Viewing Study NCT04633317



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Last Modification Date: 2024-10-26 @ 1:49 PM
Study NCT ID: NCT04633317
Status: COMPLETED
Last Update Posted: 2023-06-02
First Post: 2020-11-14

Brief Title: Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia
Sponsor: Chang Gung University
Organization: Chang Gung University

Study Overview

Official Title: Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia
Status: COMPLETED
Status Verified Date: 2023-05
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: CRGNB
Brief Summary: The purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia We hypothesize that adjunct aerosolized colistin which achieve high drug concentrations in the airway would more effectively treat the penumbra
Detailed Description: To treat respiratory infection of patients with mechanical ventilation greater systemic antibiotic dose is required through the patients venous injection In this trial patients with arbapenem-resistant gram negative bacteria pneumonia CRGNBwere assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol

Need for a systemic antibiotic was determined by the clinical physician Comparisons were made between standard care and study drug for their effects on bacteria eradiation incidence of nephrotoxicity and oxygenation

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?: None