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

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

Study Overview

• Status: Unknown
• Conditions: Pleural Infection
• Intervention / Treatment: Drug: Antibiotics

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous therapy; Intravenous antibiotics administered for pleural space infection	Drug: Antibiotics; Oral versus intravenous therapy
Active Comparator: Oral therapy; Oral antibiotics administered for pleural space infection	Drug: Antibiotics; Oral versus intravenous therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment feasibility	Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure	3 months
Completion feasibility	Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
Mortality	All-cause mortality at 3 months	3 months
Antibiotic duration	Duration of antibiotics with start date as the date of randomization	3 months
Hospitalization duration	Duration of hospitalization	3 months
Stopping antibiotics	Early termination of antibiotics due to patient intolerance, patient preference or any other reason.	3 months
IV line complications	Infection, thrombosis or new line placement for IV catheter-related issues.	3 months
C. difficile	Clostridium difficile associated diarrhea as per the accepted PIDAC definition	3 months

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: Vaibhav Mokashi

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: PSI Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No