Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia
BLESS
Beta-lactam Monotherapy Versus Beta-lactam Plus Levofloxacin for the Treatment of Streptococcal Bacteremia: A Multicenter, Randomized, Double-Blind, Pragmatic Trial
1 other identifier
interventional
165
1 country
4
Brief Summary
A double-blind randomized controlled trial comparing beta-lactam plus levofloxacin versus beta-lactam monotherapy for the treatment of Streptococcal bacteremia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2026
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 20, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
November 20, 2025
November 1, 2025
2 years
November 14, 2025
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite endpointof unfavorable outcome
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
28 days after the onset of infection
Secondary Outcomes (1)
Duration of bacteremia
28 days after the onset of infection
Study Arms (2)
Beta-lactam monotherapy
PLACEBO COMPARATORNormal saline 150 cc IV drip in 90 minutes once daily for 3-7 days (in a blinding package)
Levofloxacin combination therapy
EXPERIMENTALLevofloxacin 750 mg IV drip in 90 minutes once daily for 3-7 days (in a blinding package)
Interventions
IV Levofloxacin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known allergy to beta-lactam or fluroquinolone antibiotics
- Pregnancy or lactating mother
- EKG with QT prolongation
- Diagnosis of infective endocarditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Faculty of Medicine Siriraj Hospital
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Maharaj Nakhon Ratchasima
Nakhon Ratchasima, Thailand
Ratchburi Hospital
Ratchaburi, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 20, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share