Literature DB >> 34662190

Secondary Analysis of a Systematic Review: Are Antifungal Noninferiority Trials at Risk of Eroding Effectiveness Because of Biocreep?

Adam S Komorowski1,2, Anthony D Bai2,3, Anna Cvetkovic4, Omar Mourad4, Carson K L Lo4, Xena X Li1,4, Vaibhav Mokashi4, Aidan Findlater4, D Brody Duncan1, Charlotte Fuller1, Daniela L Leto1,4, Deborah Yamamura1,4, Dominik Mertz4.   

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.

Entities:  

Keywords:  anti-infective agents; antifungal agents; biocreep; noninferiority trials; systematic review

Mesh：

Substances：

Year:  2021        PMID： 34662190      PMCID： PMC8765287          DOI： 10.1128/AAC.01627-21

Source DB:  PubMed          Journal:  Antimicrob Agents Chemother        ISSN： 0066-4804            Impact factor:   5.938


  40 in total

1.  White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens.

Authors: 
Journal:  Clin Infect Dis       Date:  2012-08-13       Impact factor: 9.079

2.  A randomized, double blind, comparative trial of micafungin (FK463) vs. fluconazole for the treatment of oesophageal candidiasis.

Authors:  N T E de Wet; A J Bester; J J Viljoen; F Filho; J M Suleiman; E Ticona; E A Llanos; C Fisco; W Lau; D Buell
Journal:  Aliment Pharmacol Ther       Date:  2005-04-01       Impact factor: 8.171

3.  Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial.

Authors:  Johan A Maertens; Issam I Raad; Kieren A Marr; Thomas F Patterson; Dimitrios P Kontoyiannis; Oliver A Cornely; Eric J Bow; Galia Rahav; Dionysios Neofytos; Mickael Aoun; John W Baddley; Michael Giladi; Werner J Heinz; Raoul Herbrecht; William Hope; Meinolf Karthaus; Dong-Gun Lee; Olivier Lortholary; Vicki A Morrison; Ilana Oren; Dominik Selleslag; Shmuel Shoham; George R Thompson; Misun Lee; Rochelle M Maher; Anne-Hortense Schmitt-Hoffmann; Bernhardt Zeiher; Andrew J Ullmann
Journal:  Lancet       Date:  2015-12-10       Impact factor: 79.321

4.  Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. National Institute of Allergy and Infectious Diseases Mycoses Study Group.

Authors:  T J Walsh; R W Finberg; C Arndt; J Hiemenz; C Schwartz; D Bodensteiner; P Pappas; N Seibel; R N Greenberg; S Dummer; M Schuster; J S Holcenberg
Journal:  N Engl J Med       Date:  1999-03-11       Impact factor: 91.245

5.  Intravenous micafungin versus voriconazole for chronic pulmonary aspergillosis: a multicenter trial in Japan.

Authors:  Shigeru Kohno; Koichi Izumikawa; Kenji Ogawa; Atsuyuki Kurashima; Niro Okimoto; Ryoichi Amitani; Hiroshi Kakeya; Yoshihito Niki; Yoshitsugu Miyazaki
Journal:  J Infect       Date:  2010-08-24       Impact factor: 6.072

6.  Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial.

Authors:  Flavio Queiroz-Telles; Eitan Berezin; Guy Leverger; Antonio Freire; Annalie van der Vyver; Tawee Chotpitayasunondh; Josip Konja; Heike Diekmann-Berndt; Sonja Koblinger; Andreas H Groll; Antonio Arrieta
Journal:  Pediatr Infect Dis J       Date:  2008-09       Impact factor: 2.129

7.  Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis.

Authors:  Peter G Pappas; Coleman M F Rotstein; Robert F Betts; Marcio Nucci; Deepak Talwar; Jan J De Waele; Jose A Vazquez; Bertrand F Dupont; David L Horn; Luis Ostrosky-Zeichner; Annette C Reboli; Byungse Suh; Raghunadharao Digumarti; Chunzhang Wu; Laura L Kovanda; Leah J Arnold; Donald N Buell
Journal:  Clin Infect Dis       Date:  2007-08-29       Impact factor: 9.079

8.  A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. Candidemia Study Group and the National Institute.

Authors:  J H Rex; J E Bennett; A M Sugar; P G Pappas; C M van der Horst; J E Edwards; R G Washburn; W M Scheld; A W Karchmer; A P Dine
Journal:  N Engl J Med       Date:  1994-11-17       Impact factor: 91.245

9.  Antifungal Combinations for Treatment of Cryptococcal Meningitis in Africa.

Authors:  Síle F Molloy; Cecilia Kanyama; Robert S Heyderman; Angela Loyse; Charles Kouanfack; Duncan Chanda; Sayoki Mfinanga; Elvis Temfack; Shabir Lakhi; Sokoine Lesikari; Adrienne K Chan; Neil Stone; Newton Kalata; Natasha Karunaharan; Kate Gaskell; Mary Peirse; Jayne Ellis; Chimwemwe Chawinga; Sandrine Lontsi; Jean-Gilbert Ndong; Philip Bright; Duncan Lupiya; Tao Chen; John Bradley; Jack Adams; Charles van der Horst; Joep J van Oosterhout; Victor Sini; Yacouba N Mapoure; Peter Mwaba; Tihana Bicanic; David G Lalloo; Duolao Wang; Mina C Hosseinipour; Olivier Lortholary; Shabbar Jaffar; Thomas S Harrison
Journal:  N Engl J Med       Date:  2018-03-15       Impact factor: 91.245

10.  Intravenous itraconazole compared with liposomal amphotericin B as empirical antifungal therapy in patients with neutropaenia and persistent fever.

Authors:  Isao Yoshida; Akiko M Saito; Shiro Tanaka; Ilseung Choi; Michihiro Hidaka; Yasuhiko Miyata; Yoshiko Inoue; Satoshi Yamasaki; Toshiya Kagoo; Hiroatsu Iida; Hiromasa Niimi; Takuya Komeno; Chikamasa Yoshida; Fumihito Tajima; Hideyuki Yamamoto; Ken Takase; Hironori Ueno; Takeshi Shimomura; Tatsunori Sakai; Yasuhiro Nakashima; Chikashi Yoshida; Shiro Kubonishi; Kazutaka Sunami; Shinichiro Yoshida; Aki Sakurai; Yukihiro Kaneko; Yoshitsugu Miyazaki; Hirokazu Nagai
Journal:  Mycoses       Date:  2020-05-28       Impact factor: 4.377
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