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

NCT01915082 | Completed Phase 4

• 2 other identifiers: AZI0032012-003331-32
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disorder Related to Lung Transplantation

Keywords

Lung Function; Allograft Outcome

Outcome Measures

Primary Outcomes (1)

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

  Mean FEV1 (%pred) during the first 3 months after lung transplantation (measured at discharge; thereafter twice weekly until 8 weeks post-transplant and weekly from 8 to 12 weeks post-transplant; i.e. total estimated number of 14 spirometries per patient)

  at 3 months after lung transplantation

Secondary Outcomes (13)

• Length of intubation

  at 1 month after lung transplantation

• Length of Intensive Care Unit (ICU) stay

  at 3 months after lung transplantation

• Length of hospital stay

  at 3 months after lung transplantation

• Partial Pressure of Oxygen in Arterial Blood over fraction of inspired oxygen fraction - ratio (PaO2/FiO2)

  at 0, 24, 48 and 72 hours after lung transplantation

• Primary graft dysfunction (PGD) prevalence and score

  at 0, 24, 48 and 72 hours after lung transplantation

Other Outcomes (2)

• Chronic lung allograft dysfunction

  at 1 and 2 years after lung transplantation

• Intra-operative respiratory and hemodynamic parameters

  at day 1 after lung transplantation

Study Arms (2)

Azithromycin

EXPERIMENTAL

A first dose of azithromycin (25 mL po syrup = 1000 mg) will be given during preparation for subsequent lung transplantation (Day 0). After lung transplantation, 'add on' treatment of azithromycin (6.25 mL = 250 mg) syrup will be given via (naso)gastric tube or per os every other day (days 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29 and 31).

Drug: Azithromycin

Ora-Plus

PLACEBO COMPARATOR

A first dose of placebo (25 mL po syrup) will be given during preparation for subsequent lung transplantation (Day 0). After lung transplantation, 'add on' treatment of placebo (6.25 mL) syrup will be given via (naso)gastric tube or per os every other day (days 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29 and 31).

Drug: Ora-Plus

Interventions

Azithromycin DRUG

Zithromax® oral suspension 200 mg/ 5 mL (Pfizer, UK): Zithromax® 1000 mg syrup per os once at recipient intake for lung transplantation (day 0); followed by Zithromax® 250 mg syrup via (naso)gastric tube or per os every other day until one month after lung transplantation (days 1,3,5,7,9,11,13,15, 17,19,21,23,25,27,29 and 31).

Also known as: Zithromax®

Azithromycin

Ora-Plus DRUG

Ora-Plus® oral suspension (Paddock Laboratories, 3940 Quebec Avenue N, Minneapolis, MN 55427, USA; NDC-number: 0574-0303-16): Ora-Plus® 25mL syrup per os once at recipient intake for lung transplantation (day 0); followed by Ora-Plus® 6.25 mL syrup via (naso)gastric tube or per os every other day until one month after lung transplantation (days 1,3,5,7,9,11,13,15, 17,19,21,23,25,27,29 and 31).

Also known as: Ora-Plus®

Ora-Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator
• KU Leuven: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

• Van Herck A, Frick AE, Schaevers V, Vranckx A, Verbeken EK, Vanaudenaerde BM, Sacreas A, Heigl T, Neyrinck AP, Van Raemdonck D, Dupont LJ, Yserbyt J, Verleden SE, Verleden GM, Vos R. Azithromycin and early allograft function after lung transplantation: A randomized, controlled trial. J Heart Lung Transplant. 2019 Mar;38(3):252-259. doi: 10.1016/j.healun.2018.12.006. Epub 2018 Dec 14.

  PMID: 30686699 DERIVED

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Robin Vos, MD, PhD

  UZ and KULeuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: August 2, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2015
• Last Updated: November 11, 2015

Record last verified: 2013-09

Locations

BE (1)