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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

rojasloreto@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ruth Rosales, PharmD

Phone

56-9-95093184

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

rojasloreto@gmail.com

First Name & Middle Initial & Last Name & Degree

Ruth Rosales, PharmD

Phone

56-9-9093184

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

rojasloreto@gmail.com

First Name & Middle Initial & Last Name & Degree

Susana Hernandez, Pharm

Phone

+56976373749

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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