RECRUITING

Platform Trial For Cryptococcal Meningitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cryptococcal meningitis is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in low and middle income countries where the ongoing HIV/AIDS pandemic increases the risk of cryptococcosis among persons living with HIV infection. The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades. Indeed, the effective delivery of these first line therapy in Africa can lower mortality to 25%. However, several challenges exist. First, even while 5-FC is included on the WHO list of essential medicines, the availability of 5-FC worldwide is limited. Second, liposomal amphotericin (Ambisome ®) is currently available from a single source supplier, creating risk. Third, current therapies have substantial toxicity. Lastly, with widespread agricultural fungicide use of azoles, the median fluconazole minimum inhibitory concentration (MIC50 ) for Cryptococcus has doubled since 2013. Globally, new or improved antifungals are needed for cryptococcal meningitis, particularly those which have less toxicity, greater efficacy, a prolonged half-life, and minimal drug-drug interactions. As multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.

Official Title

Platform Trial For Cryptococcal Meningitis

Quick Facts

Study Start:2025-05-28
Study Completion:2032-04-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06666322

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * CSF cryptococcal antigen (CrAg) positive meningitis
  2. * HIV positive
  3. * Ability and willingness to provide informed consent
  4. * Willing to receive protocol-specified lumbar punctures
  5. * Age \>= 18 years
  6. * Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix).
  1. * Received \>= 3 doses of antifungal therapy for meningitis treatment or \> 6mg/kg of liposomal amphotericin B cumulatively within prior 30 days
  2. * Inability to take enteral (oral or nasogastric) medicine
  3. * Cannot or unlikely to attend regular clinic visits
  4. * Receiving chemotherapy or corticosteroids
  5. * Receiving hemodialysis or known liver cirrhosis
  6. * Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
  7. * Pregnancy or breastfeeding
  8. * Previous administration of investigational study drug
  9. * Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
  10. * Trial Appendix study-drug specific eligibility criteria

Contacts and Locations

Study Contact

David Boulware, MD, MPH
CONTACT
boulw001@umn.edu

Principal Investigator

David R Boulware, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Minnesota
David B Meya, MBChB, MMed, PhD
PRINCIPAL_INVESTIGATOR
Uganda

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • David R Boulware, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • David B Meya, MBChB, MMed, PhD, PRINCIPAL_INVESTIGATOR, Uganda

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 Registration Dates

Study Start Date2025-05-28
Study Completion Date2032-04-21

Study Record Updates

Study Start Date2025-05-28
Study Completion Date2032-04-21

Terms related to this study

Additional Relevant MeSH Terms

  • Hiv
  • Cryptococcal Meningitis