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Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00610623
Recruitment Status : Terminated (The sponsor decided to stop the study prematurely because of financial issues)
First Posted : February 8, 2008
Last Update Posted : February 8, 2008
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
Anbics Management-Services Ag

Brief Summary:
The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.

Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-Associated Pseudomonas Infections Drug: azithromycin Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa
Study Start Date : April 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005


Arm Intervention/treatment
Experimental: 1
azithromycin iv 300 mg/day
Drug: azithromycin
300 mg/day, IV from day 1 to 20
Other Name: Zithromax

Placebo Comparator: 2
Placebo
Drug: placebo
once per day, IV from day 1 to 20




Primary Outcome Measures :
  1. Occurrence of and time to Pseudomonas aeruginosa pneumonia [ Time Frame: daily ]

Secondary Outcome Measures :
  1. occurrence of and time to death [ Time Frame: daily ]
  2. time to extubation [ Time Frame: daily ]
  3. overall outcome [ Time Frame: daily ]
  4. duration of hospitalization and ICU stay [ Time Frame: daily ]
  5. occurrence of infections to other bacterial strains [ Time Frame: daily ]
  6. cost assessment [ Time Frame: daily ]
  7. demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa [ Time Frame: daily ]
  8. determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics [ Time Frame: daily ]
  9. determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin [ Time Frame: daily ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and non pregnant female aged 18 to 75 years
  • Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more
  • Reasonable survival chance within next few days with an Apache score 10-25
  • Tracheal aspirate found positive for P. aeruginosa
  • The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent
  • Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member

Exclusion Criteria:

  • Poor prognosis as judged by Apache score II score >25
  • Pregnant female
  • Grossly under-or overweight (BMI<18or >29)
  • Ongoing therapy with a macrolide
  • Known allergy to any macrolide
  • Proven P. aeruginosa pneumonia
  • Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain
  • Anticipated short duration of mechanical ventilation (<3 days)
  • Known drug interaction that could either decrease efficacy or raise safety concerns
  • Severe hepatic failure (type C, score >10 on Child Pugh scale)
  • Sick sinus syndrome or long QT syndrome
  • Recent donation of blood or participation in another clinical trial within 3 months
  • Any situation exposing the patient to higher risk or possibly confounding results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610623


Locations
Show Show 20 study locations
Sponsors and Collaborators
Anbics Management-Services Ag
Swiss National Science Foundation
Investigators
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Principal Investigator: Christian Van Delden, MD Service of Infectious Diseases, University Hospital Geneva, Switzerland
Study Chair: Jean Carlet, MD General Intensive Care Unit, Hospital Saint-Joseph, Paris, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christian van Delden, Service of Infectious Diseases, University Hospital Geneva
ClinicalTrials.gov Identifier: NCT00610623    
Other Study ID Numbers: Anb006#2001
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: January 2008
Keywords provided by Anbics Management-Services Ag:
Pseudomonas aeruginosa
Pneumonia
Ventilator-Associated
Quorum Sensing
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Pseudomonas Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Cross Infection
Infection
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents