Actively Recruiting
Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia
Led by Clinical Research Centre, Malaysia · Updated on 2024-07-05
290
Participants Needed
12
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 IV antimicrobial therapy with appropriate antibiotics for MSSA or MRSA.
- Proven in-vitro susceptibility and adequate dosing given.
- Clearance of bacteraemia confirmed by at least one negative follow-up blood culture within 72 hours after starting definitive IV therapy.
- Sustained body temperature below 37.5�b0C within 48 hours before randomization.
- Able to provide written informed consent.
You will not qualify if you...
- Evidence of metastatic Staphylococcus aureus infection such as infective endocarditis, intraabdominal abscess, lung empyema, or osteomyelitis.
- Septic shock requiring vasopressors to maintain MAP 65 mmHg despite resuscitation.
- More than 5 days of non-study antibiotics as empirical therapy before enrollment.
- Polymicrobial bloodstream infection excluding common skin contaminants.
- Known history of Staphylococcus aureus infection within the past 3 months.
- Inability to tolerate oral therapy, poor oral absorption, or unsuitable for ongoing IV therapy.
- No available oral antibiotic options due to resistance, contraindications, or drug unavailability.
- Concomitant use of oral antibiotics active against Staphylococcus aureus.
- Presence of non-removable foreign body implants like prosthetic heart valves or pacemakers.
- Failure or inability to remove intravascular catheter present at first positive blood culture.
- Comorbidities increasing risk of complicated infections including end-stage renal disease, severe liver disease (Child-Pugh class C), severe immunodeficiency conditions, or recent organ transplantation.
- Short life expectancy less than 3 months.
- Pregnancy in women of childbearing potential.
AI-Screening
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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
CONTACT
J
Josephine P Durai, MBBS
CONTACT
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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