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Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii

H

Hospitales Universitarios Virgen del Rocío

Status and phase

Unknown
Phase 3

Conditions

Cross Infection
Pneumonia, Bacterial

Treatments

Drug: Colistin and saline solution
Drug: Colistin

Study type

Interventional

Funder types

Other

Identifiers

NCT00645723
COL\VAP

Details and patient eligibility

About

Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Full description

Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Enrollment

67 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnose of VAP due A. baumannii or A. baumannii and another microorganism carbapenems resistant.
  • Clinical Pulmonary Infection Score (CPIS) > 6

Exclusion criteria

  • Allergy to colistin.
  • Asthma
  • Shock status
  • Diagnose of VAP due A. baumannii colistin resistant.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

67 participants in 2 patient groups, including a placebo group

A
Experimental group
Description:
Intravenous colistin and nebulized colistin
Treatment:
Drug: Colistin
B
Placebo Comparator group
Description:
intravenous colistin and saline solution nebulized
Treatment:
Drug: Colistin and saline solution

Trial contacts and locations

1

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Central trial contact

José Garnacho, MD

Data sourced from clinicaltrials.gov

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