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Recruiting

NCT Number: NCT07030673

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

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, 80054, France

Location status: Recruiting

Location contact

Jean-Philippe Lanoix, PR

CONTACT

[email protected]

33+322668813

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

antibiotic withdrawal

Drug

stop antibiotics on viral or negative results

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

Primary outcomes

  1. Number of days without antibiotics

    Time frame: day 30

Secondary outcomes

  1. number of side effects of antibiotics

    Time frame: day 30

  2. Mortality at M1

    Time frame: day 30

  3. martality at day 180

    Time frame: day 180

  4. Length of hospitalization in acute care

    Time frame: day 30

    Length of hospitalization in acute care (days)

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Philippe LANOIX, Pr

CONTACT

[email protected]

33+32668813

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • CH SOISSONS
  • Centre Hospitalier Roubaix
  • Centre Hospitalier de Beauvais
  • Hôpital Les Bateliers, CHU de Lille
  • Tourcoing Hospital
  • University Hospital, Caen
  • University Hospital, Rouen

Registry information

Acronym: ABUSIV

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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