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Safety and Efficacy Study of High Dose Colistin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162966
Recruitment Status : Unknown
Verified March 2015 by King Saud Medical City.
Recruitment status was:  Recruiting
First Posted : June 13, 2014
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
King Saud Medical City

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.

Condition or disease Intervention/treatment Phase
Infectious Diseases Drug: High Dose Colistin Drug: Standard Dose Colistin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial
Study Start Date : May 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Dose Colistin
High dose colistin protocol
Drug: High Dose Colistin
High Dose Colistin
Other Name: colistin

Active Comparator: Standard Dose Colistin
Standard dose of colistin
Drug: Standard Dose Colistin
Standard Dose Colistin
Other Name: Colistin




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 7 days after the end of therapy or at 28 days after enrollment ]
  2. Ventilation free days [ Time Frame: 28 days after enrollment ]
  3. Length of ICU stay [ Time Frame: 28 days after enrollment ]
  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162966


Contacts
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Contact: Ahmed F Mady, PhD 00966547060770 afmady@ksmc.med.sa
Contact: Basheer M Abdelrahman, pharmD 00966563516815

Locations
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Saudi Arabia
King Saud Medical City Recruiting
Riyadh, Saudi Arabia, 00966
Contact: Ahmed F Mady, PhD    00966547060770    afmady@ksmc.med.sa   
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         
Sponsors and Collaborators
King Saud Medical City
Investigators
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Principal Investigator: Ahmed F Mady, PhD King Saud Medical City

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Responsible Party: King Saud Medical City
ClinicalTrials.gov Identifier: NCT02162966     History of Changes
Other Study ID Numbers: KSMC-CCD-AFM-002
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by King Saud Medical City:
colistin
ICU
critical care
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Colistin
Anti-Bacterial Agents
Anti-Infective Agents