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

Randomized clinical drug trials (RCT) in older adults remain limited due to procedural complexity related to multimorbidity, frailty and disabilities. 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. 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). 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. 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. 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.