NCT06096025

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jun 2023Jun 2026

Study Start

First participant enrolled

June 23, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2026

Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

October 17, 2023

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • ICU Length of stay(LOS)

    30 days

  • Hospital LOS

    30 days

  • Occurrence of C. difficile infection

    30 days

  • Total antibiotic treatment duration

    30 days

  • Central venous catheter placement

    30 days

Interventions

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

Also known as: Total antibiotic treatment duration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • ≥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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

  • Matthew Crotty, PharmD

    Methodist Midlothian Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

June 23, 2023

Primary Completion (Estimated)

June 23, 2026

Study Completion (Estimated)

June 23, 2026

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
2 years
Access Criteria
Clinical Trials portal

Locations