NCT00177684

Brief Summary

The purpose of this study is to determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive for invasive aspergillosis (IA) in their lungs. Additionally, the investigators hope to determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 17, 2008

Status Verified

December 1, 2008

First QC Date

September 13, 2005

Last Update Submit

December 16, 2008

Conditions

Lung TransplantationFungal Infections

Outcome Measures

Primary Outcomes (1)

  • To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®).

Secondary Outcomes (1)

  • To determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of a four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization in lung transplant recipients.

Interventions

Amphotericin BDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnant women or women who are currently breast-feeding an infant
  • Hypersensitive to amphotericin deoxycholate or lipid complex amphotericin B (Abelcet ®)
  • Have a documented fungal infection
  • Receipt of inhalational or IV amphotericin B within last 30 days
  • Have a Temp ≥ 38ºC
  • Hypoxemic (pulse oximeter \< 92% at room air.)
  • On mechanical ventilator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Husain S, Capitano B, Corcoran T, Studer SM, Crespo M, Johnson B, Pilewski JM, Shutt K, Pakstis DL, Zhang S, Carey ME, Paterson DL, McCurry KR, Venkataramanan R. Intrapulmonary disposition of amphotericin B after aerosolized delivery of amphotericin B lipid complex (Abelcet; ABLC) in lung transplant recipients. Transplantation. 2010 Dec 15;90(11):1215-9. doi: 10.1097/TP.0b013e3181f995ea.

    PMID: 20881664DERIVED

MeSH Terms

Conditions

Mycoses

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Mark Ludwig

    Enzon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2004

Study Completion

September 1, 2005

Last Updated

December 17, 2008

Record last verified: 2008-12

Locations

US(1)