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Oral Step-down Therapy in SAB

Efficacy of Oral Cephalexin or Levofloxacin Step-Down Therapy After 7 Days of Intravenous Antibiotic Treatment Compared with 14-Day Intravenous Antibiotic Therapy in MSSA Septicemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260505010
Enrollment
104
Registered
2026-05-05
Start date
2026-04-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-risk Staphylococcus aureus bacteremia Staphylococcus aureus bacteremia Cephalexin Levofloxacin Oral switch therapy

Interventions

Oral switch to cephalexin or levofloxacin (CrCl-adjusted dose) after 7 days of intravenous antibiotic Total duration of treatment 14 days starting from first documented negative hemoculture,14 days of
Experimental Drug,Active Comparator Drug
Oral switch,Standard IV

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with MSSA bloodstream infection with a low risk of complications, who must have at least one blood culture specimen positive for MSSA. 2. Patients must receive appropriate antibiotic therapy within no more than 72 hours from the time the first blood sample that later yielded a positive culture was collected. In this context, antibiotics considered appropriate for treating MSSA include Penicillinase-resistant penicillins, such as flucloxacillin, cloxacillin, beta-lactam plus beta-lactamase inhibitor agents, such as ampicillin-sulbactam, piperacillin-tazobactam, All cephalosporins except ceftazidime, All carbapenems, All fluoroquinolones, Tetracyclines, such as doxycycline, tigecycline, Glycopeptides, such as vancomycin, teicoplanin, telavancin, Clindamycin, Trimethoprim-sulfamethoxazole, Linezolid, Daptomycin, Macrolides 3. Patients must have a negative follow-up blood culture after receiving appropriate treatment for 24-96 hours.

Exclusion criteria

Exclusion criteria: 1. Patients who have symptoms or signs of deep-seated MSSA infection before entering the randomization process, defined as the following conditions (Endocarditis, Pneumonia, Infected implant, Osteomyelitis, Undrained abscess, Empyema) 2. Patients who still have septic shock during the 4 days before entering the randomization process. 3. Patients with persistent fever, defined as a measured body temperature of 38 C or higher during the 2 days before entering the randomization process. 4. Patients with persistent bacteremia, with blood cultures positive for MSSA despite having received appropriate antibiotic therapy for at least 72 hours. 5. Patients who have an intravascular catheter left in place for more than 4 days from the date of the first positive culture, in cases of catheter-related MSSA bloodstream infection (catheter-related bloodstream infection). 6. Patients who are likely to develop complications from MSSA bloodstream infection, including 6.1 Patients previously diagnosed with MSSA bloodstream infection within the past 3 months 6.2 Patients with underlying diseases or medical treatments causing severe immunocompromised conditions, including primary immunodeficiency disorders, neutropenia, with an absolute neutrophil count (ANC) less than 500 cells/cu.mm. before entering the randomization process, or expected to develop neutropenia during the study 6.3 People living with HIV with a CD4 lymphocyte count less than 200 cells/cu.mm. 6.4 Patients receiving prednisolone more than 1 MKD (or equivalent) for at least 4 weeks, or planning to start such steroid therapy during the study 6.5 Patients receiving at least two immunosuppressive agents with different immunosuppressive mechanisms of action 6.6 Patients who have undergone hematopoietic stem cell transplantation within the past 6 months, or are likely to undergo transplantation during the study 6.7 Patients who have undergone solid organ transplantation, or are likely to undergo transplantation during the study Patients who have received biologic therapy within the past year 6.8 Intravenous drug users (IVDU) 6.9 Patients with a prosthetic heart valve and/or a deep-seated vascular graft in the body 7. Patients with other concurrent infections (co-infection) during the same period.

Design outcomes

Primary

MeasureTime frame
Composite outcome 30 days mortality rate, treatment failure rate

Secondary

MeasureTime frame
mortality rate 30 days mortality rate,deep-seated infection 30 days occurrence of deep-seated infection,bacteremia 30 days relapse of bacteremia,safety outcome 30 days adverse events during treatment

Countries

Thailand

Contacts

Public ContactNatthapong Suthammopasut

Faculty of Medicine, Chiang Mai University

natthapongtitle@gmail.com0987415569

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026