Highlighting gaps in paediatric antifungal drugs: a qualitative synthesis of current data from the International Pediatric Association AMR Working Group

1 Introduction

Fungi can cause superficial, cutaneous/mucosal/subcutaneous or invasive fungal diseases (IFDs). IFDs are severe illnesses that are diagnosed when fungi are shown to be invasive into specific organs by their isolation from blood, other sterile sites and tissues. IFDs constitute a substantial yet often underestimated global health burden in neonates and paediatric populations, particularly in low- and middle-income countries (LMICs), where diagnostic capacity and clinical expertise are frequently insufficient to detect and report these infections accurately (1, 2). Among very low-birth-weight infants (VLBWs), systemic fungal infection is a significant hospital-acquired condition, affecting up to 9% and associated with mortality rates as high as one-third of affected patients (3). Globally, invasive candidiasis accounts for an estimated 700,000 cases annually, with case-fatality rates that may exceed 40% (4, 5). The number of immunocompromised children, such as those undergoing chemotherapy or haematopoietic stem cell transplantation is rising, confirming expectations of increasing IFD incidence (6). Hospital-acquired fungal pathogens, including rare species, pose a particular threat through nosocomial outbreaks. Candidozyma auris (formerly Candida auris), hereafter C. auris, a multidrug-resistant yeast, is increasingly recognised as a cause of neonatal intensive care unit (NICU) outbreaks with grave outcomes (7). Moreover, climate change is shifting ecological niches and expanding the distribution of rare fungal pathogens, increasing the likelihood that atypical regional infections will begin to appear in paediatric populations, a concern of growing urgency in both high- and low-resource settings (8).

2 Scope and methodology

A structured review was conducted to identify clinical trials and published case reports involving novel antifungal agents with potential applicability in paediatric populations. Searches were performed in ClinicalTrials.gov and PubMed during July–August 2025, using the drug names rezafungin, ibrexafungerp, fosmanogepix, olorofim, and opelconazole as primary keywords. On ClinicalTrials.gov, all registered interventional (Phase 1–3) and observational or registry studies were screened for relevance. Data were extracted on trial phase, study design, inclusion and exclusion criteria, paediatric age eligibility, geographic recruitment, and formulation characteristics. In PubMed, the search was restricted to peer-reviewed articles reporting clinical data, expanded access use, or compassionate use cases involving the selected agents in paediatric or adolescent patients. Expanded access was defined as administration of an investigational product outside a clinical trial under a formal regulatory pathway such as the U.S. FDA’s Expanded Access Program or equivalent international frameworks, while compassionate use referred to similar non-trial access in urgent, life-threatening scenarios without alternative treatment options. Studies were eligible if they involved at least one of the target antifungal agents, provided information on dosing, formulation, or clinical outcomes, and included participants under 18. Titles and abstracts were screened, and full texts of potentially relevant studies were reviewed in detail. Data from both trial registries and the published literature were synthesised to evaluate the extent of paediatric inclusion, the availability of age-appropriate formulations, and reported clinical outcomes in children receiving the identified agents.

3 Burden of antifungal resistance in children and neonates

Antifungal resistance (AFR) is expanding globally and threatens the limited number of drug classes available for invasive fungal disease (9). In 2022, the World Health Organization (WHO) released the first Fungal Priority Pathogens List, designating a “critical” tier that includes C. auris, Aspergillus fumigatus, Cryptococcus neoformans and C. albicans, underscoring urgent needs in surveillance, diagnostics, and research & development (R&D) (10). Parallel global analyses highlight three emblematic AFR threats: multidrug-resistant C. auris in healthcare settings, azole-resistant A. fumigatus linked in part to environmental azole use and the dermatophyte Trichophyton indotineae with widespread terbinafine resistance (11). Both of these threats have since been characterised in greater detail: the global prevalence of multidrug-resistant C. auris in humans between 2015 and 2024 has been estimated in a systematic review and meta-analysis (12), and the drivers of azole-resistant A. fumigatus, together with the measures available to contain it, have been reviewed for the African setting (13).

Paediatric data echo these trends: non-albicans Candida (NAC) species are increasingly isolated in children, often with reduced azole susceptibility, and contemporary cohorts continue to report fluconazole resistance among paediatric candidaemia isolates, with mortality pressures greatest in high-risk units (14). In the neoOBS study, conducted in LMIC settings, of the 127 neonates who had candidaemia, 35% were C. albicans, 30% C. parapsilosis and 14% C. auris. Importantly, 59% of C. parapsilosis were fluconazole resistant (15, 16). In Colombia, a cluster of neonatal infections caused by C. auris at a large referral centre underscored the diagnostic challenges and variable mortality (17). A broader epidemiological study reported 34 paediatric bloodstream infection cases due to C. auris in Colombian hospitals, with an in-hospital mortality of approximately 41%, and highlighted the capacity for healthcare-associated cross-transmission (18). In fluconazole resistant candidiasis among neonates, in situations where amphotericin B is contraindicated because of its adverse-effect profile, micafungin is in practice the principal remaining option, the other echinocandins carrying more restricted neonatal labelling, and in some areas its use is limited by high cost (19). This example highlights the limited armamentarium for treatment of AFR.

It is worth stating the neonatal case separately, because evidence generated in older children does not transfer to it and the two are too often treated as one population. The epidemiology differs first: systemic fungal infection affects up to 9% of very low-birth-weight infants and kills close to a third of those affected (3), a burden with no counterpart in older paediatric cohorts, and in low- and middle-income settings the pooled incidence of neonatal invasive candidiasis is higher still (2). The species distribution differs next. In the neoOBS cohort of 127 neonates with candidaemia, C. parapsilosis accounted for 30% of isolates and 59% of those were fluconazole-resistant, a pattern that would be unusual in older children (15, 16), while C. auris has moved from an occasional import to a recognised cause of neonatal intensive care unit outbreaks (7). Pharmacology differs most sharply of all: micafungin requires higher weight-based doses in neonates than in older children or adults because clearance is greater, and dissemination to the central nervous system is frequent enough in this group that central nervous system penetration becomes a criterion for agent selection rather than a secondary consideration (15, 19). Neither finding could have been arrived at by extrapolation from older children, and both illustrate why the framework set out below treats neonatal inclusion as a requirement in its own right rather than as a subset of paediatric inclusion.

4 Lack of inclusivity in paediatric antifungal research and trials

Children, particularly neonates, continue to be significantly underrepresented in antifungal research and are often described as “therapeutic orphans” due to systemic exclusion from trials and limited access to innovative therapies (20). There is also a remarkably lower number of trials of antifungal drugs compared to antibiotic trials for sepsis. Paediatric patients differ in metabolism, pharmacokinetics (PK), and risk of adverse events compared to adults, yet paediatric-specific evidence, especially in antifungal pharmacology, is scarce. A noteworthy example is micafungin, which in neonates is dosed higher than in older children and adults owing to the greater body clearance demonstrated in PK studies (19). Historical exclusion arose from ethical and regulatory hurdles, rarity of paediatric fungal diseases, complexities of parental consent, and limited commercial interest. Although regulations like the European Medicines Agency (EMA) Paediatric Regulation and the United States (US) Best Pharmaceuticals for Children Act mandate paediatric investigation plans (PIPs), substantial gaps persist, particularly for neonates and off-patent drugs. Despite the escalating threat of AFR and vulnerability of paediatric populations, the antifungal research landscape remains slow: clinical trials and real-world studies specifically assessing efficacy and safety in children lag behind.

These deficits are habitually described together, yet they are not the same problem and do not yield to the same solution. The first is enrolment: children are excluded from registrational programmes altogether, or admitted so late and in such small numbers that adolescents come to stand for the whole paediatric range. Where enrolment does occur, a second deficit follows if sampling is not designed to characterise exposure, since without paediatric PK/PD data no defensible dose can be derived even for an agent that is otherwise on the market. A third arises at the regulatory step, because evidence that never reaches a submission leaves prescribing off-label and, in many health systems, unreimbursed. The fourth is pharmaceutical rather than clinical: an approved paediatric dose cannot be given to a neonate or a young infant if the only formulation is an adult tablet. The fifth appears after approval and is largely economic, since price, national registration and supply-chain barriers determine whether a licensed agent ever reaches the child in front of the clinician. Which of these binds varies by agent. For the novel compounds discussed below the constraints remain the first four, and the argument is one about research and development; for licensed agents such as micafungin and liposomal amphotericin B the evidence largely exists and the constraint in most high-burden settings is the last. Keeping them apart matters practically, because a trial, a PK study, a regulatory submission, a formulation programme and a procurement mechanism are different interventions, and only one of them closes any given gap.

It is imperative to prioritise inclusive paediatric antifungal research to generate the robust evidence required for safe and effective treatment in these highly vulnerable groups. WHO has highlighted these inequities, urging inclusive R&D and equitable access to therapeutics for children. There have been few efforts towards more inclusive studies, like the conect4children (c4c) network that enhanced paediatric trial infrastructure and engagement across Europe (21), while the Research Equity and Diversity Inclusion (READI) Innovative Health Initiative (IHI) project is developing platforms and methodologies to ensure underserved and underrepresented populations contribute to and benefit from clinical studies (22). The European Paediatric Mycology Network (EPMyN) also endeavours to bridge antifungal research gaps in children and neonates (23).

5 Current landscape with new antifungals in the pipeline

In contrast, several novel antifungal agents are in late-stage development or have recently entered the market, aiming to address gaps in treatment options for resistant or difficult-to-treat fungal infections (Tables 1, 2) (26).

Table 1. Clinical trials and ongoing studies evaluating novel antifungal agents with paediatric or adolescent inclusion.

Table 2. Published paediatric case reports and compassionate-use experience with novel antifungal agents.

Because these agents sit at very different points between discovery and the bedside, each is described below against the same set of questions: whether it holds a marketing authorisation and for which population, whether it remains investigational, whether it can be obtained outside trials through expanded access or compassionate use, whether any paediatric pharmacokinetic study has been registered, and whether paediatric clinical efficacy data exist. Judged in this way the picture is uneven, but consistent in one respect. Rezafungin and ibrexafungerp are approved agents, although their authorisations reach only adults and, for ibrexafungerp, postmenarchal adolescents. Olorofim, opelconazole and fosmanogepix remain investigational, with olorofim and fosmanogepix additionally obtainable in selected patients through expanded-access or compassionate-use routes. Only rezafungin has a registered paediatric pharmacokinetic study, and that study was terminated early. None of the five is supported by paediatric clinical efficacy data. It is worth adding that the regulatory designations appearing in several of the descriptions that follow — Orphan Drug, Breakthrough Therapy, Fast Track — are development incentives intended to accelerate a programme; they are not approvals, and they carry no implication of paediatric applicability.

• Rezafungin is a next-generation echinocandin distinguished by its extended half-life, enabling once-weekly intravenous dosing and therefore advantageous for shorter hospital stays and outpatient therapy. It was approved by the FDA and by the European Medicines Agency (EMA) in 2023 for the treatment of adult candidaemia and invasive candidiasis (27). In the phase III ReSTORE trial, rezafungin demonstrated non-inferiority to caspofungin with similar safety profiles and potential logistical advantages for early hospital discharge (28). Its PK profile suggests suitability for prophylaxis in high-risk adult populations, and the only registered paediatric study - a PK/safety trial from birth to <18 years (NCT05534529) - was terminated early after enrolling two adolescents (Table 1), so that rezafungin remains approved for adults alone, with no paediatric dosing recommendation in any jurisdiction.
• Ibrexafungerp is the first approved representative of the triterpenoid antifungal class, available as an oral formulation with activity against Candida species, including strains resistant to azoles and echinocandins, and some activity against Aspergillus spp. It offers the convenience of an oral switch from intravenous echinocandins for serious invasive fungal infections (IFI) (29). It is FDA-approved in postmenarchal female patients for recurrent vulvovaginal candidiasis (30, 31). That authorisation does not extend to invasive fungal disease, nor to girls below menarche, and the oral step-down use in invasive infection described above therefore remains investigational.
• Olorofim (F901318) is the first member of the orotomide class, targeting fungal dihydroorotate dehydrogenase, a novel mechanism distinct from existing antifungal classes. It exhibits potent in vitro activity against azole-resistant Aspergillus fumigatus, Scedosporium species, Lomentospora prolificans, and certain dimorphic fungi. Olorofim holds Orphan Drug and Breakthrough Therapy designations from the FDA. Both are development designations rather than marketing authorisations, and olorofim accordingly remains investigational, obtainable only through clinical trials or expanded-access and compassionate-use pathways. Early-phase studies have shown good tolerability and promising efficacy in salvage therapy for refractory mould infections, with pivotal trials ongoing (32).
• Opelconazole (PC-945) is an inhaled triazole designed for high pulmonary deposition and minimal systemic exposure, developed primarily for invasive pulmonary aspergillosis in immunocompromised patients (33). Phase I and II studies indicate strong antifungal activity against Aspergillus spp. with a favourable safety profile, particularly by minimising systemic triazole-related toxicity. Its delivery method makes it attractive for both treatment and prophylaxis in patients with localised pulmonary infections (34). It too remains investigational, with no marketing authorisation in any jurisdiction to date.
• Fosmanogepix (APX001) is a first-in-class inhibitor of the Gwt1 enzyme, essential for fungal cell-wall anchoring of mannoproteins (35, 36). It has broad-spectrum activity against Candida spp. (including C. auris), Aspergillus spp., Scedosporium, and Fusarium. Phase II data in adults show encouraging cure rates in invasive candidiasis, including in echinocandin-resistant cases, with good oral bioavailability and tolerability (37). Fosmanogepix is likewise investigational, and outside clinical trials it can be obtained only through an expanded-access programme (NCT06433128, Table 1).

Collectively, these agents offer novel mechanisms, expanded activity spectra, and improved pharmacological properties over existing antifungals. However, the majority of efficacy and safety data currently derive from adult studies, with paediatric and neonatal research largely absent. Given the rising burden of antifungal resistance and limited treatment options for vulnerable paediatric populations, prioritising clinical trials and real-world evidence generation in these groups is essential to translate these innovations into improved outcomes for children (38).

6 Real-world data, trials, and evidence gaps for novel antifungals in children

Reviews and regulatory analyses consistently note limited paediatric PK/pharmacodynamic (PK/PD) data, few neonatal trials, and a lag in children’s access to new agents relative to adults (26, 38). The current paediatric evidence for each agent can be summarised as follows:

• Rezafungin — adult approvals are in place; paediatric experience is limited to a PK/safety study from birth to <18 years (NCT05534529) that was terminated early after enrolment of two adolescents, with no efficacy endpoints reported to date (39).
• Ibrexafungerp — currently carries adult indications only. The three phase III vulvovaginal candidiasis trials (NCT03987620, NCT03734991, NCT04029116) enrolled females aged ≥12 years using adult oral tablets, without paediatric dose adaptation or alternative formulations (31, 40–42), and an observational pregnancy-exposure registry (NCT05908682) enrols pregnant women rather than children and follows exposed infants only as a safety outcome for up to one year after birth (Table 1), so that it yields no paediatric dosing or efficacy data; it is currently limited to a single registered site (43).
• Fosmanogepix — encouraging adult phase 2 candidaemia data (37) and preclinical and case-based evidence against rare moulds (44–46), though paediatric efficacy data are not yet available; its expanded-access programme (NCT06433128) is open to all ages (Table 1) but has not, to date, reported paediatric use (47).
• Olorofim — early paediatric exposure from compassionate/expanded-access use in older children and adolescents (52), while the phase IIb study in rare and resistant moulds (NCT03583164) enrolled from ≥16 years (48); controlled paediatric data remain limited.
• Opelconazole — progressing in invasive pulmonary aspergillosis via an attractive inhaled route, without paediatric efficacy datasets to date (49, 50).

Taken together, across the seven analysed trial and expanded-access records, only NCT05534529 was designed to include a broad paediatric cohort (birth to <18 years); the remainder were restricted to adolescents or adults, and no phase III programme enrolled children younger than 12 years. Reported formulations were predominantly adult oral tablets, with little development of low-weight or non-oral options (e.g., dispersible or liquid suspensions, nasogastric, or buccal preparations). Recruitment was concentrated in North America and Europe, with limited participation from sub-Saharan Africa, South-East Asia, and Latin America - regions that carry a disproportionate burden of invasive fungal disease and antifungal resistance and where diagnostic and susceptibility-testing capacity is often constrained (2). None of the records described recruitment targets stratified by ethnicity or socioeconomic status, which may limit generalisability.

Encouragingly, isolated expanded-access and compassionate-use reports demonstrate feasibility and potential benefit in selected children. Michel et al. reported the first paediatric use of olorofim in a 14-year-old with X-linked chronic granulomatous disease and pan-azole-resistant Aspergillus fumigatus, achieving prolonged remission after lobectomy and therapeutic drug monitoring–guided oral therapy (25); Goggin et al. described fosmanogepix in a 14-year-old with STAT3 hyper-IgE syndrome and invasive Fusarium solani complex infection, with complete lesion resolution and no nephrotoxicity (24). Although anecdotal, these cases illustrate both the therapeutic promise and the need for structured paediatric access pathways, including dedicated trials, bridging studies, and post-marketing surveillance.

7 New action plan – accelerating antifungal research in paediatrics: a call to action and recommendations

Closing the evidence gap in paediatric antifungal therapy, particularly in the era of escalating antifungal resistance (AFR) requires coordinated, multi-sector action. While adult data can offer an initial foundation, the metabolic, immunologic, and developmental differences in children, and especially neonates, necessitate targeted safety and PK/PD studies to achieve regulatory approval and optimal clinical outcomes. It is important to note that unlike bacterial infections, there is no vaccine available for prevention, underlining the urgency for effective antifungal therapeutic tools.

It is worth mentioning at this point that the tools needed to protect paediatric interests in drug development largely exist already: the EMA Paediatric Regulation and its paediatric investigation plans, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act in the United States, the WHO fungal priority pathogens list and its accompanying research agenda, and the operating models built by paediatric trial networks such as c4c and EPMyN. What has been missing is their application to antifungal agents and to the neonatal and paediatric populations carrying the greatest burden of resistance. Three things therefore distinguish what we propose from the generic paediatric instruments on which it draws. It is antifungal-specific, and its recommendations are written for agents whose diagnostic, dosing and formulation problems differ from those of antibacterials. It treats surveillance, diagnostic capacity, formulation development and trial design as a single dependent chain rather than as parallel workstreams, on the reasoning that a validated paediatric dose is of little use where the infection cannot be diagnosed or the drug cannot be administered. And it is weighted deliberately towards high-burden, low-resource settings, where the interval between a first approval and actual availability is longest. We therefore propose urgent adoption of an AMR–AFR paediatric ACCELERATE framework to guide policy, research, and regulatory strategies (Figure 1):

• Awareness: Expand global education initiatives to emphasise the burden of paediatric IFDs and the rising threat of AFR. Embed paediatric-specific endpoints into AMR/AFR surveillance dashboards, integrate paediatric burden into fungal disease modelling, and engage national and international stakeholders including World Health Organization (WHO), the European Medicines Agency (EMA), Food and Drug Administration (FDA) to align strategic priorities.
• Clinical trials: Prioritise early inclusion of paediatric cohorts in antifungal development programs, employing bridging strategies from adult data where appropriate. Adaptive platform trials should integrate paediatric arms from inception, enabling iterative PK/PD-informed dosing adjustments. Strengthening regional trial networks, particularly in LMICs, will improve equitable access and representation, with engagement from established paediatric consortia.
• Formulation: Invest in child-appropriate pharmaceutical development, including dispersible tablets, buccal films, nasogastric-compatible suspensions, and dosing schemes adapted to weight and maturation status. Regulatory authorities should require PIPs alongside adult protocols to ensure parallel formulation development.
• Public Health Surveillance and Diagnostics: Access and availability of diagnostic techniques and susceptibility testing for LMIC, establishing a referral laboratory within one country or city, especially for difficult-to-diagnose IFDs. Cross-border public health surveillance should be strengthened for all age groups, including infants and children. Ideally, this would go along with improved diagnostic (including resistance detection) capabilities and secure modes of data exchange.
• Real-world data integration: Harness registries to capture paediatric IFI cases treated with novel antifungals, including under compassionate use or expanded access. Linking these datasets with PK/PD sampling, and adverse event reporting will accelerate early signal detection for safety and efficacy. Data-sharing agreements between clinical networks, academia, and industry are essential to maximise utility.
• Regulatory and industry engagement: Create formal mechanisms for early dialogue between paediatric networks, regulators (WHO, EMA, FDA), and industry groups (e.g., EFPIA) to define accelerated access pathways. Potential approaches include rolling submission of paediatric PK/safety data, conditional authorisations based on bridging evidence, and mandatory post-authorisation paediatric safety commitments.
• Equity and representation: Ensure paediatric antifungal studies are geographically and demographically representative of the global IFI burden. Site development and trial capacity should be prioritised in underrepresented high-burden regions such as sub-Saharan Africa, Southeast Asia, and Latin America. Representation should include both trial enrolment and post-approval access in high-burden regions.
• Artificial intelligence (AI) and emerging technologies: AI and advanced analytics can play a transformative role in bridging paediatric data gaps in antifungal R&D (51). AI-driven population PK/PD modelling can optimise dose selection for neonates and children based on sparse sampling, reducing trial size requirements. Machine learning algorithms applied to large-scale real-world datasets can identify early safety signals, predict resistance patterns, and stratify patient risk. Natural language processing (NLP) tools can accelerate literature synthesis and case identification, while digital trial platforms can enhance recruitment and retention in geographically dispersed paediatric cohorts. AI-enabled simulation environments may also inform adaptive trial designs and regulatory decision-making.

These opportunities are real, but they are bounded by the data that exist. Paediatric antifungal datasets are small, sparsely sampled and markedly heterogeneous, differing between sources in age banding, case definitions, diagnostic and susceptibility-testing methods and outcome ascertainment, and that heterogeneity is the principal obstacle to machine-learning approaches: models trained on so few and so variable records tend to overfit and to yield unstable estimates that look convincing in development and fail on new data. Several consequences follow. Because the available records derive disproportionately from high-income settings and from older children, any model inherits that bias and cannot be assumed to transfer to neonates or to LMIC populations without evidence that it does. Internal validation with pre-specified performance metrics and calibration is therefore a minimum rather than a sufficient standard, and independent external validation in populations, settings and time periods distinct from those used in training should be expected before a model is described as useful. Where a model informs a dose or a risk estimate, clinicians and regulators need to be able to interrogate how it reached that output rather than simply accept it, which places a practical premium on explainability. Governance matters equally, since paediatric records are sensitive and frequently cannot be pooled across jurisdictions, so that federated or otherwise privacy-preserving analysis is likely to be the realistic route to adequate sample size. Regulatory acceptance will in turn depend on alignment with the emerging EMA and FDA positions on artificial intelligence in medicines development, and on prospective rather than retrospective evaluation. Until these conditions are met, artificial intelligence is best understood as a means of prioritising and designing paediatric studies, not as a substitute for conducting them.

In parallel, global academic and clinical stakeholders should advocate for policy changes that align paediatric antifungal research timelines with adult development programs, avoiding multi-year delays in access. Expanded-access initiatives should be structured to include children when clinically justified, supported by adaptive risk–benefit frameworks and real-time PK/PD-informed dosing guidance. Without decisive action, the widening lag in paediatric antifungal evidence risks leaving vulnerable populations without effective options in the face of rising AFR. By accelerating targeted clinical trials, integrating real-world evidence, leveraging AI-powered analytics, and connecting paediatric research networks to regulatory and industry partners, a sustainable and equitable pathway can be established to bring antifungal innovation to the children and neonates who need it most.

8 Discussion

Despite substantial progress in antifungal drug discovery, paediatric populations, particularly those in low-resource settings and regions with a high burden of AFR, remain disproportionately excluded from the benefits of therapeutic innovation. This review identifies a persistent misalignment between current drug development trajectories and the clinical realities of vulnerable children. While individual compassionate-use experiences demonstrate that investigational agents such as fosmanogepix and olorofim can be administered safely to adolescents, these isolated cases do not compensate for the broader deficits in paediatric-specific clinical data. The continued absence of age-appropriate formulations, validated paediatric dosing regimens, and inclusive, geographically representative trial enrolment underscores a systemic failure in equitable drug access.

Addressing these deficiencies will require coordinated, cross-sector action. Implementation of a structured approach such as the AMR–AFR paediatric ACCELERATE framework offers a pragmatic pathway to re-centre paediatric needs within antifungal research and development pipelines. This includes enhancing awareness of paediatric IFD burden, mandating inclusive and adaptive trial designs, incentivising development of child-appropriate formulations, and integrating real-world evidence from global registries to inform safety and PK/PD bridging. Policymakers, regulatory bodies, funding agencies, and pharmaceutical developers must collectively prioritise these measures. Without such alignment, the most fragile patients, immunocompromised children and neonates, will remain at risk of treatment delays, reliance on off-label regimens, and preventable morbidity and mortality as fungal threats intensify worldwide.

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Footnotes

Edited by: María Guadalupe Frías De León, Hospital Regional de Alta Especialidad de Ixtapaluca, Mexico

Reviewed by: Muneer Ahmed Qazi, Shah Abdul Latif University, Pakistan

Conrad Achilonu, Mayo Clinic, United States