Trial reportJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2020
A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients.
Trial report in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01974375 (Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.
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.
Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Guideline
- Secondary Analysis of a Systematic Review: Are Antifungal Noninferiority Trials at Risk of Eroding Effectiveness Because of Biocreep?Antimicrobial agents and chemotherapy · 2022Pooled it
- Pooled it
- Early Tacrolimus C0/D Ratio and Subsequent Proven Invasive Fungal Disease After Liver Transplantation with Routine Early Echinocandin Prophylaxis.Infection and drug resistance · 2026Article
- Advancing Adjuvant Immunotherapy in Hepatocellular Carcinoma: A Comprehensive Review.ImmunoTargets and therapy · 2025Review
- The predictors of fungal infections after liver transplantation and the influence of fungal infections on outcomes.Clinical and experimental medicine · 2024Article
- Primary prophylaxis of invasive fungal diseases in patients with haematological malignancies: 2022 update of the recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology (DGHO).The Journal of antimicrobial chemotherapy · 2023Review
- Invasive Fungal Infections: The Early Killer after Liver Transplantation.Journal of fungi (Basel, Switzerland) · 2023Article
- The impact of gene polymorphism and hepatic insufficiency on voriconazole dose adjustment in invasive fungal infection individuals.Frontiers in genetics · 2023Review
- [Consensus on diagnosis and treatment of invasive fungal infection in patients with severe liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022Article
- Fungal infections following liver transplantation.World journal of hepatology · 2021Review
- Fungal Infections in Liver Transplant Recipients.Journal of fungi (Basel, Switzerland) · 2021Review
- Invasive fungal infection before and after liver transplantation.World journal of gastroenterology · 2020Review
- Risk factors associated with invasive fungal disease post-liver transplantation.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough invasive fungal infections (IFIs) contribute to substantial morbidity and mortality in liver transplant recipients, only a few randomized studies analyzed the results of antifungal prophylaxis with echinocandins. The aim of this open-label, non-inferiority study was to evaluate the efficacy and safety of micafungin in the prophylaxis of IFIs in living-donor liver transplantation recipients (LDLTRs), with fluconazole as the comparator.
methodsLDLTRs (N = 172) from five centers were randomized 1:1 to receive intravenous micafungin 100 mg/day or fluconazole 100~200 mg/day (intravenous or oral). A non-inferiority of micafungin was tested against fluconazole.
resultsThe per-protocol set included 144 patients without major clinical trial protocol violations: 69 from the micafungin group and 75 from the fluconazole group. Mean age of the study patients was 54.2 years and mean model for end-stage liver disease (MELD) score amounted to 16.5. Clinical success rates in the micafungin and fluconazole groups were 95.65% and 96.10%, respectively (difference: - 0.45%; 90% confidence interval [CI]: - 6.93%, 5.59%), which demonstrated micafungin's non-inferiority (the lower bound for the 90% CI exceeded - 10%). The study groups did not differ significantly in terms of the secondary efficacy endpoints: absence of IFIs at the end of the prophylaxis and the end of the study, time to proven IFI, fungal-free survival, and adverse reactions. A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved.
conclusionMicafungin can be used as an alternative to fluconazole in the prevention of IFIs in LDLTRs. CLINICAL TRIALS REGISTRATION: NCT01974375.
Indexed as
Identifiers
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.