Antifungal Therapies for Cryptococcal Meningitis
(PLATFORM-CM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new antifungal treatments for cryptococcal meningitis, a deadly brain infection that particularly affects individuals with HIV. The trial compares existing treatments with new ones to identify options that are more effective and have fewer side effects. Participants will join different groups to test either standard care or one of the new experimental treatments, such as Oteseconazole or Sfu-AM2-19 Injection. The trial seeks individuals who are HIV positive and have been diagnosed with cryptococcal meningitis through a specific test (CSF cryptococcal antigen positive). As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving chemotherapy or corticosteroids. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that some antifungal treatments for cryptococcal meningitis improve survival rates. Specifically, a combination of amphotericin B and flucytosine leads to better survival than amphotericin B alone, indicating that certain antifungal treatments can be effective and relatively safe.
Research on Oteseconazole suggests it may cause fewer serious side effects, such as anemia (low red blood cell count) and hypokalemia (low potassium levels), compared to other treatments, making it a potentially safer option.
While specific information on Antifungal therapies 3 and 4, or Sfu-AM2-19 Injection, is limited, the trial phase indicates these treatments have demonstrated some safety in earlier research. Phase 2 and 3 trials typically proceed when initial safety data is promising, suggesting any serious issues would likely have been identified earlier.
Always discuss with a healthcare provider for personalized advice.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for cryptococcal meningitis because they offer potentially groundbreaking approaches compared to the current standard of care, which typically includes antifungal medications like amphotericin B and fluconazole. Oteseconazole is distinctive because it targets fungal cells more selectively with potentially fewer side effects. Sfu-AM2-19 Injection introduces a novel formulation that may enhance drug delivery and effectiveness. These innovations could lead to more efficient, safer, and faster-acting therapies for patients battling this serious condition.
What evidence suggests that this trial's treatments could be effective for cryptococcal meningitis?
This trial will compare various antifungal therapies for cryptococcal meningitis. Studies have shown that antifungal treatments can significantly reduce the risk of death in people with this condition. Treatments using amphotericin and flucytosine have been particularly successful, lowering death rates to about 24.2% after 10 weeks. In this trial, participants may receive Oteseconazole, which research suggests shows promising early results, clearing the infection from the cerebrospinal fluid as effectively as current treatments. Another option in this trial is the Sfu-AM2-19 Injection, studied for its ability to clear the infection with manageable side effects. These promising treatments aim to improve survival rates and reduce the high risk of death from this serious fungal infection.678910
Who Is on the Research Team?
David R Boulware, MD, MPH
Principal Investigator
University of Minnesota
David B Meya, MBChB, MMed, PhD
Principal Investigator
Uganda
Are You a Good Fit for This Trial?
This trial is for individuals with cryptococcal meningitis, often linked to HIV. Participants must consent to the study procedures, including lumbar punctures, and women able to become pregnant must use contraception. Those with CSF cryptococcal antigen positive meningitis are eligible.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard of care or one of the experimental antifungal therapies
Follow-up
Participants are monitored for safety and effectiveness after treatment, including survival and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Antifungal therapy 3
- Antifungal therapy 4
- Oteseconazole
- Sfu-AM2-19 Injection
Trial Overview
The trial is testing multiple antifungal therapies against cryptococcal meningitis: standard care, Oteseconazole, Sfu-AM2-19 Injection, and two other unnamed antifungals. It aims to find treatments that are less toxic and more effective.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Active Control
randomized to experimental antifungal therapy #4
randomized to experimental antifungal therapy #3
randomized to experimental antifungal therapy #2
randomized to experimental antifungal therapy #1
randomized to standard of care
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
One-year Mortality Outcomes From the Advancing ...
The results also confirm that after 10 weeks, mortality rates decrease, with a general flattening out of survival curves in the context of effective antifungal ...
Antifungal Combinations for Treatment of Cryptococcal ...
One week of amphotericin B plus flucytosine and 2 weeks of fluconazole plus flucytosine were effective as induction therapy for cryptococcal meningitis in ...
Approaches to Antifungal Therapies and Their Effectiveness ...
Combination antifungal therapy reduces mortality in severe cryptococcal meningitis, abstr M-1141a. Abstr. 51st Intersci. Conf. Antimicrob. Agents Chemother ...
4.
clinicalinfo.hiv.gov
clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/cryptococcosisCryptococcosis: Adult and Adolescent OIs | NIH
In a large clinical trial in people with AIDS and cryptococcal meningitis, increased ICP was associated with 92% of deaths during the first 2 ...
Correlation of anti-fungal susceptibility with clinical outcomes ...
Of 46 patients with cryptococcal meningitis identified, 21 were cured after 10 weeks of treatment. Overall, 12 strains (26.1%) were resistant to ...
Cryptococcal Meningitis - StatPearls - NCBI Bookshelf - NIH
Complications include the following[4]: Persistent Infection - Persistently positive results of cultures of CSF after 4 weeks of proven antifungal therapy at ...
Combination Antifungal Therapy for Cryptococcal Meningitis
Amphotericin B plus flucytosine, as compared with amphotericin B alone, is associated with improved survival among patients with cryptococcal meningitis.
Recent Antiretroviral Therapy Initiation Is Associated With ...
Mortality from cryptococcal meningitis was higher in recent ART initiators. ART interruption in this group may lead to improved outcomes. HIV, ...
Determinants of mortality in HIV-associated cryptococcal ...
35 % mortality in HIV-CM patients with CD4 < 50, cerebral edema, and shortened AmB therapy as key predictors. · Cerebral edema on MRI strongly predicts mortality ...
Three Induction Treatments on Cryptococcal Meningitis
Also called a data safety and monitoring board, or DSMB. ... To observe the rate of hypokalemia in three groups during antifungal therapy, 0-90 days. anemia ...
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