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

Information source: Hospital Barros Luco Trudeau
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gram Negative Bacterial Infections

Intervention: colistin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital Barros Luco Trudeau

Official(s) and/or principal investigator(s):
Loreto Rojas, MD, PhD, Principal Investigator, Affiliation: Hospital Barros Luco Trudeau

Overall contact:
Loreto Rojas, MD, Phone: 56-9-68479281, Email: rojasloreto@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Percentage of patients with clinical response to treatment

percentage of patients with microbiological response

mortality

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Loreto Rojas, MD, Phone: 56-9-68479281, Email: rojasloreto@gmail.com

Hospital El Pino, Santiago, Metropolitana, Chile; Not yet recruiting
Loreto Rojas, MD, PhD, Phone: 56-9-68479281, Email: rojasloreto@gmail.com
Ruth Rosales, PharmD, Phone: 56-9-95093184, Email: ruth.rosales@vtr.net
Arie Altman, MD, Sub-Investigator
Julia Gil, MD, Sub-Investigator

Hospital Barros Luco Trudeau, Santiago, Region Metropolitana 8900085, Chile; Recruiting
Loreto Rojas, MD, Phone: 56-9-68479281, Email: rojasloreto@gmail.com
Ruth Rosales, PharmD, Phone: 56-9-9093184, Email: ruth.rosales@vtr.net
Ruth Rosales, PharmD, Sub-Investigator
Alexis Castro, PharmD, Sub-Investigator
Ronald Pauramani, MD, Sub-Investigator
Loreto Rojas, MD, PhD, Principal Investigator
Jorge Silva, MD, Sub-Investigator
Sheyla Jimenez, MD, Sub-Investigator
Sofía Palma, MD, Sub-Investigator
Carlos Beltrán, MD, Sub-Investigator

Additional Information

Starting date: April 2014
Last updated: June 2, 2015

Page last updated: August 23, 2015

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