Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Oral Lipid Nanocrystal Amphotericin B for Cryptococcal Meningitis: A Randomized Clinical Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04031833 (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial), which is not on this map. Cited by 45 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial
Who cites it
45 citing papers in PubMed, 57 citations in OpenAlex.
- Evaluating the Use of Lower Dose Flucytosine for the Treatment of Cryptococcal Meningitis: A Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Successful salvage treatment ofMedical mycology case reports · 2026Article
- New approaches for cryptococcosis treatment and prevention-a systematic review.Journal of thoracic disease · 2026Review
- Evaluating Desirability of Outcome Ranking (DOOR) and Win Ratio for Hierarchical Composite Endpoints in Cryptococcal Meningitis Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- New Perspectives on Antimicrobial Agents: Fosmanogepix.Antimicrobial agents and chemotherapy · 2026Review
- Contribution of fungal diseases to the U.S. chronic disease burden.Clinical microbiology reviews · 2026Review
- HIV-Associated Cryptococcal Meningitis: A Call for Action for New Treatment Options.Therapeutics · 2026Article
- Pulmonary Aspergillosis Treated With Oral Amphotericin B (MAT2203) in a Patient With HIV-Related Cryptococcal Meningitis.Clinical case reports · 2026Article
- Assessing Statistical Methods for Estimating the Cerebrospinal Fluid Early Fungicidal Activity as an Endpoint for Cryptococcal Meningitis Clinical Trials: A Systematic Review and Simulation Study.Open forum infectious diseases · 2026Article
- Successful Control of RefractoryOpen forum infectious diseases · 2026Article
- Analytical validation: Comparison of two laboratory-based methods for CSF quantitative cryptococcal cultures.Medical mycology · 2026Article
- Nanoparticle-Based Drug Delivery Systems: Current Advances and Future Directions.Current drug targets · 2026Review
- Revisiting Immune-Mediated Mechanisms as Drivers of Cryptococcal Immune Reconstitution Inflammatory Syndrome.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Target product profile and discovery and development path for novel cryptococcal disease treatments.The Journal of infection · 2025Review
- Can liposomal amphotericin B be used as a preventive measure for cryptococcal meningitis?Expert review of anti-infective therapy · 2025Article
- Endemic Mycoses for Pulmonary Clinicians: From Nodules to ARDS.CHEST pulmonary · 2025Review
- Next-generation antifungal drugs: Mechanisms, efficacy, and clinical prospects.Acta pharmaceutica Sinica. B · 2025Review
- Experience of research nurses with oral encochleated amphotericin B for treatment of cryptococcal meningitis in a resource-limited setting.BMC infectious diseases · 2025Observational
- Etiology and Outcomes of Meningitis among Adults in Three Ugandan Referral Hospitals, 2018-2023: A Prospective Cohort Study in a High-HIV Endemic Setting.The American journal of tropical medicine and hygiene · 2025Observational
- Chronic meningitis: diagnostic and therapeutic challenges.Current opinion in infectious diseases · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
29 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundAmphotericin B is the gold standard treatment for severe mycoses. A new orally delivered, less-toxic formulation of amphotericin has been developed.
methodsIn our randomized clinical trial, we tested oral lipid nanocrystal (LNC) amphotericin B (MAT2203, Matinas Biopharma) vs intravenous (IV) amphotericin for human immunodeficiency virus-associated cryptococcal meningitis in 4 sequential cohorts. Two pilot cohorts assessed safety and tolerability (n = 10 each), and 2 cohorts assessed efficacy with/without 2 IV loading doses (n = 40 each). The experimental arm received 1.8 g/d oral LNC amphotericin through 2 weeks with 100 mg/kg/d flucytosine, then 1.2 g/d LNC amphotericin through 6 weeks. The randomized control arm (n = 41) received 7 days of IV amphotericin with flucytosine, then 7 days of fluconazole 1200 mg/d. The primary end point was cerebrospinal fluid (CSF) early fungicidal activity (EFA).
resultsWe randomized 80 participants to oral LNC amphotericin + flucytosine with (n = 40) and without (n = 40) 2 IV loading doses and 41 control participants to IV amphotericin + flucytosine. Mean EFA was 0.40 log10 colony-forming units (CFU)/mL/d for all-oral LNC amphotericin, 0.42 log10 Cryptococcus CFU/mL/d for oral LNC amphotericin with IV loading doses, and 0.46 log10 CFU/mL/d for IV amphotericin controls. LNC amphotericin groups achieved 2-week CSF sterility in 63% (44 of 70) vs 68% (23 of 34) of controls. The 18-week survival was 85% (34 of 40) with all-oral LNC amphotericin, 90% (36 of 40) with oral LNC amphotericin given IV loading doses, and 85% (35 of 41) with IV amphotericin.Grade 3-4 laboratory adverse events occurred less frequently in LNC amphotericin groups (41%) than the IV amphotericin group (61%, P = .05), particularly for anemia (21% vs 44%; P = .01) and potassium (5% vs 17%; P = .04).
conclusionsThis new oral amphotericin B LNC formulation appears promising for cryptococcal meningitis with antifungal activity, similar survival, and less toxicity than IV amphotericin. CLINICAL TRIALS REGISTRATION: NCT04031833.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.