Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-12-31

Brief Summary

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

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Detailed Description

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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

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Bacteremia Streptococcus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Beta-lactam monotherapy

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

Group Type PLACEBO_COMPARATOR

Beta-lactam monotherapy

Intervention Type DRUG

Normal saline placebo

Levofloxacin combination therapy

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

Group Type EXPERIMENTAL

Beta-lactam plus levofloxacin combination therapy

Intervention Type DRUG

IV Levofloxacin

Interventions

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Beta-lactam monotherapy

Normal saline placebo

Intervention Type DRUG

Beta-lactam plus levofloxacin combination therapy

IV Levofloxacin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No