Safety and Efficacy Study of High Dose Colistin

March 31, 2015 updated by: King Saud Medical City

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Basheer M Abdelrahman, pharmD
  • Phone Number: 00966563516815

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 00966
        • Recruiting
        • King Saud Medical City
        • Contact:
        • Principal Investigator:
          • Ahmad F Mady, PhD
        • Sub-Investigator:
          • Basheer A Abdelrahman, PharmD
        • Sub-Investigator:
          • Muhammed A Rana, MD
        • Sub-Investigator:
          • Omar A Ramadan, PhD
        • Sub-Investigator:
          • Abdulrahman M Al-Harthy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose Colistin
High dose colistin protocol
Drug: High Dose Colistin
High Dose Colistin
Other Names:
  • colistin
Active Comparator: Standard Dose Colistin
Standard dose of colistin
Drug: Standard Dose Colistin
Standard Dose Colistin
Other Names:
  • Colistin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety of high dose Colistin
Time Frame: 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.
7 to 21 days after giving Colistin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 7 days after the end of therapy or at 28 days after enrollment
7 days after the end of therapy or at 28 days after enrollment
Ventilation free days
Time Frame: 28 days after enrollment
28 days after enrollment
Length of ICU stay
Time Frame: 28 days after enrollment
28 days after enrollment
Microbiological response
Time Frame: 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
A day 7 and at the end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud Medical City

Investigators

  • Principal Investigator: Ahmed F Mady, PhD, King Saud Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSMC-CCD-AFM-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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