NCT05689229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 13, 2023

Last Update Submit

January 13, 2023

Conditions

Secondary Bacterial Infection in COVID-19 Patients

Outcome Measures

Primary Outcomes (2)

  • Microbial eradication

    10 days

  • Mortality

    30 days

Secondary Outcomes (1)

  • Nephrotoxicity

    10 days

Study Arms (3)

Colistin IV

ACTIVE COMPARATOR
Drug: Colistin

Colistin Aerosolized

ACTIVE COMPARATOR
Drug: Colistin

Control

NO INTERVENTION

Interventions

ColistinDRUG

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

Colistin AerosolizedColistin IV

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Banī Suwayf, Beni Suweif Governorate, 13556, Egypt

Location

MeSH Terms

Interventions

Colistin

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 19, 2023

Study Start

August 3, 2021

Primary Completion

November 28, 2021

Study Completion

December 12, 2021

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

EG(1)