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OpenTrials
Completed

NCT Number: NCT05689229

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital

Banī Suwayf, Beni Suweif Governorate, 13556, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colistin

Drug

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

Primary outcomes

  1. Microbial eradication

    Time frame: 10 days

  2. Mortality

    Time frame: 30 days

Secondary outcomes

  1. Nephrotoxicity

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Acronym: colistin

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2023
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.