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Azithromycin in Bronchiolitis Obliterans Syndrome (AZI001)

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ClinicalTrials.gov Identifier: NCT01009619
Recruitment Status : Completed
First Posted : November 9, 2009
Results First Posted : August 25, 2011
Last Update Posted : October 3, 2011
Sponsor:
Collaborators:
University Hospital, Gasthuisberg
Fund for Scientific Research, Flanders, Belgium
Information provided by:
KU Leuven

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Bronchiolitis Obliterans Syndrome
Graft Rejection
Lymphocytic Bronchiolitis
Respiratory Infection
Interventions: Drug: Azithromycin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Azithromycin 250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
Placebo Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.

Participant Flow:   Overall Study
    Azithromycin   Placebo
STARTED   40   43 
COMPLETED   40   43 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azithromycin 250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
Placebo Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
Total Total of all reporting groups

Baseline Measures
   Azithromycin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   43   83 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   38   42   80 
>=65 years   2   1   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.2  (0)   50.9  (0)   51.1  (0) 
Gender 
[Units: Participants]
     
Female   23   23   46 
Male   17   20   37 
Region of Enrollment 
[Units: Participants]
     
Belgium   40   43   83 


  Outcome Measures

1.  Primary:   Prevalence of Bronchiolitis Obliterans Syndrome (BOS)   [ Time Frame: 2 years post-transplant ]

2.  Primary:   Overall Survival   [ Time Frame: 2 years post-transplant ]

3.  Secondary:   Acute Rejection Incidence Rate   [ Time Frame: 2 years post-transplant ]

4.  Secondary:   Infection Incidence Rate   [ Time Frame: 2 years post-transplant ]

5.  Secondary:   Pulmonary Function   [ Time Frame: during first two years post-transplant ]

6.  Secondary:   Broncho-alveolar (BAL) Neutrophilia   [ Time Frame: during first two years post-transplant ]

7.  Secondary:   Plasma C-reactive Protein (CRP) Levels   [ Time Frame: during the first two years post-transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Dr. GM Verleden
Organization: Katholieke Universiteit Leuven and University Hospital Leuven
phone: +32 16 34 68 08
e-mail: geert.verleden@uzleuven.be


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. GM. Verleden, KULeuven and University Hospital Leuven
ClinicalTrials.gov Identifier: NCT01009619     History of Changes
Other Study ID Numbers: AZI001
EudraCT ref. 2005-003893-46 ( Registry Identifier: ISRCTN36220396 )
First Submitted: November 6, 2009
First Posted: November 9, 2009
Results First Submitted: April 21, 2011
Results First Posted: August 25, 2011
Last Update Posted: October 3, 2011