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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06096025
Other study ID # 026.PHA.2023.A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 23, 2023
Est. completion date June 23, 2024

Study information

Verified date November 2023
Source Methodist Health System
Contact Bethany Brauer, MPH
Phone 214-947-4681
Email MHSIRB@mhd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 23, 2024
Est. primary completion date June 23, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infection related-hospitalization hospital readmission with streptococcal pneumonia, bacteremia, endocarditis, meningitis, and lung abscess within 30 days of antibiotic completion 30 days
Primary Recurrence Reinfection with streptococcal pneumonia, within 30 days of antibiotic completion 30 days
Primary All-cause mortality Death within 30 days of antibiotic completion 30 days
Secondary ICU Length of stay(LOS) length of ICU stay 30 days
Secondary Hospital LOS length of hospital stay 30 days
Secondary Occurrence of C. difficile infection Number of times of C.difficile infections 30 days
Secondary Total antibiotic treatment duration Number of times of antibiotic treatment duration 30 days
Secondary Central venous catheter placement placement of venous catheter 30 days
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