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

NCT07030673 | Recruiting DMC

• 1 other identifier: PI2023_843_0153
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Among winter respiratory viruses, influenza is the most common and therefore responsible for the highest mortality, but parainfluenza and RSV viruses have an even higher risk of mortality (1.6 to 1.9 times), this toll being paid mainly by the elderly and co-morbid population. Futhermore, SARS-Cov2 will probably become endemic and/or epidemic with the same targets of fragile patients. These viral infections are serious, however a bacterial co-infection worsens the prognosis even more: excess risk of mortality = 2.6, 95% CI \[1.9-3.7\]. Although rare, these co-infections are the subject of a prescription of antibiotics in more than 50% of influenza infections or other serious viral infections. Mainly due to this excess risk of mortality associated with the difficulty of diagnosing these co-infections. Proper antibiotic use requires preventing this misuse and its harmful consequences in the short and long term at all costs. It is therefore imperative to have solid (grade A) evidence showing that antibiotic therapy in viral infections is not only futile but also potentially harmful.

Conditions

Elderly; Antibiotics Overuse; Viral Infections; PCR Multiplex

Keywords

viral infections; elderly; antibiotics overuse; PCR multiplex

Outcome Measures

Primary Outcomes (1)

• Number of days without antibiotics

  day 30

Secondary Outcomes (4)

• number of side effects of antibiotics

  day 30

• Mortality at M1

  day 30

• martality at day 180

  day 180

• Length of hospitalization in acute care

  day 30

Study Arms (2)

stop antibiotic

EXPERIMENTAL

Drug: antibiotic withdrawal

standard of care

ACTIVE COMPARATOR

Drug: Antibiotics

Interventions

antibiotic withdrawal DRUG

stop antibiotics on viral or negative results

stop antibiotic

Antibiotics DRUG

standard of care Antibiotics are : Amoxicilline-acide clavulanique : 1g x3/j, 7j or Ceftriaxone : 1g/j, 7j or Pipéracilline-Tazobactam : 4g x3/j, 7j or Pristinamycine : 1g x 3/j, 7j

standard of care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients ≥ 65 years affiliated to a social security scheme
• Hospitalized for a lower respiratory infection defined as:
• the presence of 2 of the following 4 signs:
• hyperthermia \>38°C,
• hyperleukocytosis ≥12000 or ≤4000,
• purulent aspirations/sputum,
• rales on pulmonary auscultation indicating parenchymal damage
• associated with a pulmonary image (standard X-ray, CT scan or ultrasound)
• Microbiological diagnostic sample taken within 48 hours
• Informed consent of the patient or their representative

You may not qualify if:

• Hospitalization planned for \< 48 hours or transfer planned to another center within 7 days
• Patient in septic shock,
• Febrile aplasia
• Absence of diagnostic microbiological sampling (\> 48 hours after admission)
• Moribund patient,
• Death expected within the week
• Inhalation proven by endoscopy or eyewitness
• Purulent pleurisy, lung abscess, or other concomitant bacterial infection requiring antibiotic therapy.

Sponsors & Collaborators

• University Hospital, Rouen: collaborator
• Centre Hospitalier Universitaire, Amiens: lead
• Centre Hospitalier de Beauvais: collaborator
• University Hospital, Caen: collaborator
• Hôpital Les Bateliers, CHU de Lille: collaborator
• Centre Hospitalier Roubaix: collaborator
• CH SOISSONS: collaborator
• Tourcoing Hospital: collaborator

Study Sites (1)

CHRU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Jean-Philippe LANOIX, Pr

CONTACT

33+32668813; lanoix.jean-philippe@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: June 22, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)