Respiratory Tract InfectionsNCT06715306
Intravenous Versus Oral Treatment of the Main Acute Infections
A study testing Oral treatment in people with Respiratory Tract Infections and Urinary Tract Infections, run by University of Southern Denmark at 7 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections, Urinary Tract Infections, Cellulitis
- What is being tested?
- Oral treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 7 sitesDenmark
- Study dates
- 15 Jan 2025to 6 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected respiratory tract infection, urinary tract infection, or cellulitis by the attending physician
- Planned or initiated intravenous antibiotic treatment
Who cannot join
- 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;
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- unable to give informed consent;
- severe immunodeficiency;
- urgent vital treatment needed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Denmark7 sites, 4 recruiting
- Recruiting
Sygehus Sønderjylland
Aabenraa, Southern Denmark, 6200
- Active, not recruiting
Bispebjerg and Frederiksberg Hospital
Copenhagen, 2400
- Recruiting
Nordsjællands Hospital
Copenhagen
Jon Gitz Holler
- Recruiting
Esbjerg and Grindsted Sygehus
Esbjerg, 6700
Peter Biesenbach
- Active, not recruiting
Herlev and Gentofte Hospital
Herlev, 2730
- Active, not recruiting
Amager and Hvidovre Hospital
Hvidovre, 2650
- Recruiting
Sygehus Lillebælt
Kolding, 6000
Lone Wulff Madsen
About this study
Official title: Intravenous Versus Oral Treatment of the Main Acute Infections in Emergency Departments
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.
Read the detailed description
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.
- Being tested
- Oral treatment
- Keywords
- Oral antibiotic therapy, intravenous antibiotic therapy, intravenous-to-oral-switch
- Medical subject headings
- Respiratory Tract Infections, Urinary Tract Infections, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral treatmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard intravenous treatment in accordance with local or national procedures |
| Oral treatment | Active comparator | Oral treatment Receives: Other: Oral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive outside hospital (Efficacy)
The number of days the patients are alive outside hospital within 30 days after randomization
Measured: 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
Measured: From date of randomization to 30 days
Secondary outcomes (11)
Length of hospital stay
Duration of hospital length of stay in days
Measured: 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
Measured: 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
Measured: up to 30 days from baseline (randomization date)
90-days mortality
The number of death within 90 days
Measured: Up to 90 days from baseline (randomization date)
One-year mortality
The number of death within one-year
Measured: Up to one-year from baseline (randomization date)
Five-year mortality
The number of death within five-years
Measured: Up to five-years from baseline (randomization date)
Discharge within 24 hours
The number of patients discharged within 24 hours
Measured: Up to 24 hours after rom baseline (randomization date)
Readmission
The number of patients readmitted to hospital
Measured: 30 days after discharge date
Intensive care admission
Number of patients admitted to intensive care during current hospital stay
Measured: 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
Measured: Within 30 days from randomization date
Bacteremia
Number of patients diagnosed with bacteremia
Measured: Day 7 to day 30 from randomization date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start15 Jan 2025
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715306
- Sponsor's protocol ID
- SHS-ED-1-2024
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Oral Treatment of the Main Acute Infections in Emergency Departments
- ClinicalTrials.gov ID
- NCT06715306
- Acronym / sponsor ID
- SHS-ED-1-2024
- Keywords
- Oral antibiotic therapy, intravenous antibiotic therapy, intravenous-to-oral-switch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jan 2028 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard intravenous treatment in accordance with local or national procedures |
| Oral treatment | Active comparator | Other: Oral treatmentOral treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected respiratory tract infection, urinary tract infection, or cellulitis by the attending physician
- Planned or initiated intravenous antibiotic treatment
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral treatmentPatients 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). | Other | Oral treatment |
Primary outcome
Days alive outside hospital (Efficacy)
Time frame: From randomization date to 30 days
The number of days the patients are alive outside hospital within 30 days after randomization
Number of patients requiring treatment with vasopressors
Time frame: From date of randomization to 30 days
Number of patients that die or number of patients that require treatment with vasopressors within 30 days after randomization
11 secondary outcomes
Length of hospital stay
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
Time frame: From date of randomization until date of death in hospital from any cause, assessed up to 6 months
30-days mortality
Time frame: up to 30 days from baseline (randomization date)
90-days mortality
Time frame: Up to 90 days from baseline (randomization date)
One-year mortality
Time frame: Up to one-year from baseline (randomization date)
Five-year mortality
Time frame: Up to five-years from baseline (randomization date)
Discharge within 24 hours
Time frame: Up to 24 hours after rom baseline (randomization date)
Readmission
Time frame: 30 days after discharge date
Intensive care admission
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
Time frame: Within 30 days from randomization date
Bacteremia
Time frame: Day 7 to day 30 from randomization date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral treatment in people with Respiratory Tract Infections and Urinary Tract Infections, run by University of Southern Denmark at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Bichuette Cartuliares (+45 79971113, mbc@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive outside hospital (Efficacy) (time frame: From randomization date to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.