete the study. "Evaluable patients" will be considered subjects that have received at least a total of 9 IP administrations for three consecutive days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06370598
Study type Interventional
Source Technophage, SA
Contact Margarida Barreto, Msc
Phone +351215943993
Email mbarreto@technophage.pt
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 2024
Completion date June 2025
View Details
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