Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07030673

Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-01-16

256

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

U

University Hospital, Rouen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying antibiotic use in elderly patients hospitalized with viral respiratory infections such as influenza, parainfluenza, RSV, and SARS-CoV-2. These infections carry a high risk of mortality, especially when complicated by bacterial co-infections, which significantly increase death risk. The study aims to provide strong evidence on whether stopping antibiotics early in viral infections is safe or potentially harmful, addressing the common overuse of antibiotics in these cases. Participants are assigned to one of two groups: one where antibiotics are stopped early based on viral or negative test results, and a standard care group where antibiotics are given as usual. The standard antibiotics include Amoxicillin-clavulanic acid, Ceftriaxone, Piperacillin-Tazobactam, or Pristinamycin, each administered for seven days with specified doses. The study begins with hospitalization and microbiological testing within 48 hours and monitors patients during their hospital stay. Throughout the study, researchers track the number of days patients go without antibiotics over 30 days, antibiotic side effects, mortality at 30 and 180 days, and length of hospital stay. Patient consent is required, and evaluations include clinical signs, imaging tests, and microbiological samples. The total participation may extend up to six months for mortality follow-up, ensuring comprehensive safety and outcome monitoring.

CONDITIONS

Brief Title

Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 65 years or older
  • Affiliated to a social security scheme
  • Hospitalized for a lower respiratory infection defined by at least 2 of the following signs: fever over 38°C, high or low white blood cell count (≥12000 or ≤4000), purulent secretions, or abnormal lung sounds indicating damage
  • Presence of a pulmonary image on X-ray, CT scan, or ultrasound
  • Microbiological diagnostic sample taken within 48 hours of admission
  • Patient or representative provides informed consent
Not Eligible

You will not qualify if you...

  • Hospitalization planned for less than 48 hours or transfer to another center within 7 days
  • Patient in septic shock
  • Febrile aplasia
  • No microbiological sampling within 48 hours after admission
  • Moribund patient or death expected within one week
  • Proven inhalation injury by endoscopy or eyewitness
  • Presence of purulent pleurisy, lung abscess, or other bacterial infection requiring antibiotics

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 days

Participants receive antibiotic therapy or undergo early discontinuation of antibiotics based on viral or negative test results.

Daily visits during antibiotic therapy

Follow-up

Duration - Up to 6 months

Participants are monitored for side effects, mortality, and length of hospitalization after treatment ends.

Visits at 1 month and 6 months post-treatment

Trial Site Locations

Total: 1 location

1

CHRU Amiens

Amiens, France, 80054

Actively Recruiting

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Research Team

J

Jean-Philippe LANOIX, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Frequently Asked Questions

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