Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
Primary Purpose
Gram Negative Bacterial Infections
Status
Unknown status
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
colistin
Sponsored by
About this trial
This is an interventional treatment trial for Gram Negative Bacterial Infections focused on measuring critically ill patients, colistin dosing, multidrug resistant bacteria
Eligibility Criteria
Inclusion Criteria:
- patient hospitalized in critical care units
- patient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin
- source of infection: blood, respiratory, intra abdominal or urinary
Exclusion Criteria:
- pregnant or breastfeeding patients
- patient with a history of hypersensitivity to colistin
Sites / Locations
- Hospital Barros Luco TrudeauRecruiting
- Hospital de Puerto MonttRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
loading dose of colistin
without loading dose of colistin
Arm Description
Patients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous
Patients will receive 3 million international units of colistin every 8 hours intravenous
Outcomes
Primary Outcome Measures
Percentage of patients with clinical response to treatment
remission or reduction of clinical signs of infection
percentage of patients with microbiological response
negative culture at the same site where the positive culture was obtained before
mortality
the mortality during their stay in the intensive care unit, an expected average of 4 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT02117986
First Posted
April 2, 2014
Last Updated
March 12, 2018
Sponsor
Hospital Barros Luco Trudeau
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
1. Study Identification
Unique Protocol Identification Number
NCT02117986
Brief Title
Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
Official Title
Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Barros Luco Trudeau
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose.
Detailed Description
It is a prospective, multicenter, randomized, controlled study to evaluate a scheme with and without a loading dose of 6 million international units of colistin, followed by a maintenance dose of 3 million international units every 8 hours intravenous. The study should be conducted in 3 hospitals in Chile, in critically patients presenting infection by multidrug Gram-negative bacteria and requiring be treated with colistin for at least 48 hours. The objectives of the study are: to evaluate the clinical and microbiological response, and mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram Negative Bacterial Infections
Keywords
critically ill patients, colistin dosing, multidrug resistant bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
loading dose of colistin
Arm Type
Experimental
Arm Description
Patients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous
Arm Title
without loading dose of colistin
Arm Type
Active Comparator
Arm Description
Patients will receive 3 million international units of colistin every 8 hours intravenous
Intervention Type
Drug
Intervention Name(s)
colistin
Other Intervention Name(s)
colistimethate sodium, polymyxin e
Intervention Description
One arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours.
Primary Outcome Measure Information:
Title
Percentage of patients with clinical response to treatment
Description
remission or reduction of clinical signs of infection
Time Frame
up to 1 week
Title
percentage of patients with microbiological response
Description
negative culture at the same site where the positive culture was obtained before
Time Frame
up to 1 week
Title
mortality
Description
the mortality during their stay in the intensive care unit, an expected average of 4 weeks
Time Frame
during their stay in the intensive care unit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient hospitalized in critical care units
patient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin
source of infection: blood, respiratory, intra abdominal or urinary
Exclusion Criteria:
pregnant or breastfeeding patients
patient with a history of hypersensitivity to colistin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loreto Rojas, MD
Phone
56-9-68479281
Email
rojasloreto@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Rosales, PharmD
Phone
56-9-95093184
Email
ruth.rosales@vtr.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loreto Rojas, MD, PhD
Organizational Affiliation
Hospital Barros Luco Trudeau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Barros Luco Trudeau
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8900085
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loreto Rojas, MD
Phone
56-9-68479281
Email
rojasloreto@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruth Rosales, PharmD
Phone
56-9-9093184
Email
ruth.rosales@vtr.net
First Name & Middle Initial & Last Name & Degree
Ruth Rosales, PharmD
First Name & Middle Initial & Last Name & Degree
Alexis Castro, PharmD
First Name & Middle Initial & Last Name & Degree
Ronald Pauramani, MD
First Name & Middle Initial & Last Name & Degree
Loreto Rojas, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jorge Silva, MD
First Name & Middle Initial & Last Name & Degree
Sheyla Jimenez, MD
First Name & Middle Initial & Last Name & Degree
Sofía Palma, MD
First Name & Middle Initial & Last Name & Degree
Carlos Beltrán, MD
Facility Name
Hospital de Puerto Montt
City
Puerto Montt
ZIP/Postal Code
5507798
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loreto Rojas, PhD
Phone
+56968479281
Email
rojasloreto@gmail.com
First Name & Middle Initial & Last Name & Degree
Susana Hernandez, Pharm
Phone
+56976373749
Email
shernandez@ssdr.gob.cl
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
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