RecruitingPhase 3NCT06336824

Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia

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


Sponsor

Clinical Research Centre, Malaysia

Enrollment

290 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline and a drug called Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid for people with staphylococcus aureus bacteremia. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTab. 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.

DRUGIV 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

View Full Details on ClinicalTrials.gov

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NCT06336824


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