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

St. Joseph's Healthcare Hamilton

Status: Unknown

Conditions: Pleural Infection

Treatments: Drug: Antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04301869

PSI Trial

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must meet our study definition of pleural space infection
• Age > or = 18 years old
• Life expectancy > 1 year
• Received intravenous or oral antibiotics for = or < 7 d from surgical intervention or received a total of = or < 7 d of antibiotics if no intervention performed

Exclusion criteria

• S. aureus bacteremia or endocarditis in the last 1 month
• Another concomitant infection requiring prolonged IV antibiotics
• Esophageal rupture or malignant pleural effusion
• Septic shock or systemic features requiring IV antibiotics
• Mycobacterial, fungal or parasitic pleural space infection
• No oral antibiotic options available
• Unlikely to comply with therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intravenous therapy

Active Comparator group

Description:

Intravenous antibiotics administered for pleural space infection

Treatment:

Drug: Antibiotics

Oral therapy

Active Comparator group

Description:

Oral antibiotics administered for pleural space infection

Treatment:

Drug: Antibiotics