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Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT06096025
Collaborator
(none)
200
Enrollment
1
Location
12
Anticipated Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: pneumoniae bacteremia therapy

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 Staphylcoccus 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream
Actual Study Start Date :
Jun 23, 2023
Anticipated Primary Completion Date :
Jun 23, 2024
Anticipated Study Completion Date :
Jun 23, 2024

Outcome Measures

Primary Outcome Measures

  1. clinical efficacy of short-term antibiotic [7 days]

    To assess the clinical efficacy of short-term antibiotic duration compared to longer antibiotic duration for treatment of S. pneumoniae bacteremia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

  • • ≥18 years of age

    1. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Matthew Crotty, PharmD, Methodist Midlothian Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT06096025
Other Study ID Numbers:
  • 026.PHA.2023.A
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumococcal
Anti-Bacterial Agents

Study Results

No Results Posted as of Oct 23, 2023