NCT04301869

Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We aim to conduct a pilot trial assessing oral versus intravenous therapy for pleural space infections.

Detailed description

Pleural space infections are a frequent clinical problem resulting in significant morbidity and mortality as well as healthcare cost. Despite the increasing burden of disease, there are no clinical trials evaluating antibiotic therapy in pleural space infections. Hence, British and American guidelines are only able to provide weak and vague recommendations regarding duration, type or route (intravenous or oral) of antibiotic therapy. Our goal is to determine whether oral (PO) therapy is non-inferior to intravenous (IV) therapy thereby decreasing risks of IV catheter related infections, vein thrombosis and health care costs. Similar studies have been successfully conducted in the setting of bone/joint infections and endocarditis and showed non-inferiority of oral antibiotics. However, in order to help ensure that the randomized trial is of good quality, it is important to assess the feasibility of such a trial by first conducting a pilot study. The goal of this pilot trial is to assess the feasibility of the proposed study design.

Conditions

• Pleural Infection

Interventions

Type	Name	Description
DRUG	Antibiotics	Oral versus intravenous therapy

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-03-10
• Last updated: 2020-03-10