Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07240077

Acronym

BLESS

Enrollment

165

Registered

2025-11-20

Start date

2026-01-08

Completion date

2028-12-31

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Streptococcus Infection

Keywords

bacteremia, streptococcus, levofloxacin

Brief summary

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

Detailed description

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

Interventions

DRUGBeta-lactam monotherapy

Normal saline placebo

DRUGBeta-lactam plus levofloxacin combination therapy

IV Levofloxacin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults age\>18 years 2. 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 3. Receiving or having plan of receiving beta-lactam therapy

Exclusion criteria

1. Known allergy to beta-lactam or fluroquinolone antibiotics 2. Pregnancy or lactating mother 3. EKG with QT prolongation 4. Diagnosis of infective endocarditis

Design outcomes

Primary

Measure	Time frame	Description
Composite endpointof unfavorable outcome	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

Measure	Time frame	Description
Duration of bacteremia	28 days after the onset of infection	Duration of bacteremia

Countries

Thailand

Contacts

CONTACTPinyo Rattanaumpawan

pinyo.rat@mahidol.ac.th66897778176

CONTACTWanwisa Chanapai

wanwisa.cha@mahidol.ac.th6624197000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026