Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia (BLESS)

Mahidol University

Status and phase: Not yet enrolling; Phase 4

Conditions: Streptococcus Infection; Bacteremia

Treatments: Drug: Beta-lactam monotherapy; Drug: Beta-lactam plus levofloxacin combination therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07240077

886/2568(IRB3)

Details and patient eligibility

About

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

Full 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

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 2 patient groups, including a placebo group

Beta-lactam monotherapy

Placebo Comparator group

Description:

Normal saline 150 cc IV drip in 90 minutes once daily for 3-7 days (in a blinding package)

Treatment:

Drug: Beta-lactam monotherapy

Levofloxacin combination therapy

Experimental group

Description:

Levofloxacin 750 mg IV drip in 90 minutes once daily for 3-7 days (in a blinding package)

Treatment:

Drug: Beta-lactam plus levofloxacin combination therapy