NCT06666322RecruitingPhase 2/3
Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)
Platform Trial For Cryptococcal Meningitis
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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 antifungal regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 28 May 2025
- Primary completion date
- 21 Apr 2032
- Lead sponsor
- David Boulware
- Diseases
- HIV
- NCT number
- NCT06666322
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 2000
- From 28 May 2025 to the primary completion date, 21 Apr 2032
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received 3 or more doses of antifungal therapy for meningitis within last 30 days
- Receiving chemotherapy or corticosteroids
- Receiving hemodialysis or known liver cirrhosis
- Previous administration of investigational study drug
- Trial Appendix study-drug specific eligibility criteria
Other illness
- Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
- Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
Other
- Inability to take enteral (oral or nasogastric) medicine
- Cannot or unlikely to attend regular clinic visits
- Pregnancy or breastfeeding
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Infectious Diseases Institute Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| Mbarara University of Science and Technology Coordinator of this site? Confirm its status | Mbarara | Uganda | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.