The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy

Skin and Subcutaneous Tissue Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781439
• Other study ID #: 50/CN-HÐÐÐ
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 29, 2020

Study information

• Verified date: March 2021
• Source: Gia Dinh People Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 29, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• on the second day of IV antibiotic

• no difficulties on taking oral medication

• clinical improvement

Exclusion Criteria:

• n/a

Related Conditions & MeSH terms

• Skin and Subcutaneous Tissue Infection
• Skin Diseases, Infectious

Intervention

Procedure:
• IV-to-PO conversion of antibiotics
IV-to-PO switching of antibiotics treatment

Locations

Country	Name	City	State
Vietnam	Gia Dinh people hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gia Dinh People Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of effectiveness	rate of effectiveness of the infection treatment	3 months
Secondary	length of hospital stay	length of hospital stay after starting the antibiotic treatment	3 months
Secondary	length of IV antibiotics	length of IV antibiotics usage	3 months
Secondary	cost of treatment	cost of antibiotics	3 months