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

Primary Purpose

Secondary Bacterial Infection in COVID-19 Patients

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Colistin

About this trial

This is an interventional treatment trial for Secondary Bacterial Infection in COVID-19 Patients

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Colistin IV

Colistin Aerosolized

Control

Arm Description

Outcomes

Primary Outcome Measures

Microbial eradication

Mortality

Secondary Outcome Measures

Nephrotoxicity

Full Information

NCT ID

NCT05689229

First Posted

January 13, 2023

Last Updated

January 13, 2023

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT05689229

Brief Title

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

Acronym

colistin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

August 3, 2021 (Actual)

Primary Completion Date

November 28, 2021 (Actual)

Study Completion Date

December 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Bacterial Infection in COVID-19 Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colistin IV

Arm Type

Active Comparator

Arm Title

Colistin Aerosolized

Arm Type

Active Comparator

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Colistin

Intervention Description

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

Primary Outcome Measure Information:

Title

Microbial eradication

Time Frame

10 days

Title

Mortality

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Nephrotoxicity

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University Hospital

City

Banī Suwayf

State/Province

Beni-Suef

ZIP/Postal Code

13556

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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