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

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ClinicalTrials.gov Identifier: NCT02117986
Recruitment Status : Recruiting
First Posted : April 21, 2014
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Information provided by (Responsible Party):
Hospital Barros Luco Trudeau

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.

Condition or disease Intervention/treatment Phase
Gram Negative Bacterial Infections Drug: colistin Phase 4

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
Study Start Date : April 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percentage of patients with clinical response to treatment [ Time Frame: up to 1 week ]
    remission or reduction of clinical signs of infection

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117986


Contacts
Contact: Loreto Rojas, MD 56-9-68479281 rojasloreto@gmail.com
Contact: Ruth Rosales, PharmD 56-9-95093184 ruth.rosales@vtr.net

Locations
Chile
Hospital Barros Luco Trudeau Recruiting
Santiago, Region Metropolitana, Chile, 8900085
Contact: Loreto Rojas, MD    56-9-68479281    rojasloreto@gmail.com   
Contact: Ruth Rosales, PharmD    56-9-9093184    ruth.rosales@vtr.net   
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         
Hospital de Puerto Montt Recruiting
Puerto Montt, Chile, 5507798
Contact: Loreto Rojas, PhD    +56968479281    rojasloreto@gmail.com   
Contact: Susana Hernandez, Pharm    +56976373749    shernandez@ssdr.gob.cl   
Sponsors and Collaborators
Hospital Barros Luco Trudeau
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Investigators
Principal Investigator: Loreto Rojas, MD, PhD Hospital Barros Luco Trudeau

Responsible Party: Hospital Barros Luco Trudeau
ClinicalTrials.gov Identifier: NCT02117986     History of Changes
Other Study ID Numbers: SA13I20317
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Hospital Barros Luco Trudeau:
critically ill patients
colistin dosing
multidrug resistant bacteria

Additional relevant MeSH terms:
Bacterial Infections
Gram-Negative Bacterial Infections
Colistin
Anti-Bacterial Agents
Anti-Infective Agents