Secondary Analysis of a Systematic Review: Are Antifungal Noninferiority Trials at Risk of Eroding Effectiveness Because of Biocreep?
Overview
Overview
Journal
Antimicrob Agents Chemother
Publisher
American Society for Microbiology
Specialty
Pharmacology
Date
2021 Oct 18
PMID
34662190
Authors
Authors
Affiliations
Affiliations
Soon will be listed here.
Abstract
Noninferiority randomized controlled trial (RCT) effectiveness may erode when results favor the active control over time and when a decreasingly effective control arm is used in serial trials. We analyzed 32 antifungal noninferiority RCTs (NI-RCTs) for these scenarios in this secondary analysis of a systematic review. Our exploratory analysis suggests that the erosion risk in the effectiveness of antifungal noninferiority trials is uncommon. Findings are limited by small sample size and overall risk of bias.
References
1.
Rex J, Bennett J, Sugar A, Pappas P, van der Horst C, Edwards J
. A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. Candidemia Study Group and the National Institute. N Engl J Med. 1994; 331(20):1325-30.
DOI: 10.1056/NEJM199411173312001.
View
2.
Kohno S, Izumikawa K, Ogawa K, Kurashima A, Okimoto N, Amitani R
. Intravenous micafungin versus voriconazole for chronic pulmonary aspergillosis: a multicenter trial in Japan. J Infect. 2010; 61(5):410-8.
DOI: 10.1016/j.jinf.2010.08.005.
View
3.
Pappas P, Rotstein C, Betts R, Nucci M, Talwar D, De Waele J
. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2007; 45(7):883-93.
DOI: 10.1086/520980.
View
4.
Walsh T, Finberg R, Arndt C, Hiemenz J, Schwartz C, Bodensteiner D
. Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. National Institute of Allergy and Infectious Diseases Mycoses Study Group. N Engl J Med. 1999; 340(10):764-71.
DOI: 10.1056/NEJM199903113401004.
View
5.
Molloy S, Kanyama C, Heyderman R, Loyse A, Kouanfack C, Chanda D
. Antifungal Combinations for Treatment of Cryptococcal Meningitis in Africa. N Engl J Med. 2018; 378(11):1004-1017.
DOI: 10.1056/NEJMoa1710922.
View