Prevalence of Comorbid Factors in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Randomized Trial of an Oral Microbiota-Based Therapeutic.

BACKGROUND: Although comorbidities are risk factors for recurrent Clostridioides difficile infection (rCDI), many clinical trials exclude patients with medical conditions such as malignancy or immunosuppression. In a phase 3, double-blind, placebo-controlled, randomized trial (ECOSPOR III), fecal microbiota spores, live (VOWST, Seres Therapeutics; hereafter "VOS," formerly SER-109), an oral microbiota therapeutic, significantly reduced the risk of rCDI at week 8. We evaluated the efficacy of VOS compared with placebo in patients with comorbidities and other risk factors for rCDI. METHODS: Adults with rCDI were randomized to receive VOS or placebo (4 capsules daily for 3 days) following standard-of-care antibiotics. In this post hoc analysis, the rate of rCDI through week 8 was assessed in VOS-treated participants compared with placebo for subgroups including (i) Charlson comorbidity index (CCI) score category (0, 1-2, 3-4, ≥5); (ii) baseline creatinine clearance (<30, 30-50, >50 to 80, or >80 mL/minute); (iii) number of CDI episodes, inclusive of the qualifying episode (3 and ≥4); (iv) exposure to non-CDI-targeted antibiotics after dosing; and (v) acid-suppressing medication use at baseline. RESULTS: Of 281 participants screened, 182 were randomized (59.9% female; mean age, 65.5 years). Comorbidities were common with a mean overall baseline age-adjusted CCI score of 4.1 (4.1 in the VOS arm and 4.2 in the placebo arm). Across all subgroups analyzed, VOS-treated participants had a lower relative risk of recurrence compared with placebo. CONCLUSIONS: In this post hoc analysis, VOS reduced the risk of rCDI compared with placebo, regardless of baseline characteristics, concomitant medications, or comorbidities.

The challenge of cross-cultural collaborative research: lessons learnt from a pilot case-crossover study of severe occupational hand trauma in the People's Republic of China.

OBJECTIVE: A pilot epidemiologic study was conducted in the People's Republic of China to assess the feasibility of applying the study protocol from a US case-crossover study on transient work-related exposures and the risk of an acute occupational hand injury. DESIGN: Injured workers were recruited from a hand surgery center in Ningbo, Zhejiang, People's Republic of China. A structured face-to-face interview questionnaire was administered. RESULTS: 156 workers with hand injury completed the study (73% men). The enrollment rate was 91%. Of those who refused participation, most indicated their reluctance was due to the requirement to sign the written consent form. Considerable variability was found among interviewers in ascertaining responses from participants to important exposure questions (21.3% v 97%). CONCLUSIONS: Recommendations include the following: (1) exploring effective oral-consent protocols that reduce participant concern and still meet human participant protection requirements; (2) using non-physician interviewers; and (3) increasing the intensity and standardization of interviewer training.