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.
The study is conducted at 12 government tertiary hospitals with infectious diseases physicians in Malaysia. The study population comprises of 290 patients with uncomplicated SAB who have received 3 to 7 days of definitive IV antimicrobial therapy. Eligible participants are randomized 1:1 into 2 groups, early oral antibiotic switch versus standard IV antibiotic therapy, following the inclusion and exclusion criteria. The study consists of 3 stages for each patient with a duration of approximately 12 weeks: screening and enrolment, open-label treatment with 7 to 11 days of study antibiotics, and follow-up until day 90 post-randomization. Phone call or inpatient follow up will be conducted at Day 7-11, Day 30, and Day 90 post- randomization to review patient's condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
The choice of study drug will depend on the susceptibility of the respective isolate, expected drug interactions, contraindications, and expected side effects. Investigators will assess whether the "first-choice" regimen can be given and then consider the alternative regimen. The antibiotics can be switched from first choice to the respective alternative medications during the intervention period if clinically necessary. The route of administration must be maintained according to the randomized group.
The choice of study drug will depend on the susceptibility of the respective isolate, expected drug interactions, contraindications, and expected side effects. Investigators will assess whether the "first-choice" regimen can be given and then consider the alternative regimen. The antibiotics can be switched from first choice to the respective alternative medications during the intervention period if clinically necessary. The route of administration must be maintained according to the randomized group.
Hospital Sultanah Aminah
Johor Bahru, Johor, Malaysia
RECRUITINGHospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
RECRUITINGHospital Sultan Abdul Halim
Sungai Petani, Kedah, Malaysia
RECRUITINGHospital Tuanku Ja'afar
Seremban, Negeri Sembilan, Malaysia
RECRUITINGHospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
RECRUITINGHospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
RECRUITINGHospital Seberang Jaya
Seberang Jaya, Pulau Pinang, Malaysia
RECRUITINGHospital Ampang
Ampang, Selangor, Malaysia
RECRUITINGHospital Sultan Idris Shah Serdang
Kajang, Selangor, Malaysia
RECRUITINGHospital Tengku Ampuan Rahimah
Klang, Selangor, Malaysia
RECRUITING...and 2 more locations
Rate of SAB-relapse
defined as any new positive blood culture with S. aureus, and/or newly diagnosed metastatic S. aureus infection resulting from hematogenous dissemination
Time frame: 90 days
Number of days of hospitalization
Number of calendar days of hospitalisation after the first positive blood culture for S. aureus.
Time frame: 90 days
Rate of all-cause mortality
Any death occurred within 90 days of randomization.
Time frame: 90 days
Rate of complications related to IV therapy
Any complications related to insertion or usage of peripheral branula or central catheter, and administration of IV drugs
Time frame: 90 days
Rate of Clostridium difficile diarrhoea
A diagnosis of diarrhoea with ≥1 stool sample tested positive for C. difficile toxin or toxin gene.
Time frame: 90 days
Rate of adverse events
Any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have a causal relationship with treatment.
Time frame: 30 days
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