Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06715306

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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