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A study in which the blood levels of the antibiotic fidaxomicin are studied in patients with an inflammation of the intestine and concomitantly an infection of the gut caused by bacteria called Clostr...

Update Il y a 4 ans
Reference: EUCTR2014-003002-32

A study in which the blood levels of the antibiotic fidaxomicin are studied in patients with an inflammation of the intestine and concomitantly an infection of the gut caused by bacteria called Clostridium difficile

Woman and Man

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Extract

The primary objective of the study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection on Day 1, Day 5 and Day 10 of treatment.

Inclusion criteria

  • Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)

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