Intravenous Versus Oral Treatment of the Main Acute Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark
About this trial
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 Based on an extrapolated estimate from an unpublished local survey, approximately 50,000 patients in Denmark are admitted each year for infections and treated with IV antibiotics.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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected respiratory tract infection, urinary tract infection, or cellulitis by the attending physician
Planned or initiated intravenous antibiotic treatment
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Oral treatment
Other interventionPatients 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).
Treatment groups
4,000 Participants
are divided into 2 treatment groupsGroup A: Standard CareNo intervention 0 interventions
Group B: Oral treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 daysSecondary outcomes
1
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 months2
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 months3
30-days mortality
The number of death within 30 days
Time frame
up to 30 days from baseline (randomization date)4
90-days mortality
The number of death within 90 days
Time frame
Up to 90 days from baseline (randomization date)Sponsors and contacts
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Source ClinicalTrials.gov