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 treatmentpercentage 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
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