Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336824
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-22
Brief Title:
Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia
Sponsor:
Clinical Research Centre Malaysia
Organization:
Clinical Research Centre Malaysia
Study Overview
Official Title:
Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia The EVOS Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVOS
Brief Summary:
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
Detailed Description:
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 11 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 patients condition
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 patients condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None