Clinical trial NCT06096025: Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections
Official title: Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Streptococcus Pneumoniae
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥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

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

Eligibility criteria: 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)

Primary outcomes:
measure: Infection related-hospitalization
timeFrame: 30 days
measure: Recurrence
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: ICU Length of stay(LOS)
timeFrame: 30 days
measure: Hospital LOS
timeFrame: 30 days
measure: Occurrence of C. difficile infection
timeFrame: 30 days
measure: Total antibiotic treatment duration
timeFrame: 30 days
measure: Central venous catheter placement
timeFrame: 30 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Midlothian Medical Center
name: Matthew Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References: