Stopping antibiotics early in older adults hospitalized with a viral lung infection
Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection
This trial will test whether stopping antibiotics early is safe and helpful for people 65 and older who are hospitalized with a confirmed viral lower respiratory infection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT07030673 on ClinicalTrials.gov |
What this trial studies
Older adults hospitalized with signs of lower respiratory infection will have microbiological sampling within 48 hours and multiplex PCR testing to identify viral pathogens. When a viral infection is identified and there is no evidence of bacterial co-infection, the protocol calls for early discontinuation of antibiotics; patients will then be followed for clinical outcomes, complications, and need to restart antibiotics. The intervention is being implemented at university hospitals in France and compared with usual antibiotic management pathways. The goal is to measure safety, clinical recovery, and antibiotic exposure in this higher-risk, comorbid population.
Who should consider this trial
Good fit: Ideal candidates are people aged 65 or older who are hospitalized for a lower respiratory infection, have a microbiological diagnostic sample taken within 48 hours, and can provide informed consent (or have a representative who can).
Not a fit: Patients with septic shock, febrile aplasia, proven inhalation, purulent pleurisy or lung abscess, other bacterial infections requiring antibiotics, moribund patients, or those without timely microbiological sampling are unlikely to benefit from early antibiotic discontinuation.
Why it matters
Potential benefit: If successful, the approach could safely reduce unnecessary antibiotic exposure, antibiotic-related side effects, and contribution to antimicrobial resistance in elderly inpatients.
How similar studies have performed: Previous antibiotic stewardship efforts using rapid viral testing have reduced antibiotic use in some adult populations, but robust evidence specifically in frail elderly inpatients is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amiens
- CHRU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Jean-Philippe LANOIX, Pr
- Email: lanoix.jean-philippe@chu-amiens.fr
- Phone: 33+32668813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.