Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-30 @ 6:29 PM
Study NCT ID:
NCT06907069
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-02
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polycolistin E Sodium Mesylate Combined With Intravenous Atomization for Carbapenem Resistant Gram-negative Bacteria in Pulmonary Infection
Sponsor:
First Affiliated Hospital of Ningbo University
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Open-label Clinical Study on the Treatment of Carbapenem Resistant Gram-negative Bacterial Lung Infection With Sodium Polycolistin E Mesylate Intravenically Combined With Atomization
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-03
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:
Pulmonary infection is a kind of infectious disease that seriously damages human health. It usually starts quickly and progresses rapidly in clinical manifestations, and is often accompanied by upper respiratory tract infection symptoms. With the increasing use of broad-spectrum antibiotics in clinical practice, the failure of anti-infection caused by drug-resistant bacteria is more and more common. Once a patient develops carbapenem-resistant gram-negative bacteria (CRO) infection, there are limited drug options. Therefore, HAP, as a serious and common complication, has a high incidence and mortality for ICU patients. In this study, patients who met the diagnostic criteria for pulmonary infection caused by CRO that was clearly or strongly suspected to be resistant to carbapenems but sensitive to CMS were selected, and the combined treatment regimen of CMS intravenous atomization was adopted. To explore the therapeutic effect of CMS combined with intravenous atomization in patients with carbapenem resistant gram-negative bacteria in lung infection. To evaluate the safety and tolerability of the combination regimen in patients with pulmonary infections caused by CRO. The purpose of this study was to explore the efficacy and safety of CMS combined with intravenous atomization in the treatment of patients with CRO induced pulmonary infection, and to provide a basis for its clinical rational application.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: