Blood Culture ContaminationNCT05576233
• Comparison of Blood Culture Contamination Rates
A study testing disinfection of the surface that the blood culture is taken in people with Blood Culture Contamination, run by Dr. Behcet Uz Children's Hospital.
Trial summary
In this study, blood culture contamination rates will be compared in patients who used povidine/iodine-alcohol and chlorhexidine/alcohol, which were applied before the blood culture was taken by randomized two methods routinely used in this study. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Blood Culture Contamination
- What is being tested?
- disinfection of the surface that the blood culture is taken
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2023to 1 Dec 2024
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients who will be hospitalized at SBU Izmir Dr. Patients who are hospitalized in the Pediatric Infection Service of Behçet Uz Pediatrics and Surgery Training and Research Hospital, and who will require blood culture indications will participate in the study If they are willing to
Who cannot join
- The patents with central lines will be excluded.
- The patient who were transferred from ICU's will be excluded.
About this study
Official title: Comparison of Blood Culture Contamination Rates Between the Use of Povidine Iodine/Alcohol for Skin Antisepsis and the Use of Chlorhexidine/Alcohol (ChloraPrep) for Skin Antisepsis: An Open-label, Randomized Controlled Trial
In this study, blood culture contamination rates will be compared in patients who used povidine/iodine-alcohol and chlorhexidine/alcohol, which were applied before the blood culture was taken by randomized two methods routinely used in this study.
Read the detailed description
Detection of the pathogen in blood cultures as soon as possible reduces mortality significantly by providing timely initiation of treatment1. However, when skin antisepsis is not performed properly, an increase in the rate of contamination is observed. In this study, it was planned to compare the contamination rate of two antiseptics, povidine iodine/alcohol and Chlorhexidine/alcohol used as skin antisepsis, in the blood culture taken.
Full randomization" will be applied in the study. Multiples of 3 of the patients to be included in the study will be included in the "Chloraprep" group, the remaining patients and multiples of 2 will be included in the "povidine/iodine" group. . According to the number of samples determined for each institution, patients who came to the outpatient clinic during data collection and accepted to participate in the study will be randomly selected.
- Conditions
- Blood Culture Contamination
- Being tested
- disinfection of the surface that the blood culture is taken
- Keywords
- Blood culture contamination, Chloraprep ( alcohol/ chlorhexidine), Povidine/iodine, Topical disinfectants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disinfection of the surface that the blood culture is takenProcedure or surgery
lood cultures can be routinely performed with alcohol/povidine-iodine or alcohol/chlorhexidine. The topical disinfectants used in the two applications are the topical disinfectants included in the guidelines and currently applied in our hospital.
| Study group | Role | What they receive |
|---|---|---|
| 1.The culture taken after disinfection with providing/iodine | Active comparator | 1.Blood cultures routinely performed with alcohol/povidine-iodine Receives: Procedure: disinfection of the surface that the blood culture is taken |
| 2.The culture taken after disinfection with chlorhexidine/alcohol | Active comparator | 2. Blood cultures routinely performed with chlorhexidine/alcohol Receives: Procedure: disinfection of the surface that the blood culture is taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Contamination
The primary endpoint of the study was to reduce the rate of contamination in blood cultures.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start15 Oct 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Culture ContaminationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilker devrim, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576233
- Sponsor's protocol ID
- skin antisepsis study
- Status last verified
- Jan 2023
- First submitted
- 9 Oct 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Culture Contamination Rates Between the Use of Povidine Iodine/Alcohol for Skin Antisepsis and the Use of Chlorhexidine/Alcohol (ChloraPrep) for Skin Antisepsis: An Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05576233
- Acronym / sponsor ID
- skin antisepsis study
- Conditions
- Blood Culture Contamination
- Keywords
- Blood culture contamination, Chloraprep ( alcohol/ chlorhexidine), Povidine/iodine, Topical disinfectants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 12 Oct 2022 (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.
In this study, blood culture contamination rates will be compared in patients who used povidine/iodine-alcohol and chlorhexidine/alcohol, which were applied before the blood culture was taken by randomized two methods routinely used in this study.
Detailed description
Detection of the pathogen in blood cultures as soon as possible reduces mortality significantly by providing timely initiation of treatment1. However, when skin antisepsis is not performed properly, an increase in the rate of contamination is observed. In this study, it was planned to compare the contamination rate of two antiseptics, povidine iodine/alcohol and Chlorhexidine/alcohol used as skin antisepsis, in the blood culture taken.
Full randomization" will be applied in the study. Multiples of 3 of the patients to be included in the study will be included in the "Chloraprep" group, the remaining patients and multiples of 2 will be included in the "povidine/iodine" group. . According to the number of samples determined for each institution, patients who came to the outpatient clinic during data collection and accepted to participate in the study will be randomly selected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.The culture taken after disinfection with providing/iodine | Active comparator | Procedure: disinfection of the surface that the blood culture is taken1.Blood cultures routinely performed with alcohol/povidine-iodine |
| 2.The culture taken after disinfection with chlorhexidine/alcohol | Active comparator | Procedure: disinfection of the surface that the blood culture is taken2. Blood cultures routinely performed with chlorhexidine/alcohol |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients who will be hospitalized at SBU Izmir Dr. Patients who are hospitalized in the Pediatric Infection Service of Behçet Uz Pediatrics and Surgery Training and Research Hospital, and who will require blood culture indications will participate in the study If they are willing to
Key exclusion criteria (2 listed)
- The patents with central lines will be excluded.
- The patient who were transferred from ICU's will be excluded.
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 |
|---|---|---|
| disinfection of the surface that the blood culture is takenlood cultures can be routinely performed with alcohol/povidine-iodine or alcohol/chlorhexidine. The topical disinfectants used in the two applications are the topical disinfectants included in the guidelines and currently applied in our hospital. | Procedure or surgery | 1.The culture taken after disinfection with providing/iodine, 2.The culture taken after disinfection with chlorhexidine/alcohol |
Primary outcome
Blood Contamination
Time frame: 14 days
The primary endpoint of the study was to reduce the rate of contamination in blood cultures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Related trials for Blood Culture Contamination
Active, not recruiting
Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)
Blood Culture Contamination, Infection
RecruitingObservational study
Impact of Blood Cultures Drawn From Arterial Lines on the Incidence of Contamination, Detection of Bacteremia, and Blood Culture Volume
Bacteremia
Active, not recruiting
Blood Culture Collection Strategies for Suspected Bloodstream Infection
Bacteremia and Sepsis, Bloodstream Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing disinfection of the surface that the blood culture is taken in people with Blood Culture Contamination, run by Dr. Behcet Uz Children's Hospital.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Blood Contamination (time frame: 14 days). 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 1 Feb 2023.