NCT06655272

Brief Summary

People living in NH are at higher risk of respiratory infections compared to their counterpart living in the community. Products obtained from dead bacteria ("bacterial lysate") can be used to boost immune system and may reduce the risk of respiratory infections. Very little information is available on the effect of these substances in older people. This study will evaluate the efficacy of a bacterial lysate in reducing the incidence of lower respiratory tract infections in older people living in nursing homes. The study will include a treatment arm, in which participants will received the lysate, and a control arm in which participants will received a matching placebo (i.e., a pill that has the same appearance of the lysate but does not contain the lysate itself).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

October 22, 2024

Last Update Submit

March 14, 2025

Conditions

Respiratory Tract Infections (RTI)

Keywords

Older peopleNursing homeBacterial lysate

Outcome Measures

Primary Outcomes (1)

  • Incidence of lower respiratory tract infections.

    New cases of clinically-diagnosed lower respiratory tract infections

    12 months

Secondary Outcomes (1)

  • Rate of hospitalizations and emergency room admissions

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Bacterial lysate p.o. administered for two three-months cycles.

Drug: Bacterial Lysate

Control

PLACEBO COMPARATOR

Matching placebo.

Drug: Placebo

Interventions

Bacterial LysateDRUG

Administration p.o. for 10 days per month for 3 months, two consecutive cycles.

Intervention
PlaceboDRUG

Matching placebo.

Control

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 75 years or older
  • At least 2 RTIs in the year prior to enrollment
  • Patients must have been residing in nursing homes for at least 6 months and have an estimated length of stay in nursing homes of at least 6 months by their treating physician.
  • Signed informed consent. If participants are unable to provide informed consent due to cognitive impairment, consent will be provided by a legally recognized representative or trustee of the patient (pursuant to Article 4 of Law No. 219 of December 22, 2017).
  • Have a life expectancy of at least one year in the judgment of their treating physician.

You may not qualify if:

  • Patients with known allergy or previous intolerance to any component (including the excipient) of the study drug
  • Patients with active neoplasia and prognosis of less than one year
  • Patients with previous organ transplantation
  • Patients treated with prohibited drugs (see Table 1) in the 3 months prior to the start of the study
  • Patients who have taken bacterial lysates in the 6 months prior to enrollment or are currently using them
  • Patients regularly treated with oral corticosteroids
  • Patients unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements)
  • Patients with any other clinical condition that, in the opinion of the investigator, would not allow completion of the protocol and safe administration of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Campus Bio-Medico

Roma, RM, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Central Study Contacts

Silvia Travaglini, MD

CONTACT

+39 06 22541silvia.travaglini@unicampus.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 23, 2024

Study Start

February 1, 2025

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)