Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections

Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Streptococcus Pneumoniae
• Intervention / Treatment: 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 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Matthew Crotty, PharmD, Methodist Midlothian Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Pneumonia, Bacterial; Pneumonia; Pneumonia, Pneumococcal; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 026.PHA.2023.A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at scientific meetings and/or publication in Open Access Journals.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Clinical Trials portal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No