Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370598
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-10
Brief Title:
Phase 12a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia
Sponsor:
Technophage SA
Organization:
Technophage SA
Study Overview
Official Title:
A Randomized Parallel Open-Label Phase 12a 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVER
Brief 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 32 ratio with 9 subjects receiving TP-122A in addition to SoC and 6 subjects receiving the SoC alone
Detailed Description:
This is a randomized parallel open label Phase 12a 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 PFUml 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
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 PFUml 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None