The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy

Study Overview
=================
Brief Summary
-----------------
To date, many studies showed the great benefits of switching from IV to PO antibiotics in some infectious diseases, especially skin and soft tissue, urinary tract, respiratory tract, gallbladder, and biliary tract infection. Higher level of evidence is necessary to confirm the benefit of early switching protocol in infectious condition management. Therefore, we conducted a clinical trial to investigate the effectiveness and cost of IV-to-PO antibiotic switch therapy in some surgical infection conditions.

Detailed Description
-----------------
Introduction: The benefit of early switching from intravenous (IV) to oral (PO)was raising from the last decade. This randomized clinical trial was to evaluate the effect of early switching from IV to PO antibiotics on the outcome of surgical patients at a public hospital. Methods: Patients admitted for a therapeutic antibiotic to orthopedic and general surgery conditions were randomly assigned to three groups: control (non-switching), early switching (within 48-72 hours), and late switching (after 72 hours). The rate of effectiveness of each arm, length of hospital stay, length of IV antibiotics, and cost were recorded prospectively.

Official Title
-----------------
The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy: a Randomized Control Trial

Conditions
-----------------
Skin and Subcutaneous Tissue Infection

Intervention / Treatment
-----------------
* Procedure: IV-to-PO conversion of antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: on the second day of IV antibiotic no difficulties on taking oral medication clinical improvement Exclusion Criteria: n/a

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: non-switching<br>control group | |
| Experimental: IV-to-PO conversion within 48-72 hours<br>early switching | Procedure: IV-to-PO conversion of antibiotics<br>* IV-to-PO switching of antibiotics treatment<br>|
| Experimental: IV-to-PO conversion after 72 hours<br>late switching | Procedure: IV-to-PO conversion of antibiotics<br>* IV-to-PO switching of antibiotics treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of effectiveness | rate of effectiveness of the infection treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | length of hospital stay after starting the antibiotic treatment | 3 months | 
| length of IV antibiotics | length of IV antibiotics usage | 3 months | 
| cost of treatment | cost of antibiotics | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
effectiveness, antibiotics