NCT05045612 Antibiotic Therapy in Viral Airway Infections
| NCT ID | NCT05045612 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Akershus |
| Condition | Infectious Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2022-01-13 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 380 participants in total. It began in 2022-01-13 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In the current proposal, the investigators aim to assess the efficacy and safety of early discontinuation of antibiotic therapy in adult patients infected with respiratory viruses. A general recommendation to treat all instances of community acquired pneumonia (CAP) patients with antibiotics leads to significant antibiotic overtreatment. In 2008, the US Food and Drug Administration approved the first multiplex polymerase chain reaction assay for the detection of multiple respiratory virus nucleic acids simultaneously. The wide availability of such nucleic acid amplification tests (NAAT) for rapid viral detection together with chest radiographs has the potential to define patients who can be managed without antibiotics. Akershus University Hospital is one of the largest hospitals in Norway, with a catchment area of more than 550,000 people. In 2012 to 2013, the majority of patients admitted to Akershus University Hospital with suspected CAP and a positive viral NAAT were treated with antibiotics, a prescription pattern representing antibiotic overtreatment. The investigators accordingly hypothesize that discontinuation of antibiotic therapy in patients with moderately severe disease and airway sample positive for respiratory viruses is safe and non-inferior to continuation of antibiotic therapy.
Eligibility Criteria
Inclusion Criteria: * Hospitalized * Adults 18 year or older * Moderately severe disease (CRB65 ≤ 2 at time of inclusion) * Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV) * On antibiotic therapy as instituted by the receiving physician from the emergency department * Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations. Exclusion Criteria: * Requiring ICU admission at screening * Requiring high-flow oxygen therapy or non-invasive ventilation at screening * Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology) * Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling ≥ 20 mg prednisolone daily for ≥ 4 weeks, chronic immunosuppression due to solid organ transplant) * SARS-CoV-2 positive * Bacteremia * Urine antigen test positive for legionella * Any other infection necessitating antibiotic treatment * Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital * Time from initiation of antibiotic therapy to screening \>48 hours
Contact & Investigator
Magnus N Lyngbakken, MD PhD
PRINCIPAL INVESTIGATOR
University Hospital, Akershus
Frequently Asked Questions
Who can join the NCT05045612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infectious Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05045612 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05045612 currently recruiting?
Yes, NCT05045612 is actively recruiting participants. Contact the research team at magnus.lyngbakken@medisin.uio.no for enrollment information.
Where is the NCT05045612 trial being conducted?
This trial is being conducted at Bergen, Norway, Drammen, Norway, Gjettum, Norway, Grålum, Norway and 8 additional locations.
Who is sponsoring the NCT05045612 clinical trial?
NCT05045612 is sponsored by University Hospital, Akershus. The principal investigator is Magnus N Lyngbakken, MD PhD at University Hospital, Akershus. The trial plans to enroll 380 participants.