Skin and Subcutaneous Tissue InfectionNCT04781439
The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy
A study testing IV-to-PO conversion of antibiotics in people with Skin and Subcutaneous Tissue Infection, run by Gia Dinh People Hospital at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin and Subcutaneous Tissue Infection
- What is being tested?
- IV-to-PO conversion of antibiotics
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2020to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on the second day of IV antibiotic
- no difficulties on taking oral medication
- clinical improvement
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin and Subcutaneous Tissue Infection
- Being tested
- IV-to-PO conversion of antibiotics
- Keywords
- effectiveness, antibiotics
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV-to-PO conversion of antibioticsProcedure or surgery
IV-to-PO switching of antibiotics treatment
| Study group | Role | What they receive |
|---|---|---|
| non-switching | No intervention | control group |
| IV-to-PO conversion within 48-72 hours | Experimental | early switching Receives: Procedure: IV-to-PO conversion of antibiotics |
| IV-to-PO conversion after 72 hours | Experimental | late switching Receives: Procedure: IV-to-PO conversion of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of effectiveness
rate of effectiveness of the infection treatment
Measured: 3 months
Secondary outcomes (3)
length of hospital stay
length of hospital stay after starting the antibiotic treatment
Measured: 3 months
length of IV antibiotics
length of IV antibiotics usage
Measured: 3 months
cost of treatment
cost of antibiotics
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Mar 2020
- Primary completion30 Aug 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin and Subcutaneous Tissue InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dung Nguyen, PhD, Study director, Gia Dinh People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781439
- Sponsor's protocol ID
- 50/CN-HĐĐĐ
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04781439
- Acronym / sponsor ID
- 50/CN-HĐĐĐ
- Conditions
- Skin and Subcutaneous Tissue Infection
- Keywords
- effectiveness, antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-switching | No intervention | –control group |
| IV-to-PO conversion within 48-72 hours | Experimental | Procedure: IV-to-PO conversion of antibioticsearly switching |
| IV-to-PO conversion after 72 hours | Experimental | Procedure: IV-to-PO conversion of antibioticslate switching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- on the second day of IV antibiotic
- no difficulties on taking oral medication
- clinical improvement
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV-to-PO conversion of antibioticsIV-to-PO switching of antibiotics treatment | Procedure or surgery | IV-to-PO conversion after 72 hours, IV-to-PO conversion within 48-72 hours |
Primary outcome
rate of effectiveness
Time frame: 3 months
rate of effectiveness of the infection treatment
3 secondary outcomes
length of hospital stay
Time frame: 3 months
length of IV antibiotics
Time frame: 3 months
cost of treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dung Nguyen, PhD study director
Gia Dinh People Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV-to-PO conversion of antibiotics in people with Skin and Subcutaneous Tissue Infection, run by Gia Dinh People Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of effectiveness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.