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

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

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

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