CompletedPhase 4

Peri-operative Azithromycin to Improve Early Allograft Function and Outcome After Lung Transplantation

Belgium70 participantsStarted 2013-09

Plain-language summary

This study investigates possible beneficial effects of peri-operative treatment (i.e. pre-transplant initiation and prompt post-transplant continuation) with azithromycin in lung transplantation. Our hypothesis is that this therapy will improve early allograft function and outcome following human lung transplantation.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Signed informed consent * Adult (age at least 18 years old at moment of transplantation) * Single lung transplantation, sequential single (double) lung transplantation or heart-lung transplantation Exclusion Criteria: * Known previous allergy for azithromycin (including skin reactions such as rash, urticaria or Stevens- Johnson syndrome, angioneurotic oedema and anaphylaxis) * Retransplantation or multi-organ (other than heart-lung) transplantation * Inclusion in Transmedics® Organ Care System (OCS™ LUNG) study (OCS-LUN-03-2010)(S53795).

What they're measuring

Mean forced expiratory volume at one second (FEV1, %pred)

Timeframe: at 3 months after lung transplantation

Trial details

NCT IDNCT01915082

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

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