C diff quik chek complete

Ridinilazole (200 mg) was given orally twice daily for 10 days, with participants also receiving two doses of placebo to preserve blinding through consistency with the dosing schedule in the vancomycin group, while vancomycin (125 mg) was given orally four times daily for 10 days. Use of other antibiotics to treat C difficile infection was prohibited, as were probiotics, antidiarrhoeal drugs, antiperistaltic drugs, and other products used to slow bowel movement. The first dose of study medication was administered following completion of screening procedures, baseline assessments, and randomisation (appendix). As part of the baseline assessments, stool samples were assessed for the presence of free C difficile toxin with either an enzyme immunoassay test (C. Diff Quik Chek Complete; Alere, Waltham, MA, USA) provided by the sponsor to each site or a cell cytotoxicity neutralisation assay at a central laboratory (South Bend Medical Foundation, South Bend, IN, USA). Participants were assessed for clinical response to treatment on day 4–6, at the end of treatment (day 10–11), at test of cure (day 12–14), at weekly follow-up visits after completion of treatment (day 13–39), at a follow-up site visit (day 22–28), and at an end-of-study visit (day 37–43). In addition, unscheduled visits could be made if recurrence was suspected.

Diagnosis of CDI was based on current recommendations, using a two-step algorithm with a combined test of GDH and toxins (C. DIFF QUIK CHEK COMPLETE^®, Alere, Waltham, MA, USA) followed by PCR (GeneXpert^® Systems, Cepheid, Sunnyvale, CA, USA) in cases of non-contributing result.
For a GDH-positive sample, quantitative culture was performed. At least 3 colonies by culture were characterized at the National Reference Center (NRC) by PCR multiplex detection of tcdA, tcdB, tpi, tcdC, cdtA, cdtB genes and PCR ribotyping [24 (link),25 (link)].