drugset / Trial / NCT01232595
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
RandomizedParallel-groupSingle-blindTreatment
Summary
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.
Timeline
- Start
- 2010-10
- Primary completion
- 2013-07
- Completion
- 2013-07
Publications
- Mullane K, Lee C, Bressler A, Buitrago M, Weiss K, Dabovic K, Praestgaard J, Leeds JA, Blais J, Pertel P. Multicenter, randomized clinical trial to compare the safety and efficacy of LFF571 and vancomycin for Clostridium difficile infections. Antimicrob Agents Chemother. 2015 Mar;59(3):1435-40. doi: 10.1128/AAC.04251-14. Epub 2014 Dec 22.
- Bhansali SG, Mullane K, Ting LS, Leeds JA, Dabovic K, Praestgaard J, Pertel P. Pharmacokinetics of LFF571 and vancomycin in patients with moderate Clostridium difficile infections. Antimicrob Agents Chemother. 2015 Mar;59(3):1441-5. doi: 10.1128/AAC.04252-14. Epub 2014 Dec 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LFF571 | Peptide | 200 mg | Oral |
| Comparator | Vancomycin | Other / unclassified | 125 mg | — |