BacteremiaPhase 4BLESSNCT07240077
Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia
A Phase 4 study testing Beta-lactam monotherapy and Beta-lactam plus levofloxacin combination therapy in people with Bacteremia and Streptococcus Infection, run by Mahidol University at 4 sites in Thailand.
Trial summary
A double-blind randomized controlled trial comparing beta-lactam plus levofloxacin versus beta-lactam monotherapy for the treatment of Streptococcal bacteremia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia, Streptococcus Infection
- What is being tested?
- Beta-lactam monotherapy and Beta-lactam plus levofloxacin combination therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 4 sitesThailand
- Study dates
- 8 Jan 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known allergy to beta-lactam or fluroquinolone antibiotics
- Pregnancy or lactating mother
- EKG with QT prolongation
- Diagnosis of infective endocarditis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand4 sites, 4 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkok
+6624192707
- Not yet recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
- Recruiting
Maharaj Nakhon Ratchasima
Nakhon Ratchasima
- Not yet recruiting
Ratchburi Hospital
Ratchaburi
About this study
Official title: Beta-lactam Monotherapy Versus Beta-lactam Plus Levofloxacin for the Treatment of Streptococcal Bacteremia: A Multicenter, Randomized, Double-Blind, Pragmatic Trial
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
- Conditions
- Bacteremia, Streptococcus Infection
- Being tested
- Beta-lactam monotherapy, Beta-lactam plus levofloxacin combination therapy
- Keywords
- bacteremia, streptococcus, levofloxacin
- Medical subject headings
- Bacteremia, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-lactam monotherapyDrug
Normal saline placebo
Beta-lactam plus levofloxacin combination therapyDrug
IV Levofloxacin
| Study group | Role | What they receive |
|---|---|---|
| Beta-lactam monotherapy | Placebo comparator | Normal saline 150 cc IV drip in 90 minutes once daily for 3-7 days (in a blinding package) Receives: Drug: Beta-lactam monotherapy |
| Levofloxacin combination therapy | Experimental | Levofloxacin 750 mg IV drip in 90 minutes once daily for 3-7 days (in a blinding package) Receives: Drug: Beta-lactam plus levofloxacin combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days after the onset of infection
Secondary outcomes (1)
Duration of bacteremia
Duration of bacteremia
Measured: 28 days after the onset of infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start8 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinyo Rattanaumpawan, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240077
- Sponsor's protocol ID
- 886/2568(IRB3)
- Acronym
- BLESS
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-lactam Monotherapy Versus Beta-lactam Plus Levofloxacin for the Treatment of Streptococcal Bacteremia: A Multicenter, Randomized, Double-Blind, Pragmatic Trial
- ClinicalTrials.gov ID
- NCT07240077
- Acronym / sponsor ID
- BLESS / 886/2568(IRB3)
- Conditions
- Bacteremia, Streptococcus Infection
- Keywords
- bacteremia, streptococcus, levofloxacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-lactam monotherapy | Placebo comparator | Drug: Beta-lactam monotherapyNormal saline 150 cc IV drip in 90 minutes once daily for 3-7 days (in a blinding package) |
| Levofloxacin combination therapy | Experimental | Drug: Beta-lactam plus levofloxacin combination therapyLevofloxacin 750 mg IV drip in 90 minutes once daily for 3-7 days (in a blinding package) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age>18 years
- Blood culture positive for Streptococcus (<72 hours before enrollment)
- Receiving or having plan of receiving beta-lactam therapy
Key exclusion criteria (4 listed)
- Known allergy to beta-lactam or fluroquinolone antibiotics
- Pregnancy or lactating mother
- EKG with QT prolongation
- Diagnosis of infective endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-lactam monotherapyNormal saline placebo | Drug | Beta-lactam monotherapy |
| Beta-lactam plus levofloxacin combination therapyIV Levofloxacin | Drug | Levofloxacin combination therapy |
Primary outcome
Composite endpointof unfavorable outcome
Time frame: 28 days after the onset of infection
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
1 secondary outcome
Duration of bacteremia
Time frame: 28 days after the onset of infection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-lactam monotherapy and Beta-lactam plus levofloxacin combination therapy in people with Bacteremia and Streptococcus Infection, run by Mahidol University at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pinyo Rattanaumpawan (66897778176, pinyo.rat@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpointof unfavorable outcome (time frame: 28 days after the onset of infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.