Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections

Recruiting

• Conditions: Streptococcus Pneumoniae

• Registration Number: NCT06096025
• Lead Sponsor: Methodist Health System

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2023-06-23
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06-23
• Study Completion: 2024-06-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence	30 days	Reinfection with streptococcal pneumonia, within 30 days of antibiotic completion
All-cause mortality	30 days	Death within 30 days of antibiotic completion
Infection related-hospitalization	30 days	hospital readmission with streptococcal pneumonia, bacteremia, endocarditis, meningitis, and lung abscess within 30 days of antibiotic completion

Secondary Outcome Measures

Name	Time	Method
Central venous catheter placement	30 days	placement of venous catheter
ICU Length of stay(LOS)	30 days	length of ICU stay
Hospital LOS	30 days	length of hospital stay
Occurrence of C. difficile infection	30 days	Number of times of C.difficile infections
Total antibiotic treatment duration	30 days	Number of times of antibiotic treatment duration

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States