ClinicalTrials.gg
RecruitingNCT07240077BLESSUpdated Aug 21, 2026

Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia

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

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Bacteremia
  • Streptococcus Infection

Keywords

  • bacteremia
  • streptococcus
  • levofloxacin
03

In context

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 →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Known allergy to beta-lactam or fluroquinolone antibiotics
  2. Pregnancy or lactating mother
  3. with
  4. Diagnosis of infective endocarditis
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
165 participants (estimated)

Study arms

  • Placebo comparator
    Beta-lactam monotherapy

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

    Drug: Beta-lactam monotherapy

  • Experimental
    Levofloxacin combination therapy

    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

Interventions

  • DrugBeta-lactam monotherapy

    Normal saline placebo

  • DrugBeta-lactam plus levofloxacin combination therapy

    Drug pages: Beta-Lactams · Levofloxacin

    IV Levofloxacin

06

What researchers measure

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 infection

Secondary outcomes

  1. Duration of bacteremia

    Duration of bacteremia

    Time frame: 28 days after the onset of infection

07

Study locations

2 of 4 sites recruiting
  • Faculty of Medicine Siriraj Hospital
    Bangkok, Thailand
    Recruiting
    • · Contact+6624192707
  • Maharaj Nakorn Chiang Mai Hospital
    Chiang Mai, Thailand
    Not yet recruiting
  • Maharaj Nakhon Ratchasima
    Nakhon Ratchasima, Thailand
    Recruiting
  • Ratchburi Hospital
    Ratchaburi, Thailand
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07240077
Lead sponsor
Mahidol University
Responsible party
Pinyo Rattanaumpawan (Professor, Mahidol University) — Principal investigator
First posted
Nov 20, 2025
Start date
Jan 8, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Pinyo Rattanaumpawan
Contact
pinyo.rat@mahidol.ac.th
66897778176
Wanwisa Chanapai
Contact
wanwisa.cha@mahidol.ac.th
6624197000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drugs tested here: Beta-Lactams · Levofloxacin

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