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
1 other identifier
interventional
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedApril 1, 2015
March 1, 2015
2.4 years
May 21, 2014
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7 to 21 days after giving Colistin
Secondary Outcomes (4)
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
Study Arms (2)
High Dose Colistin
EXPERIMENTALHigh dose colistin protocol
Standard Dose Colistin
ACTIVE COMPARATORStandard dose of colistin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient age less than 18 years.
- Pregnant patient.
- If received Colistin treatment for less than 72 hours.
- Renal Replacement Therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Saud Medical City
Riyadh, Riyadh Region, 00966, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed F Mady, PhD
King Saud Medical City
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
June 13, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
April 1, 2015
Record last verified: 2015-03