Safety and Efficacy Study of High Dose Colistin

Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02162966

Enrollment

330

Registered

2014-06-13

Start date

2014-05-31

Completion date

2016-10-31

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Diseases

Keywords

colistin, ICU, critical care

Brief summary

Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.

Interventions

DRUGHigh Dose Colistin

High Dose Colistin

DRUGStandard Dose Colistin

Standard Dose Colistin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Inclusion Criteria: 1. Patient age more than or equal 18 years old. 2. Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism. 3. Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy. *

Exclusion criteria

1. Patient age less than 18 years. 2. Pregnant patient. 3. If received Colistin treatment for less than 72 hours. 4. Renal Replacement Therapy.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate safety of high dose Colistin	7 to 21 days after giving Colistin	Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients. The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin.

Secondary

Measure	Time frame	Description
All cause mortality	7 days after the end of therapy or at 28 days after enrollment	—
Ventilation free days	28 days after enrollment	—
Length of ICU stay	28 days after enrollment	—
Microbiological response	A day 7 and at the end of therapy	whole body cultures will be done at day 7 of treatment and at the end of therapy

Countries

Saudi Arabia

Contacts

Primary ContactAhmed F Mady, PhD

afmady@ksmc.med.sa00966547060770

Backup ContactBasheer M Abdelrahman, pharmD

00966563516815

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026