The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Skin and Subcutaneous Tissue Infection
• Intervention / Treatment: Procedure: IV-to-PO conversion of antibiotics

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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Gia Dinh People Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• on the second day of IV antibiotic
• no difficulties on taking oral medication
• clinical improvement

Exclusion Criteria:

• n/a

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Gia Dinh People Hospital
• Investigators: Study Director: Dung Nguyen, PhD, Gia Dinh People Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): September 29, 2020

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: effectiveness; antibiotics
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 50/CN-HĐĐĐ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No