An interventional study of Oral treatment in Respiratory Tract Infections, Urinary Tract Infections and Cellulitis, sponsored by University of Southern Denmark. Recruiting at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment
Patients admitted to the hospital with acute infections are often treated with intravenous (IV) antibiotics. Around 70% of these infections fall into three categories: respiratory tract infections, urinary tract infections, and cellulitis. A Danish study found that 76% of patients admitted with suspected community-acquired pneumonia and treated with antibiotics received them intravenously. Based on an extrapolated estimate from an unpublished local survey, approximately 50,000 patients in Denmark are admitted each year for infections and treated with IV antibiotics. The average hospital stay for these patients is 5.9 days, resulting in a total of 295,000 hospital days annually, accounting for about 7% of total hospital admissions in Denmark. This represents an annual cost of 2.3 billion DKK. While some patients need hospitalization due to their overall health or other serious conditions, others remain hospitalized primarily to receive IV antibiotics.
Expanding the use of oral antibiotics in emergency departments should be pursued only if it can demonstrate comparable efficacy and safety to IV administration. Therefore this study will investigate the efficiency of primarily oral antibiotics in acutely admitted patients with proven or suspected infections. Additionally, the investigators will evaluate the safety of oral regimen for these patients.
Patients admitted to the hospital with infections are often treated with intravenous antibiotics. The rationale for using intravenous antibiotics includes eliminating the risk of reduced absorption, achieving higher serum concentrations, and the fact that many broad-spectrum antibiotics (such as cephalosporins and carbapenems) are not available in oral form. However, intravenous antibiotics also have drawbacks, such as the risk of catheter-related infections, challenges in home-based treatment, and difficulty switching to oral antibiotics unless microbiological results are definitively positive. Prolonged hospital stays associated with intravenous antibiotic treatment lead to economic burdens, increased risk of hospital-acquired infections, and significant functional decline, especially in older patients.
In recent decades, many studies have explored the possibility of fully or partially replacing intravenous antibiotics with oral antibiotics for certain infections.
In this study, the investigators will examine the safety and efficacy of primarily oral antibiotic regimens in patients with confirmed or suspected infections admitted to the emergency department. The study is an open-label, prospective, randomized controlled trial. Participants will be randomly assigned to receive either standard intravenous antibiotic treatment according to Danish guidelines or oral antibiotic treatment based on tailored recommendations developed by microbiologists and infectious disease specialists at participating sites, in accordance with local guidelines.
The study has two primary outcomes: 1) Efficacy-measured as the number of days alive outside the hospital within 30 days after randomization, and 2) Safety-measured by mortality or the need for vasopressors within 30 days after randomization. A total of 4,000 patients will be needed to address both primary outcomes.
Aim: The trial aims to investigate the safety and efficacy of oral antibiotic administration compared to intravenous antibiotic administration in patients referred to the emergency department with suspected or diagnosed bacterial pneumonia, urinary tract infection and cellulitis.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 200 across 540 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard intravenous treatment in accordance with local or national procedures
Oral treatment
Other: Oral treatment
Patients randomized to oral treatment will commence the oral treatment immediately. The oral treatment is based on specially developed treatment suggestions developed by microbiologists and specialists in infectious diseases from the participating regions, and in respect with local treatment guidelines (detailed described in the protocol).
Days alive outside hospital (Efficacy)
The number of days the patients are alive outside hospital within 30 days after randomization
Time frame: From randomization date to 30 days
Number of patients requiring treatment with vasopressors
Number of patients that die or number of patients that require treatment with vasopressors within 30 days after randomization
Time frame: From date of randomization to 30 days
Length of hospital stay
Duration of hospital length of stay in days
Time frame: From date of randomization until date of documented hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months
Inhospital mortality
The number of death measured inhospital before discharge
Time frame: From date of randomization until date of death in hospital from any cause, assessed up to 6 months
30-days mortality
The number of death within 30 days
Time frame: up to 30 days from baseline (randomization date)
90-days mortality
The number of death within 90 days
Time frame: Up to 90 days from baseline (randomization date)
One-year mortality
The number of death within one-year
Time frame: Up to one-year from baseline (randomization date)
Five-year mortality
The number of death within five-years
Time frame: Up to five-years from baseline (randomization date)
Discharge within 24 hours
The number of patients discharged within 24 hours
Time frame: Up to 24 hours after rom baseline (randomization date)
Readmission
The number of patients readmitted to hospital
Time frame: 30 days after discharge date
Intensive care admission
Number of patients admitted to intensive care during current hospital stay
Time frame: From date of randomization until date of admission to intensive care during hospitalization due to any cause, assessed up to 6 months
Days on antibiotic treatment within 30 days
Number of days the patient have been treated with antibiotics
Time frame: Within 30 days from randomization date
Bacteremia
Number of patients diagnosed with bacteremia
Time frame: Day 7 to day 30 from randomization date
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Plan to share: No
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Started Jan 2025 (actual). Primary completion is estimated for Jan 2027, 23 months after the start.
Of 116 non-industry interventional studies with no phase under Respiratory Tract Infections, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 23 months is above that.
Counting every sponsor, half of 143 studies reached it within 11 months; a quarter within 6 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
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Respiratory Tract Infections →
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