Universität zu Köln

Sprute, Rosanne ORCID: 0000-0003-2457-6437, Grothe, Jan H., Heringer, Sarah ORCID: 0000-0001-7680-0344 and Cornely, Oliver A. ORCID: 0000-0001-9599-3137 (2022). Reason and reality-identifying barriers to patient enrolment for clinical trials in invasive candidiasis. J. Antimicrob. Chemother., 77 (12). S. 3475 - 3482. OXFORD: OXFORD UNIV PRESS. ISSN 1460-2091

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Abstract

Objectives Enrolment 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. Methods We 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. Results Two 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. Conclusions This 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Sprute, Rosanne UNSPECIFIED orcid.org/0000-0003-2457-6437 UNSPECIFIED Grothe, Jan H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heringer, Sarah UNSPECIFIED orcid.org/0000-0001-7680-0344 UNSPECIFIED Cornely, Oliver A. UNSPECIFIED orcid.org/0000-0001-9599-3137 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-671307
DOI:	10.1093/jac/dkac344
Journal or Publication Title:	J. Antimicrob. Chemother.
Volume:	77
Number:	12
Page Range:	S. 3475 - 3482
Date:	2022
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	1460-2091
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language INFECTIONS; MANAGEMENT; CANDIDEMIA; GUIDELINE; CANCER Multiple languages Infectious Diseases; Microbiology; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/67130