A Phase 4 interventional study of Beta-lactam monotherapy and Beta-lactam plus levofloxacin combination therapy in Bacteremia and Streptococcus Infection, sponsored by Mahidol University. Recruiting at 4 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Mahidol University · Phase 4, Interventional, and Treatment
A double-blind randomized controlled trial comparing beta-lactam plus levofloxacin versus beta-lactam monotherapy for the treatment of Streptococcal bacteremia
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
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 165 is close to the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
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Blood culture positive for Streptococcus (\<72 hours before enrollment)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normal saline 150 cc IV drip in 90 minutes once daily for 3-7 days (in a blinding package)
Drug: Beta-lactam monotherapy
Levofloxacin 750 mg IV drip in 90 minutes once daily for 3-7 days (in a blinding package)
Drug: Beta-lactam plus levofloxacin combination therapy
Normal saline placebo
Drug pages: Beta-Lactams · Levofloxacin
IV Levofloxacin
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 infection
Duration of bacteremia
Duration of bacteremia
Time frame: 28 days after the onset of infection
Plan to share: No
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Studies of the drugs tested here: Beta-Lactams · Levofloxacin