Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: antibiotic withdrawal, Antibiotics.
- Who it may be relevant to
- Registry conditions: Elderly, Antibiotics Overuse, Viral Infections, PCR Multiplex. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug antibiotic withdrawal
stop antibiotics on viral or negative results - Drug Antibiotics
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 outcome measures
- Number of days without antibiotics [Time frame: day 30]
Secondary outcome measures (4)
- number of side effects of antibiotics [Time frame: day 30]
- Mortality at M1 [Time frame: day 30]
- martality at day 180 [Time frame: day 180]
- Length of hospitalization in acute care [Time frame: day 30]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHRU Amiens — Amiens
Identifiers
NCT: NCT07030673 · PI2023_843_0153