Trial record 5 of 73 for:    Open Studies | "lung transplantation"

Peri-operative Azithromycin to Improve Early Allograft Function and Outcome After Lung Transplantation (AZI003)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01915082
First received: July 4, 2013
Last updated: October 1, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Disorder Related to Lung Transplantation
Drug: Azithromycin
Drug: Ora-Plus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Placebo-controlled Trial of Pre-transplant and Prompt Post-transplant Treatment With Azithromycin to Improve Early Allograft Function and Outcome After Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Mean forced expiratory volume at one second (FEV1, %pred) [ Time Frame: at 3 months after lung transplantation ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Length of intubation [ Time Frame: at 1 month after lung transplantation ] [ Designated as safety issue: No ]
  • Length of Intensive Care Unit (ICU) stay [ Time Frame: at 3 months after lung transplantation ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: at 3 months after lung transplantation ] [ Designated as safety issue: No ]
  • Partial Pressure of Oxygen in Arterial Blood over fraction of inspired oxygen fraction - ratio (PaO2/FiO2) [ Time Frame: at 0, 24, 48 and 72 hours after lung transplantation ] [ Designated as safety issue: No ]
  • Primary graft dysfunction (PGD) prevalence and score [ Time Frame: at 0, 24, 48 and 72 hours after lung transplantation ] [ Designated as safety issue: No ]
  • 6-minute walking distance [ Time Frame: at 1 month after lung transplantation ] [ Designated as safety issue: No ]
  • Acute rejection (grade A; grade B) prevalence/severity [ Time Frame: at 1, 3 and 6 months after lung transplantation ] [ Designated as safety issue: No ]
  • Broncho-alveolar lavage neutrophilia and cytokine/protein profile [ Time Frame: at day 1 and at 1, 3 and 6 months after lung transplantation ] [ Designated as safety issue: No ]
  • Airway colonization [ Time Frame: at day 1 and 1, 3 and 6 months after lung transplantation ] [ Designated as safety issue: No ]
    Presence (i.e. growth) of Pseudomonas species or Aspergillus species in routine cultures of broncho-alveolar lavage fluid at day 1 and 1, 3 and 6 months after lung transplantation.

  • Plasma C-reactive protein levels [ Time Frame: at day 1, 3, 5, 7, 14 and 1, 3 and 6 months after lung transplantation ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: at 1, 3 and 6 months after lung transplantation ] [ Designated as safety issue: No ]
  • Ventilator-free days [ Time Frame: at 6 months after transplantation ] [ Designated as safety issue: No ]
    days alive and free from mechanical ventilation

  • Mean forced expiratory volume at one second (FEV1, %pred) [ Time Frame: at 6 months after lung transplantation ] [ Designated as safety issue: No ]
    Mean FEV1 (%pred) during the first 6 months after lung transplantation


Other Outcome Measures:
  • Chronic lung allograft dysfunction [ Time Frame: at 1 and 2 years after lung transplantation ] [ Designated as safety issue: No ]
  • Intra-operative respiratory and hemodynamic parameters [ Time Frame: at day 1 after lung transplantation ] [ Designated as safety issue: No ]
    Intra-operative respiratory parameters (vent. mode (PCV/VCV), Pinsp (PCV), Tidal Volume (VCV/PCV), Ppeak (VCV), Pplat (VCV), Pmean (VCV), PEEP, I:E ratio, One Lung Ventilation (Y/N), Bilateral Lung Ventilation, FiO2, PaO2, PaCO2, End-Tidal CO2, MVSO2) and hemodynamic parameters (PAP (S/D/Mean), BP (S/D/Mean), CO, Heart Rate, CVD) and use of Cardio Pulmonary Bypass or Extra Corporeal Membrane Oxygenation at T0 (after induction) and after 1, 2, 3, 4, 5, 6, 7, 8, etc. hours during transplantation and at the end of operation.


Estimated Enrollment: 70
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin

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

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).

Other Name: Zithromax®
Placebo Comparator: Ora-Plus

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

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).

Other Name: Ora-Plus®

Detailed Description:

After a lung transplant recipient is put on the waiting list for subsequent lung transplantation, informed consent will be sought for the current study. If signed informed is obtained, the patient will be enrolled upon admission for transplantation at which moment he/she will be randomised to placebo or azithromycin according to a blinded randomisation-list. In accordance with his/her attributed study-number, each included patient will be assigned to a pre-numbered bottle containing the study-drug, which was pre-filled and blinded for its content and are delivered in advance to the ward by the University Leuven Hospital Pharmacy. From this bottle, a first loading dose of placebo (25 mL po syrup) or azithromycin (25 mL po syrup = 1000 mg) will be given by the nurse during preparation for subsequent lung transplantation (Day 0). After lung transplantation, 'add on' treatment of placebo (6.25 mL) or 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) by the nurses taking care of the patient in the early post-transplant period. In case of any serious suspected drug-interactions (however very unlikely) or adverse attributable to the study drug, the study will be promptly stopped in this patient. Serious adverse events will be monitored by the treating lung transplant physicians (blinded for the study-drug) and are defined as allergic reactions including skin reactions (rash, urticaria or Stevens-Johnson syndrome), angioneurotic edema and anaphylaxis, cardiac arrhythmias (ventricular tachycardia or torsades de pointes), neurologic disorders (convulsions). Routine immunosuppressive, prophylactic and necessary antimicrobial treatment according to standardized protocol is given to all patients, independent of study drug. After transplantation, routine follow-up (e.g. biochemical and microbiological blood analyses, chest radiography, pulmonary function testing and bronchoscopic evaluation with broncho-alveolar lavage and/or trans- or endobronchial biopsies will be performed as they are currently routinely being performed as part of the standard, prospective follow-up after lung transplantation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915082

Contacts
Contact: Robin Vos, MD, PhD +32 16 34 15 48 robin.vos@uzleuven.be
Contact: Geert M Verleden, MD, PhD +32 16 34 68 08 geert.verleden@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, B-3000
Contact: Robin Vos, MD, PhD    +32 16 34 15 48    robin.vos@uzleuven.be   
Contact: Geert M Verleden, MD, PhD    +32 16 34 68 08    geert.verleden@uzleuven.be   
Principal Investigator: Robin Vos, MD, PhD         
Sub-Investigator: Geert M Verleden, MD, PhD         
Sub-Investigator: Bart M Vanaudenaerde, MsC, PhD         
Sub-Investigator: Stijn E Verleden, MsC, PhD         
Sub-Investigator: David Ruttens, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Robin Vos, MD, PhD UZ and KULeuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01915082     History of Changes
Other Study ID Numbers: AZI003, 2012-003331-32
Study First Received: July 4, 2013
Last Updated: October 1, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
Lung Function
Allograft Outcome

Additional relevant MeSH terms:
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014