Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

First Affiliated Hospital of Ningbo University

Conditions:

Lung Infection Bacterial

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

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 ...

Eligibility Criteria

Inclusion

  • Voluntarily participate in the study and sign the informed consent;
  • Inpatients aged 18-80 years old, regardless of gender;
  • Patients who met the diagnostic criteria for pulmonary infection in the Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia for Adults in China (2018 Edition);
  • Infections caused by Gram-negative bacteria (CRO) that are known or strongly suspected to be resistant to carbapenems but sensitive to CMS.

Exclusion

  • Age \> 80 years old;
  • The patient had a history of severe allergy or hypersensitivity to polymyxins;
  • Patients with serious dysfunction of heart, liver, kidney and other important organs;
  • Patients with serious diseases such as malignant tumors and blood system diseases;
  • Patients with low immune function and risk of opportunistic pathogen infection;
  • Patients who used excessive colistin intravenous or atomized inhalation therapy within 72h before enrollment;
  • Have participated in other clinical trials within three months;
  • Pregnant or breastfeeding women;
  • There are other circumstances that the researcher believes are not suitable for inclusion.

Key Trial Info

Start Date :

January 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06907069

Start Date

January 1 2025

End Date

December 31 2025

Last Update

April 2 2025

Active Locations (1)

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1

The First Affiliated Hospital of Ningbo University

Ningbo, Z, China, 315040