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Polycolistin E Sodium Mesylate Combined With Intravenous Atomization for Carbapenem Resistant Gram-negative Bacteria in Pulmonary Infection

NCT06907069 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

  • Lung Infection Bacterial

Interventions

DRUG

Intravenously atomized polycolistin E sodium mesylate

To explore the therapeutic effect of CMS combined with intravenous atomization in patients with carbapenem resistant gram-negative bacteria in lung infection.

Sponsors & Collaborators

  • First Affiliated Hospital of Ningbo University

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907069 on ClinicalTrials.gov