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King's Invasive Aspergillosis Study II

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ClinicalTrials.gov Identifier: NCT02875743
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.


Condition or disease Intervention/treatment Phase
Aplastic Anemia Leukemia, Myeloid, Acute Myelodysplastic Syndromes Bone Marrow Transplantation Drug: Posaconazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis
Actual Study Start Date : December 7, 2016
Actual Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2019


Arm Intervention/treatment
Experimental: Posaconazole Drug: Posaconazole



Primary Outcome Measures :
  1. Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft) [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875743


Locations
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United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust

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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02875743     History of Changes
Other Study ID Numbers: KIASII
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Anemia, Aplastic
Bone Marrow Diseases
Hematologic Diseases
Neoplasms
Anemia
Leukemia
Neoplasms by Histologic Type
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs