Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia

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

• Beta-lactam monotherapy (Drug): Normal saline placebo
• Beta-lactam plus levofloxacin combination therapy (Drug): IV Levofloxacin

Primary outcomes

• 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 outcomes

• Duration of bacteremia [28 days after the onset of infection]: Duration of bacteremia

Sex: All, ages: 18 Years to any

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