King's Invasive Aspergillosis Study II

April 1, 2020 updated by: King's College Hospital NHS Trust

Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

  1. Refusal or inability to consent
  2. Autologous HSCT
  3. Contraindicated medications
  4. Current evidence of IFD diagnosis or treatment
  5. Enrolled in another study requiring alternative antifungal prophylaxis or treatment
  6. Women who are pregnant or lactating
  7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Posaconazole
Drug: Posaconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2016

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIASII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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