Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial
Primary Purpose
Pleural Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intravenous therapy
Oral therapy
Arm Description
Intravenous antibiotics administered for pleural space infection
Oral antibiotics administered for pleural space infection
Outcomes
Primary Outcome Measures
Enrollment feasibility
Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure
Completion feasibility
Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call
Secondary Outcome Measures
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.
Mortality
All-cause mortality at 3 months
Antibiotic duration
Duration of antibiotics with start date as the date of randomization
Hospitalization duration
Duration of hospitalization
Stopping antibiotics
Early termination of antibiotics due to patient intolerance, patient preference or any other reason.
IV line complications
Infection, thrombosis or new line placement for IV catheter-related issues.
C. difficile
Clostridium difficile associated diarrhea as per the accepted PIDAC definition
Full Information
NCT ID
NCT04301869
First Posted
March 6, 2020
Last Updated
March 6, 2020
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Vaibhav Mokashi
1. Study Identification
Unique Protocol Identification Number
NCT04301869
Brief Title
Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial
Official Title
Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Vaibhav Mokashi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous therapy
Arm Type
Active Comparator
Arm Description
Intravenous antibiotics administered for pleural space infection
Arm Title
Oral therapy
Arm Type
Active Comparator
Arm Description
Oral antibiotics administered for pleural space infection
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Description
Oral versus intravenous therapy
Primary Outcome Measure Information:
Title
Enrollment feasibility
Description
Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure
Time Frame
3 months
Title
Completion feasibility
Description
Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Treatment failure
Description
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
Title
Mortality
Description
All-cause mortality at 3 months
Time Frame
3 months
Title
Antibiotic duration
Description
Duration of antibiotics with start date as the date of randomization
Time Frame
3 months
Title
Hospitalization duration
Description
Duration of hospitalization
Time Frame
3 months
Title
Stopping antibiotics
Description
Early termination of antibiotics due to patient intolerance, patient preference or any other reason.
Time Frame
3 months
Title
IV line complications
Description
Infection, thrombosis or new line placement for IV catheter-related issues.
Time Frame
3 months
Title
C. difficile
Description
Clostridium difficile associated diarrhea as per the accepted PIDAC definition
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial
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