Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-20 @ 4:39 PM
Study NCT ID:
NCT07202234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
The purpose of this study is to systematically evaluate the efficacy and safety of bacteriophage cocktail therapy in patients with ventilator-associated pneumonia caused by Gram-negative bacterial infections.
Detailed Description:
This study investigates the clinical application of bacteriophage therapy in severe infections through a prospective, randomized, multi-center trial targeting ventilator-associated pneumonia (VAP) caused by multidrug-resistant Gram-negative bacteria. The trial will comprehensively assess the efficacy, safety, and applicability of inhaled bacteriophage cocktail therapy, providing high-quality clinical evidence to support the establishment of an evidence-based framework for phage therapy. The primary endpoint is clinical response rate, with secondary endpoints including bacterial clearance and 28-day mortality, aiming to determine the therapeutic potential and clinical value of phage cocktails in VAP treatment.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: