Oral Voriconazole vs. Amphotericin B Plus Flucytosine for Fungal Peritonitis in Peritoneal Dialysis: A Multicenter Randomized Noninferiority Trial with Stratification by Fungal Type
Bibliographic record
Abstract
Background: Fungal peritonitis is a life-threatening complication of peritoneal dialysis (PD), yet robust evidence to guide empiric antifungal therapy is lacking. This multicenter, randomized controlled trial assessed the noninferiority of oral voriconazole vs. intravenous amphotericin B plus oral flucytosine for initial treatment of fungal peritonitis. Methods: In this open-label, muti-centered trial (TCTR20210316001), 91 PD patients with confirmed fungal peritonitis were randomized 1:1 to voriconazole or combination therapy within 24 hours of timely PD catheter removal (within 3 days). Randomization was stratified by fungal type (yeast vs. mold) and site. The primary outcome was peritonitis-related death within 30 days. Secondary outcomes included clinical response, recurrence, mortality, and HD transfer. Analyses followed intention-to-treat principles using risk differences (RD), risk ratios (RR), and Kaplan-Meier survival. Results: Peritonitis-related death occurred in 11% of the voriconazole group vs. 24% with combination therapy (RD -13.6%; 95% CI -29.0%, 1.9%), meeting the 15% noninferiority margin. Kaplan-Meier survival curves trended in favor of voriconazole (HR 0.40; 95% CI 0.14, 1.16). Primary response was higher with voriconazole (87% vs. 71%; RD 15.8%, 95% CI -0.6%, 32.3%), whilst recurrence was lower (2.2% vs. 8.9%). Long-term mortality was numerically lower in the voriconazole group at 12 months (22% vs. 36%; RD -13.8%, 95% CI -32.2%, 4.6%) (Figure 1). Adverse events and PD resumption rates were comparable. Hyaline molds predominated (65%) over yeasts (35%), with no difference in treatment responses by fungal type. Notably, 30% of isolates were voriconazole-resistant, associated with poorer response and possibly required initial combination therapy. Conclusion: Voriconazole monotherapy was noninferior to amphotericin B plus flucytosine for initial management of PD-associated fungal peritonitis. Its oral formulation, favorable safety profile, and outpatient feasibility suggest it may be a viable first-line alternative. Further studies are needed to assess efficacy in patients with drug-resistant fungi. Funding: Government Support – Non-U.S.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".