Intravenous Versus Oral Treatment of the Main Acute Infections

NCT06715306 | Recruiting

• 1 other identifier: SHS-ED-1-2024
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 7

Brief 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. 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 Based on an extrapolated estimate from an unpublished local survey, approximately 50,000 patients in Denmark are admitted each year for infections and treated with IV antibiotics.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.

Conditions

Respiratory Tract Infections; Urinary Tract Infections; Cellulitis

Keywords

Oral antibiotic therapy; intravenous antibiotic therapy; intravenous-to-oral-switch

Outcome Measures

Primary Outcomes (2)

• Days alive outside hospital (Efficacy)

  The number of days the patients are alive outside hospital within 30 days after randomization

  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

  From date of randomization to 30 days

Secondary Outcomes (11)

• Length of hospital stay

  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

  From date of randomization until date of death in hospital from any cause, assessed up to 6 months

• 30-days mortality

  up to 30 days from baseline (randomization date)

• 90-days mortality

  Up to 90 days from baseline (randomization date)

• One-year mortality

  Up to one-year from baseline (randomization date)

Study Arms (2)

Standard Care

NO INTERVENTION

Standard intravenous treatment in accordance with local or national procedures

Oral treatment

ACTIVE COMPARATOR

Oral treatment

Other: Oral treatment

Interventions

Oral treatment OTHER

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).

Oral treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected respiratory tract infection, urinary tract infection, or cellulitis by the attending physician
• Planned or initiated intravenous antibiotic treatment

You may not qualify if:

• 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;
• unable to give informed consent;
• severe immunodeficiency;
• urgent vital treatment needed.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (7)

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

RECRUITING

Bispebjerg and Frederiksberg Hospital

Copenhagen, 2400, Denmark

ACTIVE NOT RECRUITING

Nordsjællands Hospital

Copenhagen, Denmark

RECRUITING

Esbjerg and Grindsted Sygehus

Esbjerg, 6700, Denmark

RECRUITING

Herlev and Gentofte Hospital

Herlev, 2730, Denmark

ACTIVE NOT RECRUITING

Amager and Hvidovre Hospital

Hvidovre, 2650, Denmark

ACTIVE NOT RECRUITING

Sygehus Lillebælt

Kolding, 6000, Denmark

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Urinary Tract Infections; Cellulitis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mariana Bichuette Cartuliares

CONTACT

+45 79971113; mbc@rsyd.dk

Helene Skjøt-Arkil

CONTACT

+45 79971113; hsa@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: December 4, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 6, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7)