NCT00263315

Brief Summary

A Phase II/III randomized double-blind study comparing the safety and the efficacy of a weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

December 7, 2005

Last Update Submit

August 17, 2006

Conditions

Aspergillosis

Keywords

aspergillosismycosisneutropeniaprimary preventionhematologic diseasesamphotericin BAmBisomeliposomal amphotericin B

Outcome Measures

Primary Outcomes (2)

  • SAFETY: Discontinuation for >1week due to intolerance

  • EFFICACY: Proven/probable invasive pulmonary aspergillosis

Secondary Outcomes (11)

  • SAFETY STUDY:

  • A probably or definitely related AE of the respiratory tract (CTC grade > 2)

  • Any probably or definitely related AE by type and severity (CTC grade > 2)

  • Requirement of pre-medication to tolerate nebulization of the study drug

  • Spirometric changes after inhalation

  • +6 more secondary outcomes

Interventions

nebulised liposomal amphotericin BDRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female hospitalized patients aged \> 18 yr
  • The patient has a hematologic malignancy or will receive a bone-marrow transplant
  • The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission
  • The expected duration of severe neutropenia (PMN\<0.5x10\*9/L) following study entry is \> 10 days
  • The patient is receiving oral antibiotic prophylaxis and fluconazole
  • Written informed consent has been obtained

You may not qualify if:

  • The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry
  • The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry
  • Known hypersensitivity to amphotericin B
  • Any evidence of pneumonia or pneumonitis at trial entry
  • Any impossibility to use a nebulizer properly
  • Expected survival \< 3 months at entry
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus MC centrumlocatie

Rotterdam, Netherlands

Location

Erasmus MC locatie Daniel den Hoed

Rotterdam, Netherlands

Location

Related Publications (3)

  • Schmitt HJ, Bernard EM, Andrade J, Edwards F, Schmitt B, Armstrong D. MIC and fungicidal activity of terbinafine against clinical isolates of Aspergillus spp. Antimicrob Agents Chemother. 1988 May;32(5):780-1. doi: 10.1128/AAC.32.5.780.

    PMID: 3134851BACKGROUND

  • 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.

    PMID: 9021176BACKGROUND

  • 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.

    PMID: 10339471BACKGROUND

Related Links

MeSH Terms

Conditions

AspergillosisMycosesNeutropeniaHematologic Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsAgranulocytosisLeukopeniaCytopeniaHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Bart JA Rijnders, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Siem de Marie, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Jan J Cornelissen, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Lennert Slobbe, MD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • A Vulto, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • M J Becker, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 8, 2005

Study Start

January 1, 2000

Study Completion

May 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

NL(2)