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

NCT ID: NCT04301869

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2021-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous therapy

Intravenous antibiotics administered for pleural space infection

Group Type: ACTIVE_COMPARATOR

Antibiotics

Intervention Type: DRUG

Oral versus intravenous therapy

Oral therapy

Oral antibiotics administered for pleural space infection

Group Type: ACTIVE_COMPARATOR

Antibiotics

Intervention Type: DRUG

Oral versus intravenous therapy

Interventions

Antibiotics

Oral versus intravenous therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vaibhav Mokashi

UNKNOWN

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Phillipe El-Helou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PSI Trial

Identifier Type: -

Identifier Source: org_study_id