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

NCT02117986 | Unknown Phase 4 DMC

• 1 other identifier: SA13I20317
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Gram Negative Bacterial Infections

Keywords

critically ill patients; colistin dosing; multidrug resistant bacteria

Outcome Measures

Primary Outcomes (3)

• Percentage of patients with clinical response to treatment

  remission or reduction of clinical signs of infection

  up to 1 week

• percentage of patients with microbiological response

  negative culture at the same site where the positive culture was obtained before

  up to 1 week

• mortality

  the mortality during their stay in the intensive care unit, an expected average of 4 weeks

  during their stay in the intensive care unit

Study Arms (2)

loading dose of colistin

EXPERIMENTAL

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

without loading dose of colistin

ACTIVE COMPARATOR

Patients will receive 3 million international units of colistin every 8 hours intravenous

Drug: colistin

Interventions

colistin DRUG

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.

Also known as: colistimethate sodium, polymyxin e

loading dose of colistin; without loading dose of colistin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or breastfeeding patients
• patient with a history of hypersensitivity to colistin

Sponsors & Collaborators

• Hospital Barros Luco Trudeau: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (2)

Hospital Barros Luco Trudeau

Santiago, Santiago Metropolitan, 8900085, Chile

RECRUITING

Hospital de Puerto Montt

Port Montt, 5507798, Chile

RECRUITING

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Interventions

Colistin; colistinmethanesulfonic acid

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Officials

• Loreto Rojas, MD, PhD

  Hospital Barros Luco Trudeau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loreto Rojas, MD

CONTACT

56-9-68479281; rojasloreto@gmail.com

Ruth Rosales, PharmD

CONTACT

56-9-95093184; ruth.rosales@vtr.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

CL (2)