Short Versus Long Duration of Therapy for Streptococcus P... | NCT06096025

Studies
Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections

NCT06096025

Sponsor

Methodist Health System

Status

Active, not recruiting

Last Update Posted

Jul 4, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Streptococcus Pneumoniae

Interventions

pneumoniae bacteremia therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2023Actual

Primary Completion Date

Jun 23, 2026Estimated

Completion Date

Jun 23, 2026Estimated

First Submitted Date

Oct 17, 2023

First Submission Date that Met QC Criteria

Oct 17, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2025

Last Update Posted Date

Jul 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pneumoniae bacteremia therapy	Drug	To evaluate the effectiveness of short 10 days versus long (≥10 days) duration of therapy associated with S. pneumoniae bacteremia.		Total antibiotic treatment duration

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
ICU Length of stay(LOS)	length of ICU stay	30 days
Hospital LOS	length of hospital stay	30 days

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Crotty, PharmD	Methodist Midlothian Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center		Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code

Time Frame

2 years

Access Criteria

Clinical Trials portal

URL

Not provided