Comparing intravenous and oral antibiotics for acute infections
Intravenous Versus Oral Treatment of the Main Acute Infections in Emergency Departments
This study tests if oral antibiotics can work just as well as intravenous ones for people in the hospital with acute infections to see if they can shorten hospital stays and lower risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 7 sites (Aabenraa, Southern Denmark and 6 other locations) |
| Trial ID | NCT06715306 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of oral antibiotic regimens compared to standard intravenous antibiotic treatment in patients admitted to the hospital with acute infections such as respiratory tract infections, urinary tract infections, and cellulitis. Participants will be randomly assigned to receive either intravenous antibiotics or tailored oral antibiotics based on microbiological recommendations. The goal is to determine if oral antibiotics can effectively replace intravenous treatment, potentially reducing hospital stays and associated risks. The study is designed as an open-label, prospective, randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are patients admitted with suspected respiratory tract infections, urinary tract infections, or cellulitis who are planned to receive intravenous antibiotics.
Not a fit: Patients who have received more than two doses of intravenous antibiotics or have severe health conditions requiring immediate intravenous treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter hospital stays and reduced healthcare costs for patients with acute infections.
How similar studies have performed: Previous studies have explored the use of oral antibiotics in similar contexts, showing promising results, but this specific approach is still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspected respiratory tract infection, urinary tract infection, or cellulitis by the attending physician * Planned or initiated intravenous antibiotic treatment Exclusion Criteria: * if received more than two doses of intravenous antibiotics; * systolic blood pressure \<90 mmHg; * nausea and/or vomiting in more than one short-term instance during the last 2 days; * suspected significantly reduced gastrointestinal absorption; * confirmed plasma-lactate \> 2; * pregnant or nursing; * unable to give informed consent; * severe immunodeficiency; * urgent vital treatment needed.
Where this trial is running
Aabenraa, Southern Denmark and 6 other locations
- Sygehus Sønderjylland — Aabenraa, Southern Denmark, Denmark (Recruiting)
- Bispebjerg and Frederiksberg Hospital — Copenhagen, Denmark (Active_not_recruiting)
- Nordsjællands Hospital — Copenhagen, Denmark (Recruiting)
- Esbjerg and Grindsted Sygehus — Esbjerg, Denmark (Recruiting)
- Herlev and Gentofte Hospital — Herlev, Denmark (Active_not_recruiting)
- Amager and Hvidovre Hospital — Hvidovre, Denmark (Active_not_recruiting)
- Sygehus Lillebælt — Kolding, Denmark (Recruiting)
Study contacts
- Study coordinator: Mariana Bichuette Cartuliares
- Email: mbc@rsyd.dk
- Phone: +45 79971113
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.