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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-lactam monotherapy | Placebo Comparator | Normal saline 150 cc IV drip in 90 minutes once daily for 3-7 days (in a blinding package) |
|
| Levofloxacin combination therapy | Experimental | Levofloxacin 750 mg IV drip in 90 minutes once daily for 3-7 days (in a blinding package) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-lactam monotherapy | Drug | Normal saline placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days after the onset of infection |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of bacteremia | Duration of bacteremia | 28 days after the onset of infection |
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Inclusion Criteria:
Adults age>18 years
Blood culture positive for Streptococcus (<72 hours before enrollment)
Receiving or having plan of receiving beta-lactam therapy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pinyo Rattanaumpawan | Contact | 66897778176 | pinyo.rat@mahidol.ac.th | |
| Wanwisa Chanapai | Contact | 6624197000 | wanwisa.cha@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital | Bangkok | Thailand |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| ID | Term |
|---|---|
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
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| Beta-lactam plus levofloxacin combination therapy |
| Drug |
IV Levofloxacin |
|
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand |
| Maharaj Nakhon Ratchasima | Nakhon Ratchasima | Thailand |
| Ratchburi Hospital | Ratchaburi | Thailand |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |