ArticleThe Journal of antimicrobial chemotherapy2022
Reason and reality-identifying barriers to patient enrolment for clinical trials in invasive candidiasis.
Article in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 2 papers.
What it found
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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.
A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment
A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Invasive candidiasis in intensive care medicine: shaping the future of diagnosis and therapy.Intensive care medicine · 2025Review
- The effectiveness and safety of posaconazole enteric-coated tablet versus oral suspension in invasive fungal infections.Scientific reports · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesEnrolment of subjects to clinical trials investigating novel drugs for infectious diseases is an ongoing challenge. In this study, we evaluate factors associated with non-enrolment in treatment trials for invasive candidiasis.
methodsWe conducted a retrospective review of pre-screening logs of patients that were assessed for enrolment in the three clinical trials ACTIVE (NCT00413218), APX001-201 (NCT03604705) and ReSTORE (NCT03667690), investigating novel drugs for invasive candidiasis between September 2007 and August 2021 to identify reasons for study ineligibility.
resultsTwo hundred and fifty-six patients with invasive candidiasis were identified for potential study participation with n = 154 for the ACTIVE trial, n = 89 for APX001-201 and n = 13 for ReSTORE. Half of the potential participants were unable or unwilling to consent. We further identified comorbid conditions such as hepatic or renal impairment [21 hepatic and renal cases (13.6%) in ACTIVE; 12 hepatic (13.5%) and 28 renal cases (31.5%) in APX], prior antifungal treatment [11 cases (7.1%) in ACTIVE; 16 (18.0%) in APX; 7 (38.5%) in ReSTORE] and the last positive culture obtained ≥96 h prior to dosing [1 case (0.6%) in ACTIVE; 7 (7.9%) in APX; 5 (38.5%) in ReSTORE] as relevant reasons for non-enrolment. We also identified criteria repetitively used in the analysed studies that did not contribute substantially to ineligibility rates. Ultimately, 254/256 patients (99.2%) were ineligible for enrolment in the respective trial.
conclusionsThis study identified barriers to enrolment in clinical trials assessing novel antifungal agents in invasive candidiasis. Identification of eligibility criteria associated with non-enrolment allows modification of future trial designs and may ultimately result in higher recruitment rates.
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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.