Clinical Trials Logo
  1. Home
  2. Pneumonia, Bacterial
  3. NCT00645723
  4. Details
NCT00645723 Clinical Trial

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

Pneumonia, Bacterial Clinical Trial

Official title:
Phase 3b Randomized Double Blind Controled Placebo Comparative Trial of Intravenous Colistin vs Intravenous Colistin Plus Nebulized Colistin in Patients With Ventilator-associated Pneumonia (VAP) Due Multiresistant Acinetobacter Baumanii

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00645723
Other study ID # COL\VAP
Secondary ID
Status Recruiting
Phase Phase 3
First received March 25, 2008
Last updated August 3, 2009
Start date April 2008
Est. completion date April 2011

Study information
Verified date August 2009
Source Hospitales Universitarios Virgen del Rocío
Contact José Garnacho, MD
Phone 34-95-501-2235
Email jose.garnacho.sspa@juntadeandalucia.es
Is FDA regulated No
Health authority European Union: European Medicines AgencySpain: Spanish Agency of MedicinesSpain: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 67
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Colistin
intravenous colistin and nebulized colistin
• Colistin and saline solution
intravenous colistin and nebulized saline solution

Locations
Country Name City State
Spain Hospital Universitario Virgen del Rocío Seville

Sponsors (1)
Lead Sponsor Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 14 days Yes
See also
  Status Clinical Trial Phase
Completed NCT03303976 - Phase I to Test a New Pneumococcal Vaccine Phase 1
Completed NCT02459158 - A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia Phase 1
Completed NCT06113432 - CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study N/A
Active, not recruiting NCT03577964 - Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
Completed NCT04540081 - Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer N/A
Completed NCT00538694 - Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Phase 3
Withdrawn NCT02218359 - Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization Phase 2
Completed NCT01189487 - The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP) Phase 3
Completed NCT00515034 - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia Phase 2
Withdrawn NCT00245453 - Outpatient Registry Trial of Respiratory Tract Infections in Adults Phase 4
Completed NCT03239665 - Vaccination Education Through Pharmacists and Senior Centers (VEPSC) N/A
Completed NCT03034642 - Modulation of Steroid Immunosuppression by Alveolar Efferocytosis N/A
Completed NCT04047719 - Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
Completed NCT02292498 - Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections N/A
Completed NCT01763008 - A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections Phase 4
Recruiting NCT05976581 - Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients N/A
Completed NCT03551210 - Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia Phase 3
Completed NCT04158804 - PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT N/A
Completed NCT00805168 - Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia Phase 3
Completed NCT02778672 - Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia N/A