ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	30 March 2021
Main ID:	EUCTR2005-003893-46-BE
Date of registration:	21/10/2009
Prospective Registration:	Yes
Primary sponsor:	KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)
Public title:	AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001
Scientific title:	AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001
Date of first enrolment:	03/11/2009
Target sample size:	80
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003893-46
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: In case of chronic rejection/BOS, study drug (azi or plac) is shifted to active azithromycin If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
Belgium

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
- Stable LTx recipients at discharge after transplantation.
- Signed informed consent
- Adult (age at least 18 years old at moment of transplantation)
- Able to take oral medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Prolonged and/or complicated ICU-course after transplantation.
- Early (<30 days post-transplant) post-operative death
- Major suture problems (airway stenosis or stent)
- Retransplantation (lung)
- Previous transplantation (solid organ)
- Multi-organ transplantation (lung+ other solid organ)

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

- Chronic rejection at 1 and 2 year post-lung transplantation - Mortality at 1 and 2 year post-lung transplantation - Acute rejection rate at 1 and 2 post-lung transplantation - Infection rate at 1 and 2 year post-lung transplantation - Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation
MedDRA version: 12.0 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis
MedDRA version: 12.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
MedDRA version: 12.0 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis
MedDRA version: 12.0 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10025127 Term: Lung transplant
MedDRA version: 12.0 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10051604 Term: Lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10056409 Term: Heart and lung transplant
MedDRA version: 12.0 Level: LLT Classification code 10016547 Term: FEV
MedDRA version: 12.0 Level: LLT Classification code 10016549 Term: FEV 1 abnormal
MedDRA version: 12.0 Level: LLT Classification code 10016550 Term: FEV 1 decreased
MedDRA version: 12.0 Level: LLT Classification code 10016553 Term: FEV 1 low

Intervention(s)

Trade Name: Zithromax
Product Name: Zithromax
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
CAS Number: 117772700
Current Sponsor code: ZTM 250
Other descriptive name: AZITHROMYCIN DIHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: - Prevalence of chronic rejection at 1 and 2 year post-transplant
- Overall survival at 1 and 2 year post-transplant

Primary end point(s): - Prevalence of chronic rejection at 1 and 2 year post-transplant
- Overall survival at 1 and 2 year post-transplant

Secondary Objective: - Acute rejection rate at 1 and 2 year post-transplant
- Infection rate at 1 and 2 year post-transplant
- Evolution of pulmonary function (FEV1 and FEF25-75) during the first and second year after transplantation
- Evolution of BAL cellularity, protein levels (e.g. IL-8, IL-17) and microbiology (e.g.
Chlamydia, Mycoplasma, Pseudomonas species or other bacterial or viral colonisations) during the first and second year after transplantation

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 06/07/2005
Contact:

Results

Results available:	Yes
Date Posted:	02/01/2021
Date Completed:	28/12/2010
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003893-46/results

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.