Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07240077

Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia

A double-blind randomized controlled trial comparing beta-lactam plus levofloxacin versus beta-lactam monotherapy for the treatment of Streptococcal bacteremia

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Streptococcal Infections Streptococcus Infection Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Siriraj Hospital, Bangkok, Thailand

Loading trial locations.

About this study

This randomized, double-blind clinical trial enrolls hospitalized or outpatient adults (≥18 years) with blood cultures positive for Streptococcus spp. who are receiving intravenous beta-lactam monotherapy. Eligible participants continue beta-lactam therapy and are randomized (block size of 4, stratified by site) to receive either intravenous levofloxacin 750 mg once daily or a normal saline placebo for 3-7 days, with dosing adjusted for renal function. The primary outcome is a composite endpoint of unfavorable events, and the secondary outcome is the duration of bacteremia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age>18 years
  • Blood culture positive for Streptococcus (<72 hours before enrollment)
  • at least 1 bottle of S. pyogenes, S. agalactiae, S. pneumoniae, S. suis
  • at least 2 bottle of other Streptococci
  • Receiving or having plan of receiving beta-lactam therapy

Exclusion criteria

  • Known allergy to beta-lactam or fluroquinolone antibiotics
  • Pregnancy or lactating mother
  • EKG with QT prolongation
  • Diagnosis of infective endocarditis

Treatment and study plan

Beta-lactam monotherapy

Drug

Normal saline placebo

Beta-lactam plus levofloxacin combination therapy

Drug

IV Levofloxacin

Primary outcomes

  1. Composite endpointof unfavorable outcome

    Time frame: 28 days after the onset of infection

    a composite endpoint comprising persistent bacteremia lasting more than 5 days, 28-day all-cause mortality, and the development of new metastatic foci within 28 days from infection onset

Secondary outcomes

  1. Duration of bacteremia

    Time frame: 28 days after the onset of infection

    Duration of bacteremia

Study contacts

Contact information is provided by the study sponsor or research team.

Pinyo Rattanaumpawan

CONTACT

[email protected]

66897778176

Wanwisa Chanapai

CONTACT

[email protected]

6624197000

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Beta-lactam Monotherapy Versus Beta-lactam Plus Levofloxacin for the Treatment of Streptococcal Bacteremia: A Multicenter, Randomized, Double-Blind, Pragmatic Trial

Acronym: BLESS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.