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Lung Transplant RecipientPhase 2NCT01254708

Safety and Efficacy Study of Inhaled AmBisome for Prevention of Aspergillus Colonization in Lung Transplant Recipients

A Phase 2 study testing Ambisome ® in people with Lung Transplant Recipient, run by University Health Network, Toronto at 1 site in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among solid organ transplant recipients. The most important risk factor for the development of IA (which is associated with disease and death) is colonization of the organism in the respiratory tract. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplant Recipient
What is being tested?
Ambisome ®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteCanada
Study dates
Jan 2012to Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Single or double lung transplant recipients who are at least one year out of transplantation.
  • Age >18yrs of age
  • Able to understand and complete informed consent.

Who cannot join

  • Pregnant woman or woman capable of bearing children, who will not perform urine pregnancy test.
  • Nursing mothers.
  • Subjects with hypersensitivity to Amphotericin deoxycholate or liposomal Amphotericin.
  • Subjects with a past history of bronchospasm associated with aerosol drug use.
  • Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications.
  • Subjects treated with cytolytic medications (Campath /Thymoglobulin) within the last month.
Show all 18Show fewer
  • Subjects with an FEV1< 30% Predicted or FVC% <30%.
  • Subjects requiring supplemental oxygen.
  • Receipt of Inhaled or IV Amphotericin B within last 30 days.
  • Subjects with known fungal infection as per MSG Criteria on therapy with antifungal drugs or diagnosed on the day of bronchoscopy.
  • Current use of azoles active against molds (Voriconazole, itraconazole, posaconazole) for the prophylaxis.
  • Serum creatinine > 150 mmol/L on the day of clinic visit.
  • Liver enzymes ALT/ AST/ Alkphos greater than two times upper limit of normal.
  • Concurrent intravenous aminoglycoside use.
  • Subjects with fever > 38.2°C.
  • Subjects on mechanical ventilation.
  • Expected survival less than 6 months.
  • Re-transplants and heart/lung transplant patients.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network/ Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

Official title: A Pilot Study to Determine the Safety and Clinical Efficacy of Once-Weekly Inhaled AmBisome for the Prevention of Aspergillus Colonization in Lung Transplant Recipients

Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among solid organ transplant recipients. The most important risk factor for the development of IA (which is associated with disease and death) is colonization of the organism in the respiratory tract.

Azoles are used to prevent the development of IA. Puffers containing antifungal medication can be used to treat the lungs without the need to worry about the medication interactions \& side-effects in the blood. An example of this is the aerosolized amphotericin B. Its use is limited by the patients' tolerating this medication that may cause cough, nausea \& contraction of the air pathways.

The lipid preparation is better tolerated and has longer dosing interval than inhaled amphotericin B. The investigators propose a pilot study to determine the long-term safety of inhaled AmBisome administration of drug and generate the preliminary data on the effectiveness of this drug to prevent aspergillus colonization.

Read the detailed description

In this pilot study, our main aims are:

  1. To determine the safety of once weekly Inhaled AmBisome prophylaxis in preventing the development of Aspergillus colonization in lung transplant recipients at one year of prophylaxis.
  2. To generate the preliminary data on the efficacy of Inhaled AmBisome (Astellas) loading dose (1mg/kg/day for four days) initially followed by q weekly dosage to complete 1 year in lung transplant recipients as compared to no prophylaxis by assessing the rate of fungal colonization/infections between the groups.
Being tested
Ambisome ®, Regular standard of care medication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambisome ®Drug

    liposomal amphotericin B

  • Regular standard of care medicationDrug

    Drug for this group is at the physician's discretion. Patients in this group receive the standard of care medication currently implemented at the Institution. Example would be voriconazole

Study groups in NCT01254708
Study groupRoleWhat they receive
ControlActive comparatorStandard of care group. Medication as prescribed by the primary physician would be used by this group. Such medications might include azoles as voriconazole
Receives: Drug: Regular standard of care medication
liposomal amphotericin B (AmBisome ®)ExperimentalInhaled Liposomal preparation of Amphotericin B.
Receives: Drug: Ambisome ®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary Function

    Assess pulmonary function measurements i.e. changes in FEV1 (Forced Expiratory Volume 1), changes in FVC (Forced Vital Capacity) while receiving inhaled liposomal amphotericn B.

    Measured: Day 1 to 12 months

  2. Symptoms

    Assess onset of symptoms including headache, dizziness and fatigue, fever, nausea, vomiting, wheezing, cough, shortness of breath, and taste preservation, while receiving inhaled liposomal amphotericin B

    Measured: Day 1 to 12months

  3. Renal or Hepatic dysfunction and Neutropenia

    Assess the development of renal or hepatic dysfunction and neutropenia by measuring serum creatinine liver enzymes and white blood cells

    Measured: Day 1 to 12 months

Secondary outcomes (1)

  1. Presence of Invasive fungal infection

    Measure the time in months from randomization of study participants to diagnosis of invasive fungal infection (proven or probable). Measure the time in months from randomization to death for study participants.

    Assessment of the quality of life at the baseline Month 0, 3, 6, 9 and 12 months based on responses to a questionnaire. These include responses to general questions to rate the level of emotions and the general well being of the study participants. These responses are rated as never, sometimes, often or always experienced.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2010 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2014 (estimated)
  4. Study completionJan 2014 (estimated)

Why it stopped: Study has been placed on hold due to unavailability of funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254708
Sponsor's protocol ID
AGM201000428
Status last verified
Oct 2011
First submitted
22 Nov 2010
Last updated
19 Oct 2011
Results posted
No

Publications

  • Newman SP, Clarke SW. Therapeutic aerosols 1--physical and practical considerations. Thorax. 1983 Dec;38(12):881-6. doi: 10.1136/thx.38.12.881. No abstract available.

    PubMed 6364439

  • Barry PW, O'Callaghan C. Inhalational drug delivery from seven different spacer devices. Thorax. 1996 Aug;51(8):835-40. doi: 10.1136/thx.51.8.835.

    PubMed 8795674

  • Monforte V, Roman A, Gavalda J, Bravo C, Tenorio L, Ferrer A, Maestre J, Morell F. Nebulized amphotericin B prophylaxis for Aspergillus infection in lung transplantation: study of risk factors. J Heart Lung Transplant. 2001 Dec;20(12):1274-81. doi: 10.1016/s1053-2498(01)00364-3.

    PubMed 11744410

  • Calvo V, Borro JM, Morales P, Morcillo A, Vicente R, Tarrazona V, Paris F. Antifungal prophylaxis during the early postoperative period of lung transplantation. Valencia Lung Transplant Group. Chest. 1999 May;115(5):1301-4. doi: 10.1378/chest.115.5.1301.

    PubMed 10334143

  • Cicogna CE, White MH, Bernard EM, Ishimura T, Sun M, Tong WP, Armstrong D. Efficacy of prophylactic aerosol amphotericin B lipid complex in a rat model of pulmonary aspergillosis. Antimicrob Agents Chemother. 1997 Feb;41(2):259-61. doi: 10.1128/AAC.41.2.259.

    PubMed 9021176

  • Drew RH, Dodds Ashley E, Benjamin DK Jr, Duane Davis R, Palmer SM, Perfect JR. Comparative safety of amphotericin B lipid complex and amphotericin B deoxycholate as aerosolized antifungal prophylaxis in lung-transplant recipients. Transplantation. 2004 Jan 27;77(2):232-7. doi: 10.1097/01.TP.0000101516.08327.A9.

    PubMed 14742987

  • Palmer SM, Drew RH, Whitehouse JD, Tapson VF, Davis RD, McConnell RR, Kanj SS, Perfect JR. Safety of aerosolized amphotericin B lipid complex in lung transplant recipients. Transplantation. 2001 Aug 15;72(3):545-8. doi: 10.1097/00007890-200108150-00036.

    PubMed 11502995

  • Schwartz S, Behre G, Heinemann V, Wandt H, Schilling E, Arning M, Trittin A, Kern WV, Boenisch O, Bosse D, Lenz K, Ludwig WD, Hiddemann W, Siegert W, Beyer J. Aerosolized amphotericin B inhalations as prophylaxis of invasive aspergillus infections during prolonged neutropenia: results of a prospective randomized multicenter trial. Blood. 1999 Jun 1;93(11):3654-61.

    PubMed 10339471

  • Corcoran TE, Venkataramanan R, Mihelc KM, Marcinkowski AL, Ou J, McCook BM, Weber L, Carey ME, Paterson DL, Pilewski JM, McCurry KR, Husain S. Aerosol deposition of lipid complex amphotericin-B (Abelcet) in lung transplant recipients. Am J Transplant. 2006 Nov;6(11):2765-73. doi: 10.1111/j.1600-6143.2006.01529.x.

    PubMed 17049064

  • Monforte V, Roman A, Gavalda J, Lopez R, Pou L, Simo M, Aguade S, Soriano B, Bravo C, Morell F. Nebulized amphotericin B concentration and distribution in the respiratory tract of lung-transplanted patients. Transplantation. 2003 May 15;75(9):1571-4. doi: 10.1097/01.TP.0000054233.60100.7A.

    PubMed 12792517

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ambisome ® in people with Lung Transplant Recipient, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Function (time frame: Day 1 to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01254708, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2011.

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