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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 65 years affiliated to a social security scheme

hyperthermia >38°C,

hyperleukocytosis ≥12000 or ≤4000,

purulent aspirations/sputum,

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: stop antibioticExperimental treatment 1 intervention
Group B: standard of careActive comparator 1 intervention

Trial outcomes

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

Length of hospitalization in acute care (days)

Time frame
day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

University Hospital, Rouen

Collaborator

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