NCT04781439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 2, 2021

Last Update Submit

March 3, 2021

Conditions

Skin and Subcutaneous Tissue Infection

Keywords

effectivenessantibiotics

Outcome Measures

Primary Outcomes (1)

  • rate of effectiveness

    rate of effectiveness of the infection treatment

    3 months

Secondary Outcomes (3)

  • length of hospital stay

    3 months

  • length of IV antibiotics

    3 months

  • cost of treatment

    3 months

Study Arms (3)

non-switching

NO INTERVENTION

control group

IV-to-PO conversion within 48-72 hours

EXPERIMENTAL

early switching

Procedure: IV-to-PO conversion of antibiotics

IV-to-PO conversion after 72 hours

EXPERIMENTAL

late switching

Procedure: IV-to-PO conversion of antibiotics

Interventions

IV-to-PO conversion of antibioticsPROCEDURE

IV-to-PO switching of antibiotics treatment

IV-to-PO conversion after 72 hoursIV-to-PO conversion within 48-72 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gia Dinh people hospital

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dung Nguyen, PhD

    Gia Dinh People Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 4, 2021

Study Start

March 1, 2020

Primary Completion

August 30, 2020

Study Completion

September 29, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)