Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Beta-lactam monotherapy, Beta-lactam plus levofloxacin combination therapy.
- Who it may be relevant to
- Registry conditions: Bacteremia, Streptococcus Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Beta-lactam Monotherapy Versus Beta-lactam Plus Levofloxacin for the Treatment of Streptococcal Bacteremia: A Multicenter, Randomized, Double-Blind, Pragmatic Trial
Overview
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
Interventions
- Drug Beta-lactam monotherapy
Normal saline placebo - Drug Beta-lactam plus levofloxacin combination therapy
IV Levofloxacin
Primary outcome measures
- Composite endpointof unfavorable outcome [Time frame: 28 days after the onset of infection]
Secondary outcome measures (1)
- Duration of bacteremia [Time frame: 28 days after the onset of infection]
Eligibility criteria
Inclusion criteria
- Adults age>18 years
- 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
- Receiving or having plan of receiving beta-lactam therapy
Exclusion criteria
- Known allergy to beta-lactam or fluroquinolone antibiotics
- Pregnancy or lactating mother
- EKG with QT prolongation
- Diagnosis of infective endocarditis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Thailand · 4 centers
- Faculty of Medicine Siriraj Hospital — Bangkok
- Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
- Maharaj Nakhon Ratchasima — Nakhon Ratchasima
- Ratchburi Hospital — Ratchaburi
Identifiers
NCT: NCT07240077 · 886/2568(IRB3)