BacteremiaPhase 4NCT01919593
Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children
A Phase 4 study testing 2% chlorhexidine gluconate in 70% alcohol and 10%povidone iodine in people with Bacteremia, run by Thammasat University at 1 site in Thailand.
Trial summary
To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Bacteremia
- What is being tested?
- 2% chlorhexidine gluconate in 70% alcohol and 10%povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,269 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 4
- 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 day to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit. Patients who needed percutaneous blood cultures were eligible for enrollment.
Who cannot join
- Preterm infant
- Patient who had skin infection at site of venepuncture
- Patient who had history allergy to 2% Chlorhexidine gluconate in 70% alcohol or 10% povidone-iodine
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University hospital
Klong Luang, Pathumthanii, 10900
About this study
Official title: The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients
To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients.
Read the detailed description
This is a prospective study of pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit at a tertiary-care teaching hospital. Patients who needed percutaneous blood cultures were eligible for enrollment and were classified into two groups according to antiseptic used: 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months. Blood cultures were taken primarily by ward nurses using standard technique. The blood cultures were analysed and monitored for 5 days. Isolated organisms and their antimicrobial susceptibilities were determined using standard microbiologic techniques.
Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data. A blood culture was classified as contaminated if common skin flora such as Coagulase negative staphylococci, Corynebacterium spp., Micrococcus spp., or Bacillus spp. were isolated from one of the blood culture samples without isolation of the same organism from another potential infection site (for example, intravenous catheter), or a common skin flora was isolated in a patient with incompatible clinical features and improved without specific treatment for that organism.
- Conditions
- Bacteremia
- Being tested
- 2% chlorhexidine gluconate in 70% alcohol, 10%povidone iodine
- Keywords
- Blood culture, Contamination, Chlorhexidine gluconate, Povidone iodine
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine gluconate in 70% alcoholDrug
Also called Chloraprep
skin preparation before venipuncture for blood culture in even month
10%povidone iodineDrug
Also called Betadine
skin preparation before venipuncture for blood culture in odd month
| Study group | Role | What they receive |
|---|---|---|
| 2% Chlorhexidine Gluconate | Experimental | apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture Receives: Drug: 2% chlorhexidine gluconate in 70% alcohol |
| 10% povidone iodine | Active comparator | apply 10% povidone iodine on the skin before venipuncture Receives: Drug: 10%povidone iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
Pediatric patients who needed percutaneous blood cultures were recruited and were assigned 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months as an antiseptic for blood cultures. Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data.
Measured: 5 days
Secondary outcomes (1)
safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
direct observe skin reaction after use both antiseptics
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Auchara Tangsathapornpong, Thammasat University
- Investigators
- Auchara Tangsathapornponng, MD, Principal investigator, Faculty of Medicine, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919593
- Sponsor's protocol ID
- MTU-PE-3-053/55
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01919593
- Acronym / sponsor ID
- MTU-PE-3-053/55
- Conditions
- Bacteremia
- Keywords
- Blood culture, Contamination, Chlorhexidine gluconate, Povidone iodine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,269 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Aug 2013 (estimated)
- 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 evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients.
Detailed description
This is a prospective study of pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit at a tertiary-care teaching hospital. Patients who needed percutaneous blood cultures were eligible for enrollment and were classified into two groups according to antiseptic used: 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months. Blood cultures were taken primarily by ward nurses using standard technique. The blood cultures were analysed and monitored for 5 days. Isolated organisms and their antimicrobial susceptibilities were determined using standard microbiologic techniques.
Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data. A blood culture was classified as contaminated if common skin flora such as Coagulase negative staphylococci, Corynebacterium spp., Micrococcus spp., or Bacillus spp. were isolated from one of the blood culture samples without isolation of the same organism from another potential infection site (for example, intravenous catheter), or a common skin flora was isolated in a patient with incompatible clinical features and improved without specific treatment for that organism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Chlorhexidine Gluconate | Experimental | Drug: 2% chlorhexidine gluconate in 70% alcoholapply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture |
| 10% povidone iodine | Active comparator | Drug: 10%povidone iodineapply 10% povidone iodine on the skin before venipuncture |
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit. Patients who needed percutaneous blood cultures were eligible for enrollment.
Key exclusion criteria (3 listed)
- Preterm infant
- Patient who had skin infection at site of venepuncture
- Patient who had history allergy to 2% Chlorhexidine gluconate in 70% alcohol or 10% povidone-iodine
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 |
|---|---|---|
| 2% chlorhexidine gluconate in 70% alcoholAlso: Chloraprepskin preparation before venipuncture for blood culture in even month | Drug | 2% Chlorhexidine Gluconate |
| 10%povidone iodineAlso: Betadineskin preparation before venipuncture for blood culture in odd month | Drug | 10% povidone iodine |
Primary outcome
efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
Time frame: 5 days
Pediatric patients who needed percutaneous blood cultures were recruited and were assigned 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months as an antiseptic for blood cultures. Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data.
1 secondary outcome
safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
Time frame: 48 hours
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 13 Aug 2013.
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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.
Auchara Tangsathapornponng, MD principal investigator
Faculty of Medicine, Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2% chlorhexidine gluconate in 70% alcohol and 10%povidone iodine in people with Bacteremia, run by Thammasat University at 1 site in Thailand.
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 3 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 13 Aug 2013. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine (time frame: 5 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 13 Aug 2013.