Actively Recruiting
Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia: The EVOS Randomized Controlled Trial
Led by Clinical Research Centre, Malaysia · Updated on 2024-07-05
290
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an early switch from intravenous (IV) to oral antibiotic treatment in patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). This phase 3, randomized, open-label trial compares early oral antibiotic switch therapy to the standard IV antibiotic regimen. The study tests whether switching early to oral antibiotics is as safe and effective as the conventional minimum 14-day IV therapy in patients considered low-risk for complicated SAB. Participants who have received 3 to 7 days of IV antibiotics and meet eligibility criteria are randomly assigned to one of two groups. One group switches early to oral antibiotics for 7 to 11 days to complete a total 14-day antimicrobial course, using medications like trimethoprim-sulfamethoxazole, clindamycin, cephalexin, or linezolid depending on bacterial susceptibility. The other group continues IV antibiotics such as cloxacillin, cefazolin, vancomycin, or ceftaroline for 7 to 11 days to complete the same 14-day total. The treatment choices are guided by susceptibility and clinical factors. Each participant undergoes screening and enrollment followed by open-label treatment lasting about 7 to 11 days, then is monitored for up to 90 days after randomization. Follow-up includes phone or inpatient visits at days 7-11, 30, and 90 to assess condition and safety. Researchers measure relapse rates of SAB within 90 days as the primary outcome, along with hospitalization length, mortality, IV therapy complications, Clostridium difficile diarrhea, and adverse events.
CONDITIONS
Brief Title
Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Blood culture positive for Staphylococcus aureus (S. aureus).
- Received 3 to 7 days of definitive intravenous antimicrobial therapy with appropriate dosing.
- Achieved clearance of bacteraemia with at least one negative follow-up blood culture within 72 hours after starting IV therapy.
- Achieved defervescence with body temperature below 37.56C within 48 hours before randomization.
- Able to provide written informed consent to participate in the trial.
You will not qualify if you...
- Evidence of metastatic Staphylococcus aureus infection such as infective endocarditis, abscess, empyema, or osteomyelitis.
- Septic shock requiring vasopressors to maintain blood pressure.
- Received more than 5 days of non-study antibiotics before enrollment.
- Polymicrobial bloodstream infection with pathogens other than S. aureus.
- History of S. aureus infection within the past 3 months.
- Inability to take oral therapy or unsuitable for ongoing IV therapy.
- No available oral antibiotic options due to resistance, contraindications, or drug unavailability.
- Concurrent use of oral antibiotics active against S. aureus.
- Presence of non-removable foreign body devices such as prosthetic heart valves or pacemakers.
- Failure or inability to remove intravascular catheter present at first positive blood culture.
- Comorbidities increasing complicated infection risk including end-stage renal disease, severe liver disease, severe immunodeficiency, recent transplantation, or neutropenia.
- Life expectancy less than 3 months.
- Pregnancy for women of childbearing potential.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 7 to 11 days
Participants receive either early oral antibiotic therapy or continued intravenous antibiotic therapy for 7 to 11 days to complete a total of 14 days of definitive antimicrobial treatment for Staphylococcus aureus bacteraemia.
1 to 2 visits (phone call or inpatient) during treatment period
Duration - Up to 90 days post-randomization
Participants are followed up to monitor their condition and assess outcomes after completing treatment.
Follow-up visits or calls at Day 30 and Day 90 post-randomization
Trial Site Locations
Total: 12 locations
1
Hospital Sultanah Aminah
Johor Bahru, Johor, Malaysia, 80100
Actively Recruiting
2
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia, 05460
Actively Recruiting
3
Hospital Sultan Abdul Halim
Sungai Petani, Kedah, Malaysia, 08000
Actively Recruiting
4
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, Malaysia, 70300
Actively Recruiting
5
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia, 30450
Actively Recruiting
6
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia, 10450
Actively Recruiting
7
Hospital Seberang Jaya
Seberang Jaya, Pulau Pinang, Malaysia, 13700
Actively Recruiting
8
Hospital Ampang
Ampang, Selangor, Malaysia, 68000
Actively Recruiting
9
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, Malaysia, 43000
Actively Recruiting
10
Hospital Tengku Ampuan Rahimah
Klang, Selangor, Malaysia, 41200
Actively Recruiting
11
Hospital Selayang
Selayang Baru Utara, Selangor, Malaysia, 68100
Actively Recruiting
12
Hospital Melaka
Malacca, Malaysia, 75400
Actively Recruiting
Research Team
S
Steven Lim, MBBS, MRCP
J
Josephine P Durai, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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