Beta-lactam plus levofloxacin for streptococcal bacteremia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind study, adults with positive Streptococcus blood cultures who are on intravenous beta-lactam therapy are assigned to receive either intravenous levofloxacin or a saline placebo for 3 to 7 days, with dosing adjusted for kidney function. The primary outcome is a composite of unfavorable events, and the secondary outcome is the duration of bacteremia. Participants are enrolled at multiple sites and randomized with stratification by site to ensure balanced groups. The study aims to determine if adding levofloxacin improves treatment effectiveness beyond beta-lactam monotherapy. Safety considerations include monitoring for antibiotic-related adverse effects and drug interactions.

Why it matters

Who can join: the full rules

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

Where it's running

• Faculty of Medicine Siriraj Hospital
  Bangkok, Thailand Recruiting
• Maharaj Nakhon Ratchasima
  Nakhon Ratchasima, Thailand Recruiting
• Maharaj Nakorn Chiang Mai Hospital
  Chiang Mai, Thailand Not yet recruiting
• Ratchburi Hospital
  Ratchaburi, Thailand Not yet recruiting

Study contacts

• Study coordinator: Pinyo Rattanaumpawan
• Email: pinyo.rat@mahidol.ac.th
• Phone: 66897778176

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.