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Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllDavid Boulware
NCT06666322 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 thera

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📋 Eligibility rules (as published)
Inclusion Criteria: * CSF cryptococcal antigen (CrAg) positive meningitis * Living with HIV * Ability and willingness to provide informed consent * Willing to receive protocol-specified lumbar punctures * Age \>= 18 years * 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). Exclusion Criteria: * Received 3 or more doses of antifungal therapy for meningitis within last 30 days * Inability to take enteral (oral or nasogastric) medicine * Cannot or unlikely to attend regular clinic visits * Receiving chemotherapy or corticosteroids * Receiving hemodialysis or known liver cirrhosis * Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS) * Pregnancy or breastfeeding * Previous administration of investigational study drug * Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments * Trial Appendix study-drug specific eligibility criteria
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What it tests

  • Standard of care
  • Oteseconazole - antifungal therapy 1
  • Turletricin injection - antifungal therapy 2
  • Turletricin Injection - antifungal therapy 3
  • Oteseconazole with Flucytosine - antifungal therapy 4
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Where

2 sites
Infectious Diseases Institute
Kampala, Uganda
Mbarara University of Science and Technology
Mbarara, Uganda
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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