Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University
About this trial
A double-blind randomized controlled trial comparing beta-lactam plus levofloxacin versus beta-lactam monotherapy for the treatment of Streptococcal bacteremia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known allergy to beta-lactam or fluroquinolone antibiotics
Pregnancy or lactating mother
EKG with QT prolongation
Diagnosis of infective endocarditis
Trial design
Design model
Parallel
Treatments tested in this trial
Beta-lactam monotherapy
DrugNormal saline placebo
Beta-lactam plus levofloxacin combination therapy
DrugIV Levofloxacin
Treatment groups
165 Participants
are divided into 2 treatment groupsGroup A: Beta-lactam monotherapyPlacebo comparator 1 intervention
Group B: Levofloxacin combination therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Composite endpointof unfavorable outcome
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
Time frame
28 days after the onset of infectionSecondary outcomes
1
Duration of bacteremia
Duration of bacteremia
Time frame
28 days after the onset of infectionSponsors and contacts
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Source ClinicalTrials.gov