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New treatment option for Staphylococcus Aureus Bacteremia
Official title Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia
ClinicalTrials.gov ID: NCT06336824
What this study is testing
What is Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid?
Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for staphylococcus aureus bacteremia.
Also referred to as Bactrim, Dalacin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Blood culture positive for Staphylococcus aureus (S. aureus).
- Received 3 to 7 days of definitive IV antimicrobial therapy, defined as:
- Cloxacillin or cefazolin for methicillin-sensitive staphylococcus aureus (MSSA); Vancomycin or ceftaroline for methicillin-resistant staphylococcus...
- Proven in-vitro susceptibility and adequate dosing given (as determined by the principal investigator).
- Achieved clearance of bacteraemia, defined as at least one documented latest negative follow-up blood culture obtained within 72 hours after the...
You likely can't join if
- Evidence of metastatic infection of S. aureus: for example, infective endocarditis, intraabdominal abscess, lung empyema, and osteomyelitis...
- Septic shock, defined as hypotension requiring vasopressors to maintain MAP ≥65 mmHg despite adequate volume resuscitation.
- Received more than 5 days of non-study antibiotics as empirical therapy prior to enrolment.
- Polymicrobial bloodstream infection, defined as isolation of pathogens other than S. aureus from a blood culture obtained prior to randomization...
- Known history of S. aureus infection within the past 3 months.
- Inability to tolerate oral therapy or poor absorption of oral medications, or not suitable for ongoing IV therapy (for example, difficult intravenous...
See the full eligibility criteria
- Blood culture positive for Staphylococcus aureus (S. aureus).
- Received 3 to 7 days of definitive IV antimicrobial therapy, defined as:
- Cloxacillin or cefazolin for methicillin-sensitive staphylococcus aureus (MSSA); Vancomycin or ceftaroline for methicillin-resistant staphylococcus aureus (MRSA).
- Proven in-vitro susceptibility and adequate dosing given (as determined by the principal investigator).
- Achieved clearance of bacteraemia, defined as at least one documented latest negative follow-up blood culture obtained within 72 hours after the initiation of definitive IV antimicrobial therapy.
- Achieved defervescence, defined as sustained body temperature ≤37.5°C within 48 hours before randomization.
- Able to provide written informed consent to participate trial.
- Evidence of metastatic infection of S. aureus: for example, infective endocarditis, intraabdominal abscess, lung empyema, and osteomyelitis. Radiological investigations such as chest X-ray, ultrasound, echocardiogram...
- Septic shock, defined as hypotension requiring vasopressors to maintain MAP ≥65 mmHg despite adequate volume resuscitation.
- Received more than 5 days of non-study antibiotics as empirical therapy prior to enrolment.
- Polymicrobial bloodstream infection, defined as isolation of pathogens other than S. aureus from a blood culture obtained prior to randomization. Common skin contaminants such as coagulase-negative staphylococci...
- Known history of S. aureus infection within the past 3 months.
- Inability to tolerate oral therapy or poor absorption of oral medications, or not suitable for ongoing IV therapy (for example, difficult intravenous access)
- No options of oral antibiotic available for patient due to:
- In vitro resistance of S. aureus to all oral study drugs.
- Known contraindications to receive the active oral study drugs. For example, hypersensitivity reaction to trimethoprim-sulfamethoxazole, thrombocytopenia secondary to linezolid etc.
- Non-availability of oral study drugs at the study sites.
- Patient is concomitantly receiving oral antibiotics which are active against S. aureus. For example, trimethoprim-sulfamethoxazole for Pneumocystis jirovecii pneumonia prophylaxis.
- Presence of a non-removable foreign body such as prosthetic heart valve, vascular graft, pacemaker, automated implantable cardioverter-defibrillator, ventriculoperitoneal shunt, prosthetic joint, and fracture fixation...
- Failure or inability to remove intravascular catheter that is present when first positive blood culture was drawn.
- Known comorbidity that increased the risk of complicated infections:
- End-stage renal disease
- Severe liver disease (Child-Pugh class C)
- Severe immunodeficiency:
- HIV-positive patients with CD4\<200 cells/uL or AIDS
- primary immunodeficiency disorders
- high-dose steroid therapy (\>1 mg/kg prednisone or equivalent doses given for \> 4 weeks or planned during intervention)
- immunosuppressive therapy
- neutropenia (\<500 neutrophils/μl) at randomization or neutropenia expected during intervention phase due to immunosuppressive treatment
- solid organ or hematopoietic stem cell transplantation within the past 6 months or planned during treatment period 13.Short life expectancy \< 3 months 14.Pregnancy (for women of childbearing potential)
The study team makes the final eligibility decision.
Where it's taking place
- Johor Bahru, Johor, Malaysia
- Alor Star, Kedah, Malaysia
- Sungai Petani, Kedah, Malaysia
- Seremban, Negeri Sembilan, Malaysia
- Ipoh, Perak, Malaysia
- George Town, Pulau Pinang, Malaysia
- Seberang Jaya, Pulau Pinang, Malaysia
- Ampang, Selangor, Malaysia
- Kajang, Selangor, Malaysia
- Klang, Selangor, Malaysia
- Selayang Baru Utara, Selangor, Malaysia
- Malacca, Malaysia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Johor Bahru, Johor, Malaysia; Alor Star, Kedah, Malaysia; Sungai Petani, Kedah, Malaysia; Seremban, Negeri Sembilan, Malaysia; Ipoh, Perak, Malaysia; George Town, Pulau Pinang, Malaysia and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.