ElderlyABUSIVNCT07030673
Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection
A study testing antibiotic withdrawal and Antibiotics in people with Elderly and Antibiotics Overuse, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly, Antibiotics Overuse, Viral Infections
- What is being tested?
- antibiotic withdrawal and Antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens, 80054
Jean-Philippe Lanoix, PR, 33+322668813, lanoix.jean-philippe@chu-amiens.fr
About this study
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
- Being tested
- antibiotic withdrawal, Antibiotics
- Keywords
- viral infections, elderly, antibiotics overuse, PCR multiplex
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic withdrawalDrug
stop antibiotics on viral or negative results
AntibioticsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| stop antibiotic | Experimental | Not described Receives: Drug: antibiotic withdrawal |
| standard of care | Active comparator | Not described Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days without antibiotics
Measured: day 30
Secondary outcomes (4)
number of side effects of antibiotics
Measured: day 30
Mortality at M1
Measured: day 30
martality at day 180
Measured: day 180
Length of hospitalization in acute care
Length of hospitalization in acute care (days)
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start14 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, Centre Hospitalier de Beauvais, University Hospital, Caen, Hôpital Les Bateliers, CHU de Lille, Centre Hospitalier Roubaix, CH SOISSONS, Tourcoing Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030673
- Sponsor's protocol ID
- PI2023_843_0153
- Acronym
- ABUSIV
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection
- ClinicalTrials.gov ID
- NCT07030673
- Acronym / sponsor ID
- ABUSIV / PI2023_843_0153
- Conditions
- Elderly, Antibiotics Overuse, Viral Infections, PCR Multiplex
- Keywords
- viral infections, elderly, antibiotics overuse, PCR multiplex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, Centre Hospitalier de Beauvais, University Hospital, Caen, Hôpital Les Bateliers, CHU de Lille, Centre Hospitalier Roubaix, CH SOISSONS, Tourcoing Hospital
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stop antibiotic | Experimental | Drug: antibiotic withdrawal |
| standard of care | Active comparator | Drug: Antibiotics |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Patients ≥ 65 years affiliated to a social security scheme
- Hospitalized for a lower respiratory infection defined as:
- Microbiological diagnostic sample taken within 48 hours
- Informed consent of the patient or their representative
Key exclusion criteria (8 listed)
- Hospitalization planned for < 48 hours or transfer planned to another center within 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic withdrawalstop antibiotics on viral or negative results | Drug | stop antibiotic |
| Antibioticsstandard 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 | Drug | standard of care |
Primary outcome
Number of days without antibiotics
Time frame: day 30
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic withdrawal and Antibiotics in people with Elderly and Antibiotics Overuse, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe LANOIX, Pr (33+32668813, lanoix.jean-philippe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days without antibiotics (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.