Decentralized example of a randomized clinical trial: OM-85 use in older patients at risk of respiratory tract...

BACKGROUND: Randomized clinical drug trials (RCT) in older adults remain limited due to procedural complexity related to multimorbidity, frailty and disabilities. AIMS: Our study investigates the safety and efficacy of OM-85 in Nursing Home (NH) residents aged 75 years or older at an increased risk of respiratory tract infections (RTIs). We employ a decentralized, randomized, double-blind, and placebo-controlled Phase IV clinical trial. METHODS: 13 NHs that previously participated in the GeroCovid Vax initiatives are involved. The protocol plans to recruit up to 360 NH residents with a documented history of at least two RTIs in 12 months preceding enrollment. A 6-month treatment phase with OM-85 is ongoing. Participants, allocated according to 1:1 randomization, receive either OM-85 (7 mg) or placebo treatment (one capsule) daily for the first 10 days of 6 consecutive months. Comprehensive geriatric assessment is performed at baseline and every 3 months for 12 months (6 months of treatment, 6 months of observation). RESULTS: 272 participants are currently enrolled (30.9% men, 69.1% women) with a mean age of 84.8 ± 7.1 years, a high burden of multimorbidity (4.8 ± 2.2), polypharmacy (6.9 ± 3.4) and disability (ADL = 1.4 ± 1.5). Enrollment is still active. DISCUSSION: This RCT, the first study in NH residents aged 75 years with an increased risk of RTIs, will provide additional evidence for the use of OM-85 in a growing frail population that is underrepresented in clinical research. CONCLUSIONS: This trial highlights key methodological challenges and opportunities associated with conducting RCT drug trials in long-term care facilities, offering valuable insights for the design and implementation of future trials in this complex setting.