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

NCT ID: NCT05689229

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2021-12-12

Brief Summary

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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

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Conditions

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Secondary Bacterial Infection in COVID-19 Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colistin IV

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

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

Colistin Aerosolized

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colistin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Hasnaa Osama

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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BSU-22006

Identifier Type: -

Identifier Source: org_study_id

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