King's Invasive Aspergillosis Study II

• Sponsor: King's College Hospital NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02875743
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Actual Duration (Months): 34.8
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: N/A
• 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: Dec 7, 2016
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Posaconazole	Drug: Posaconazole

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King's College Hospital NHS Foundation Trust	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

• King's College Hospital NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: King's College Hospital NHS Trust
• ClinicalTrials.gov Identifier: NCT02875743
• Other Study ID Numbers: KIASII
• First Posted: Aug 23, 2016
• Last Update Posted: Apr 2, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Anemia, Aplastic; Posaconazole

Study Results

No Results Posted as of Apr 2, 2020