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

St. Joseph's Healthcare Hamilton40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pleural Infection

Interventions

AntibioticsDRUG

Oral versus intravenous therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Enrollment feasibility

Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure

Time frame: 3 months

Completion feasibility

Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call

Time frame: 3 months

Secondary Outcomes

Treatment failure

Treatment failure at the 3-month clinical visit or phone conversation, defined as any of: (i) return to the emergency department for new fever, shortness of breath or progressive hypoxia OR (ii) radiological progression of empyema or development of a new abscess OR (iii) mortality related to pleural space infection. Treatment failure must be agreed upon by the majority of the adjudication committee.

Time frame: 3 months

Mortality

All-cause mortality at 3 months

Time frame: 3 months

Antibiotic duration

Duration of antibiotics with start date as the date of randomization

Time frame: 3 months

Hospitalization duration

Duration of hospitalization

Time frame: 3 months

Stopping antibiotics

Early termination of antibiotics due to patient intolerance, patient preference or any other reason.

Time frame: 3 months

IV line complications

Data from ClinicalTrials.gov

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