NCT07240077

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: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bacteremia
• Streptococcus Infection

Interventions

Type	Name	Description
DRUG	Beta-lactam monotherapy	Normal saline placebo
DRUG	Beta-lactam plus levofloxacin combination therapy	IV Levofloxacin

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

4 sites across 1 country: Thailand