Back to resultsSafety and Efficacy Study of High Dose Colistin
Primary Purpose
Infectious Diseases
Status
Unknown status
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
High Dose Colistin
Standard Dose Colistin
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Diseases focused on measuring colistin, ICU, critical care
Eligibility Criteria
Inclusion Criteria:
- Patient age more than or equal 18 years old.
- Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
- Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.
Exclusion Criteria:
- Patient age less than 18 years.
- Pregnant patient.
- If received Colistin treatment for less than 72 hours.
- Renal Replacement Therapy.
Sites / Locations
- King Saud Medical CityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Dose Colistin
Standard Dose Colistin
Arm Description
High dose colistin protocol
Standard dose of colistin
Outcomes
Primary Outcome Measures
Evaluate safety of high dose 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
All cause mortality
Ventilation free days
Length of ICU stay
Microbiological response
whole body cultures will be done at day 7 of treatment and at the end of therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02162966
Brief Title
Safety and Efficacy Study of High Dose Colistin
Official Title
Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Saud Medical City
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diseases
Keywords
colistin, ICU, critical care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Dose Colistin
Arm Type
Experimental
Arm Description
High dose colistin protocol
Arm Title
Standard Dose Colistin
Arm Type
Active Comparator
Arm Description
Standard dose of colistin
Intervention Type
Drug
Intervention Name(s)
High Dose Colistin
Other Intervention Name(s)
colistin
Intervention Description
High Dose Colistin
Intervention Type
Drug
Intervention Name(s)
Standard Dose Colistin
Other Intervention Name(s)
Colistin
Intervention Description
Standard Dose Colistin
Primary Outcome Measure Information:
Title
Evaluate safety of high dose Colistin
Description
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.
Time Frame
7 to 21 days after giving Colistin
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
7 days after the end of therapy or at 28 days after enrollment
Title
Ventilation free days
Time Frame
28 days after enrollment
Title
Length of ICU stay
Time Frame
28 days after enrollment
Title
Microbiological response
Description
whole body cultures will be done at day 7 of treatment and at the end of therapy
Time Frame
A day 7 and at the end of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient age more than or equal 18 years old.
Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.
Exclusion Criteria:
Patient age less than 18 years.
Pregnant patient.
If received Colistin treatment for less than 72 hours.
Renal Replacement Therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed F Mady, PhD
Phone
00966547060770
Email
afmady@ksmc.med.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Basheer M Abdelrahman, pharmD
Phone
00966563516815
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed F Mady, PhD
Organizational Affiliation
King Saud Medical City
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud Medical City
City
Riyadh
ZIP/Postal Code
00966
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed F Mady, PhD
Phone
00966547060770
Email
afmady@ksmc.med.sa
First Name & Middle Initial & Last Name & Degree
Ahmad F Mady, PhD
First Name & Middle Initial & Last Name & Degree
Basheer A Abdelrahman, PharmD
First Name & Middle Initial & Last Name & Degree
Muhammed A Rana, MD
First Name & Middle Initial & Last Name & Degree
Omar A Ramadan, PhD
First Name & Middle Initial & Last Name & Degree
Abdulrahman M Al-Harthy, MD
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of High Dose Colistin
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