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

Pleural Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04301869
• Other study ID #: PSI Trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pleural Infection

Intervention

Drug:
• Antibiotics
Oral versus intravenous therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Vaibhav Mokashi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment feasibility	Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure	3 months
Primary	Completion feasibility	Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call	3 months
Secondary	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
Secondary	Mortality	All-cause mortality at 3 months	3 months
Secondary	Antibiotic duration	Duration of antibiotics with start date as the date of randomization	3 months
Secondary	Hospitalization duration	Duration of hospitalization	3 months
Secondary	Stopping antibiotics	Early termination of antibiotics due to patient intolerance, patient preference or any other reason.	3 months
Secondary	IV line complications	Infection, thrombosis or new line placement for IV catheter-related issues.	3 months
Secondary	C. difficile	Clostridium difficile associated diarrhea as per the accepted PIDAC definition	3 months