Aerosolized Versus Intravenous Colistin-based Antimicrobial Regimens in Hospitalized COVID-19 Patients With Bacterial Coinfection: A Randomized Controlled Trial

Phase 3

Completed

• Conditions: Secondary Bacterial Infection in COVID-19 Patients
• Interventions: Drug: Colistin

• Registration Number: NCT05689229
• Lead Sponsor: Beni-Suef University

Brief Summary

Secondary bacterial pathogen infection has been demonstrated to aggravate COVID-19 clinical outcomes. Bacterial infections acquired during a hospital stay are likely resistant to several antimicrobial medicines, making COVID-19 patient management difficult. As a result, it is believed that aerosolized colistin might be a viable choice for treating secondary bacterial infections caused by gram-negative resistant strains in individuals who also have COVID-19 infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-03
• Primary Completion: 2021-11-28
• Study Completion: 2021-12-12
• Status Verified: 2023-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-13
• Last Update Submitted: 2023-01-13
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Covid-19 patients with secondary gram-negative bacterial infections

Exclusion Criteria

• Patients with resistant bacterial strains to polymyxins
• patients less than 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colistin IV	Colistin	-
Colistin Aerosolized	Colistin	-

Primary Outcome Measures

Name	Time	Method
Microbial eradication	10 days
Mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Nephrotoxicity	10 days

Trial Locations

Locations (1)

University Hospital; 🇪🇬 Banī Suwayf, Beni-Suef, Egypt