Tag Archives: metronidazole

Clostridium difficile Treatment Strategies

Authors: Teena Chopra, Ellie J.C. Goldstein, Sherwood L. Gorbach

  • First published: 20 December 2016 Full publication history
  • DOI: 10.1002/phar.1863View/save citation
  • Funding: This work was supported by Merck & Co., Inc., Kenilworth, New Jersey.
  • Disclosures: T.C. served as a speaker for Pfizer Inc., Merck & Co., Inc., Cubist Pharmaceuticals, Inc., and Actavis, plc. E.J.C.G. has participated in advisory boards sponsored by Merck & Co., Inc., Cubist Pharmaceuticals, Inc., Optimer Pharmaceuticals, Inc., Bayer AG, Bio-K Plus International, Inc., Summit Therapeutics, plc, Kindred Healthcare, Inc., Novartis Pharmaceuticals Corporation, Daiichi Sankyo Company, Ltd., and Rempex Pharmaceuticals, Inc. He has served as a speaker for Bayer AG, Merck & Co., Inc., Forest Laboratories, Inc., Optimer Pharmaceuticals, Inc., and Cubist Pharmaceuticals, Inc.; he has received research grants from Merck and Co., Inc., Schering-Plough Pharmaceuticals, LLC, Optimer Pharmaceuticals, Inc., Theravance Biopharma, Cubist Pharmaceuticals, Inc., Pfizer, Inc., Astellas Pharma US, Inc., Cerexa, Inc., Forest Laboratories, Inc., Impax Laboratories, Inc., Novartis Pharmaceuticals Corporation, Clinical Microbiology Institute, Genzyme Corporation, a Sanofi company, Nano Pacific Holdings, Inc., Romark Laboratories, LC, ViroXis Corp., Warner Chilcott, plc, AvidBiotics Corp., GLSynthesis, Inc., Immunome, Inc., Salix Pharmaceuticals, Inc., Summit Therapeutics, plc, GlaxoSmithKline plc, Rempex Pharmaceuticals, Inc., Symbiomix Therapeutics, Gynuity Health Projects, Durata Therapeutics, Inc., and Toltec Pharmaceuticals, LLC. S.L.G. has served as a consultant for Seres Therapeutics, Inc., Medimmune, LLC, and Cempra Pharmaceuticals. He was also a consultant for Cubist Pharmaceuticals, now Merck & Co, Inc., at the time that the manuscript was written.


In recent years, Clostridium difficile infection (CDI) has become a global public health threat associated with increased morbidity, mortality, and economic burden, all of which are exacerbated with disease recurrence. Current guidelines informing treatment decisions are largely based on definitions of disease severity at diagnosis, with subjective components not well delineated across treatment algorithms and clinical trials. Furthermore, there is little evidence linking severity at onset to outcome. However, reducing the risk of recurrence may offer both a better outcome for the individual and decreased downstream economic impact.

The authors present data supporting the opinion that patients deemed at low risk for recurrence should receive vancomycin (or metronidazole when cost is an issue), while those at higher risk of recurrence would benefit from fidaxomicin treatment.

Although further prospective studies are needed, choosing treatment with the goal of preventing recurrent CDI may offer a better guide than disease severity.

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FDA Has Granted Appili Therapeutics Orphan Drug Designation For ATI-1501 (metronidazole) For Potential Treatment Of C. diff. Infection (CDI) In Children


“Pediatric” CDI future medication treatment option.s

Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.

ATI-1501 is a taste-masked reformulation of metronidazole. For most children, metronidazole tablet is highly unpalatable due to its bitter taste. This reformulation has the potential to improve compliance rates in children in need for a safe and effective treatment for CDI.

The company intends to initiate clinical trials for ATI-1501 by 2017.

For more information visit Appilitherapeutics.com.


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