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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02117986

Enrollment

200

Registered

2014-04-21

Start date

2014-04-30

Completion date

2018-12-31

Last updated

2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram Negative Bacterial Infections

Keywords

critically ill patients, colistin dosing, multidrug resistant bacteria

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.

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.

Interventions

DRUGcolistin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients with clinical response to treatment	up to 1 week	remission or reduction of clinical signs of infection
percentage of patients with microbiological response	up to 1 week	negative culture at the same site where the positive culture was obtained before
mortality	during their stay in the intensive care unit	the mortality during their stay in the intensive care unit, an expected average of 4 weeks

Countries

Chile

Contacts

Primary ContactLoreto Rojas, MD

rojasloreto@gmail.com56-9-68479281

Backup ContactRuth Rosales, PharmD

ruth.rosales@vtr.net56-9-95093184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026