Evidence mapPaperPMID 41831196Full record

Trial reportAging clinical and experimental research2026

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

Angela M Abbatecola, Silvia Travaglini, Claudio Pedone, Alba Malara, Andrea Berti, Maria Teresa Vigliotta, Rosanna Pullia, Daniele Elmi, Valerio Alex Ippolito, Raffaele Antonelli Incalzi

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Aging clinical and experimental research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Angela M AbbatecolaDepartment of Life Sciences, Health, and Health Professions, Link Campus University, Rome, Italy.ORCID http://orcid.org/0000-0001-5522-9257
Silvia TravagliniOperative Research Unit of Geriatrics, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.
Claudio PedoneOperative Research Unit of Geriatrics, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.ORCID http://orcid.org/0000-0003-1847-9032
Alba MalaraANASTE Humanitas Foundation, Rome, Italy.ORCID http://orcid.org/0000-0003-0073-3792
Andrea BertiCasa di Cura Villa Immacolata, Provincia Romana Camilliani, Rome, Italy.
Maria Teresa VigliottaRSA San Germano, Piedimonte, FR, Italy.ORCID http://orcid.org/0009-0003-0997-6501
Rosanna PulliaRSA San Domenico, Lamezia Terme, RSA Villa Elisabetta, Cortale, CZ, Italy.ORCID http://orcid.org/0009-0008-3126-0223
Daniele ElmiCasa di Cura Villa Immacolata, Provincia Romana Camilliani, Rome, Italy.ORCID http://orcid.org/0009-0006-9846-5296
Valerio Alex IppolitoRSA Villa Azzurra, Roseto Capo Spulico, CS, Italy.ORCID http://orcid.org/0009-0001-5186-9334
Raffaele Antonelli IncalziResearch Unit of Geriatrics, Università Campus Bio-Medico di, Rome, Italy. r.antonelli@policlinicocampus.it.ORCID http://orcid.org/0000-0003-2100-2075

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

aimsOur 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.

methods13 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).

results272 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.

conclusionsThis 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.

Indexed as

Cell ExtractsRespiratory Tract InfectionsAgedAged, 80 and overBacterial LysatesDouble-Blind MethodFemaleGeriatric AssessmentHumansMaleNursing Home ResidentsNursing HomesBacterial LysatesBroncho-VaxomCell ExtractsNursing home careOlder personsOM-85Randomized clinical drug trialRespiratory tract infections

Identifiers

PMID41831196
PMCPMC13013249

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.