NCT02875743

Brief Summary

Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation. This current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2016

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 7, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

April 2, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

August 18, 2016

Last Update Submit

April 1, 2020

Conditions

Aplastic AnemiaLeukemia, Myeloid, AcuteMyelodysplastic SyndromesBone Marrow Transplantation

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)

    24 weeks

Study Arms (1)

Posaconazole

EXPERIMENTAL
Drug: Posaconazole

Interventions

PosaconazoleDRUG
Posaconazole

Eligibility Criteria

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

You may qualify if:

  • Adult ≥ 18 years
  • Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT
  • Able to swallow and retain orally administered medication

You may not qualify if:

  • Refusal or inability to consent
  • Autologous HSCT
  • Contraindicated medications
  • Current evidence of IFD diagnosis or treatment
  • Enrolled in another study requiring alternative antifungal prophylaxis or treatment
  • Women who are pregnant or lactating
  • Women who are unable to use and apply with effective contraception without interruption throughout the duration of study drug therapy and not willing to have further pregnancy tests during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Anemia, AplasticLeukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

posaconazole

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

December 7, 2016

Primary Completion

October 31, 2018

Study Completion

October 31, 2019

Last Updated

April 2, 2020

Record last verified: 2020-04

Locations

GB(1)