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

Gram Negative Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02117986
• Other study ID #: SA13I20317
• Status: Recruiting
• Phase: Phase 4
• First received: April 2, 2014
• Last updated: March 12, 2018
• Start date: April 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Hospital Barros Luco Trudeau
• Contact: Loreto Rojas, MD
• Phone: 56-9-68479281
• Email: rojasloreto[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Gram Negative Bacterial Infections
• Gram-Negative Bacterial Infections

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital de Puerto Montt	Puerto Montt
Chile	Hospital Barros Luco Trudeau	Santiago	Region Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Barros Luco Trudeau	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with clinical response to treatment	remission or reduction of clinical signs of infection	up to 1 week
Primary	percentage of patients with microbiological response	negative culture at the same site where the positive culture was obtained before	up to 1 week
Primary	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