AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003893-46-BE

Enrollment

Registered

2009-10-21

Start date

2009-11-03

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: - 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 ;Primary end point(s): - Prevalence of chronic rejection at 1 and 2 year post-transplant - Overall survival at 1 and 2 year post-transplant	—

Measure

Time frame

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

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Countries

Belgium

Outcome results