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RECRUITING
NCT06336824
PHASE3

Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia

Sponsor: Clinical Research Centre, Malaysia

View on ClinicalTrials.gov

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.

Official title: Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia: The EVOS Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2024-06-28

Completion Date

2025-06

Last Updated

2024-07-05

Healthy Volunteers

No

Interventions

DRUG

Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid

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.

DRUG

IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline

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.

Locations (12)

Hospital Sultanah Aminah

Johor Bahru, Johor, Malaysia

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Hospital Sultan Abdul Halim

Sungai Petani, Kedah, Malaysia

Hospital Tuanku Ja'afar

Seremban, Negeri Sembilan, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, Malaysia

Hospital Ampang

Ampang, Selangor, Malaysia

Hospital Sultan Idris Shah Serdang

Kajang, Selangor, Malaysia

Hospital Tengku Ampuan Rahimah

Klang, Selangor, Malaysia

Hospital Selayang

Selayang Baru Utara, Selangor, Malaysia

Hospital Melaka

Malacca, Malaysia