Actively Recruiting
Intravenous Versus Oral Treatment of the Main Acute Infections in Emergency Departments
Led by University of Southern Denmark · Updated on 2026-03-05
4000
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating oral versus intravenous antibiotic treatments for patients admitted to emergency departments with acute infections such as respiratory tract infections, urinary tract infections, and cellulitis. The study aims to determine if oral antibiotics can provide similar safety and effectiveness compared to standard intravenous treatment, potentially reducing hospital stays and associated costs. This open-label, prospective, randomized controlled trial is sponsored by the University of Southern Denmark and addresses a significant healthcare burden related to prolonged intravenous antibiotic use and hospital admissions. Participants will be randomly assigned to receive either standard intravenous antibiotics according to Danish guidelines or oral antibiotics based on recommendations developed by microbiologists and infectious disease specialists, tailored to local treatment guidelines. The oral treatment begins immediately upon randomization. The trial plans to enroll 4,000 patients to compare two primary outcomes: days alive outside the hospital within 30 days and safety measured by mortality or need for vasopressors within 30 days. During the study, participants will be monitored for various outcomes including length of hospital stay, mortality at multiple time points up to five years, readmission rates, intensive care admissions, days on antibiotic treatment, and occurrence of bacteremia. Data will be collected from the randomization date and patients will be followed for up to six months or longer depending on the outcome. This comprehensive assessment aims to evaluate both the efficacy and safety of oral antibiotic regimens in acute infections treated in emergency settings.
CONDITIONS
Brief Title
Intravenous Versus Oral Treatment of the Main Acute Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected respiratory tract infection, urinary tract infection, or cellulitis diagnosed by the attending physician
- Planned or initiated intravenous antibiotic treatment
- Age 18 years or older
You will not qualify if you...
- Received more than two doses of intravenous antibiotics
- Systolic blood pressure below 90 mmHg
- Experienced nausea and/or vomiting more than once in the last two days
- Suspected significantly reduced gastrointestinal absorption
- Confirmed plasma-lactate level greater than 2
- Pregnant or nursing
- Unable to give informed consent
- Severe immunodeficiency
- Urgent vital treatment needed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days from randomization
Participants receive either standard intravenous antibiotics or oral antibiotics based on tailored recommendations to treat their infection.
Visits as part of hospital care during treatment period
Duration - Up to 6 months from randomization
Participants are monitored for safety and treatment outcomes including hospital discharge, mortality, and readmission for up to 6 months after treatment starts.
Several follow-up visits depending on hospital stay and recovery
Trial Site Locations
Total: 7 locations
1
Sygehus Sønderjylland
Aabenraa, Southern Denmark, Denmark, 6200
Actively Recruiting
2
Bispebjerg and Frederiksberg Hospital
Copenhagen, Denmark, 2400
Active, Not Recruiting
3
Nordsjællands Hospital
Copenhagen, Denmark
Actively Recruiting
4
Esbjerg and Grindsted Sygehus
Esbjerg, Denmark, 6700
Actively Recruiting
5
Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Active, Not Recruiting
6
Amager and Hvidovre Hospital
Hvidovre, Denmark, 2650
Active, Not Recruiting
7
Sygehus Lillebælt
Kolding, Denmark, 6000
Actively Recruiting
Research Team
M
Mariana Bichuette Cartuliares
H
Helene Skjøt-Arkil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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