Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections

Streptococcus Pneumoniae Clinical Trial

Official title:

Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096025
• Other study ID #: 026.PHA.2023.A
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: June 23, 2024

Study information

• Verified date: November 2023
• Source: Methodist Health System
• Contact: Bethany Brauer, MPH
• Phone: 214-947-4681
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Streptococcus pneumoniae is a gram-positive (GP) bacteria responsible for common infections such as community-acquired pneumonia (CAP), as well as complicated infections such as bacteremia, infective endocarditis and meningitis. S. pneumoniae bacteremia ranks among the top 10 most common pathogens associated with bloodstream infections and correlates with high morbidity and mortality worldwide.

Description:

The Infectious Diseases Society of America (IDSA) guidelines for CAP management advocate for short courses of antibiotics for CAP treatment. However, it does not address duration of therapy for common CAP pathogens such as S. pneumoniae when associated with blood stream infections (BSI). 3

Currently, GP bacteremia duration of therapy typically ranges from 7 to 14 days based on IDSA guideline recommendations for Staphylococcus aureus bacteremia with no further definitive consensus.4 Additionally, lack of data and randomized clinical trials on the efficacy and safety of short compared to long treatment duration have led to variability in practice. Most randomized clinical trials as well as retrospective studies on treatment duration, have been conducted mainly in gram-negative BSI

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 23, 2024
• Est. primary completion date: June 23, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• • =18 years of age

• S. pneumoniae isolated from =1 blood cultures

• Active IV antibiotic therapy within 48 hours of the first positive blood culture(7,8)

• Clinical stability by day 10 of therapy

Exclusion Criteria:

• • Treatment duration <5 days or >16 days

• Death before completion of therapy (<10 days vs. = 10 days )

• Polymicrobial BSI

• Invasive infection caused by S. pneumoniae (endocarditis, meningitis, and lung abscess)

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumococcal
• Streptococcus Pneumoniae

Intervention

Drug:
• pneumoniae bacteremia therapy
To evaluate the effectiveness of short 10 days versus long (=10 days) duration of therapy associated with S. pneumoniae bacteremia.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection related-hospitalization	hospital readmission with streptococcal pneumonia, bacteremia, endocarditis, meningitis, and lung abscess within 30 days of antibiotic completion	30 days
Primary	Recurrence	Reinfection with streptococcal pneumonia, within 30 days of antibiotic completion	30 days
Primary	All-cause mortality	Death within 30 days of antibiotic completion	30 days
Secondary	ICU Length of stay(LOS)	length of ICU stay	30 days
Secondary	Hospital LOS	length of hospital stay	30 days
Secondary	Occurrence of C. difficile infection	Number of times of C.difficile infections	30 days
Secondary	Total antibiotic treatment duration	Number of times of antibiotic treatment duration	30 days
Secondary	Central venous catheter placement	placement of venous catheter	30 days