Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients

March 12, 2018 updated by: Hospital Barros Luco Trudeau

Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
      • Puerto Montt, Chile, 5507798
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8900085
        • Recruiting
        • Hospital Barros Luco Trudeau
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ruth Rosales, PharmD
        • Sub-Investigator:
          • Alexis Castro, PharmD
        • Sub-Investigator:
          • Ronald Pauramani, MD
        • Principal Investigator:
          • Loreto Rojas, MD, PhD
        • Sub-Investigator:
          • Jorge Silva, MD
        • Sub-Investigator:
          • Sheyla Jimenez, MD
        • Sub-Investigator:
          • Sofía Palma, MD
        • Sub-Investigator:
          • Carlos Beltrán, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: loading dose of colistin
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
Drug: colistin
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.
Other Names:
  • colistimethate sodium
  • polymyxin e
ACTIVE_COMPARATOR: without loading dose of colistin
Patients will receive 3 million international units of colistin every 8 hours intravenous
Drug: colistin
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.
Other Names:
  • colistimethate sodium
  • polymyxin e

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with clinical response to treatment
Time Frame: up to 1 week
remission or reduction of clinical signs of infection
up to 1 week
percentage of patients with microbiological response
Time Frame: up to 1 week
negative culture at the same site where the positive culture was obtained before
up to 1 week
mortality
Time Frame: during their stay in the intensive care unit
the mortality during their stay in the intensive care unit, an expected average of 4 weeks
during their stay in the intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Barros Luco Trudeau

Collaborators

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Investigators

  • Principal Investigator: Loreto Rojas, MD, PhD, Hospital Barros Luco Trudeau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (ESTIMATE)

April 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA13I20317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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