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

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT05689229

Collaborator

(none)

128

Enrollment

Location

Arms

4.3

Actual Duration (Months)

29.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Bacterial Infection in COVID-19 Patients	Drug: Colistin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 3, 2021

Actual Primary Completion Date :

Nov 28, 2021

Actual Study Completion Date :

Dec 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Colistin IV	Drug: Colistin COVID-19 patients with secondary gram-negative bacterial infections receive colistin IV or aerosolized
Active Comparator: Colistin Aerosolized	Drug: Colistin COVID-19 patients with secondary gram-negative bacterial infections receive colistin IV or aerosolized
No Intervention: Control

Arm

Intervention/Treatment

Active Comparator: Colistin IV

Drug: Colistin

COVID-19 patients with secondary gram-negative bacterial infections receive colistin IV or aerosolized

Active Comparator: Colistin Aerosolized

Drug: Colistin

COVID-19 patients with secondary gram-negative bacterial infections receive colistin IV or aerosolized

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Microbial eradication [10 days]
Mortality [30 days]

Secondary Outcome Measures

Nephrotoxicity [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Banī Suwayf	Beni-Suef	Egypt	13556

Sponsors and Collaborators

Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hasnaa Osama, Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef University

ClinicalTrials.gov Identifier:

NCT05689229

Other Study ID Numbers:

BSU-22006

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2023