Chlorhexidine AllergyPhase 1NCT02326467
Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
A Phase 1 study testing Chlorhexidine gluconate in people with Chlorhexidine Allergy and Infection, run by Celeste Chandonnet at 1 site in United States.
Trial summary
Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated infections (HAIs). Read more about this study
- Who is it for?
- Ages 36 to 48 weeks
- Conditions the study is for
- Chlorhexidine Allergy, Infection, Rash
- What is being tested?
- Chlorhexidine gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 1 Jul 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 36 to 48 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Greater than/equal to 36 weeks PMA (gestational age + chronological age)
- Less than/equal to 48 weeks PMA (gestational age + chronological age)
- Greater than/equal to 3 days of age
- Existing or soon to be placed, peripheral or surgical CVC
- Permission to participate in trial by attending physician
- Parent or legal guardian informed consent to participate in the trial
Who cannot join
- • Infant with a large open lesion or severe skin condition (i.e., Myelomeningocele, Gastroschisis, lymphatic malformation, open chest, ostomies and/or mucus fistulas or Icthyosis)
- Infants with active seizure disorders
- Infants with Hypoxic Ischemic Encephalopathy
- Infants with severe multi-system organ failure or Liver failure as defined by documentation of abnormal liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) Gamma-glutamyltransferase (GGT) and L-lactate dehydrogenase (LD).
- Infant with renal impairment as defined by: documented serum Creatinine greater than 0.7, renal disorders (renal agenesis, polycystic kidney disease, dysplastic kidneys, acute renal injury).
- Infants deemed clinically unstable by their physician such as patients that are extremely fragile and wouldn't tolerate the stimulation of the bathing process or those infants being considered for withdrawal of care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated infections (HAIs). CHG is believed to be superior to other forms of antiseptics because, when it is applied to the skin surface, it leaves a lasting residue on the skin. CHG has been shown to be well tolerated in patients 2 months of age and older. However there is limited evidence to support the use of topically applied CHG in infants less than 2 months of age because of potential safety concerns in this population. The purpose of this study will be to describe the safety of bi-weekly CHG baths in a sample of Newborn Intensive Care Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients by measuring the incidence of skin problems and CHG blood levels.
Read the detailed description
Evidence overwhelmingly supports the use of Chlorhexidine Gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing Healthcare-associated Infections (HAIs). CHG provides prolonged protection against both gram-positive and gram-negative organisms. Reports indicate CHG is well tolerated in patients greater than two months of age. However, due to safety concerns, there is limited evidence to support the use of topically applied CHG in infants less than 2 months of age.
The purpose of this Phase I Clinical (pilot) study is to describe the safety of bi-weekly CHG baths in a sample of 50 Newborn Intensive Care Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients, (36 weeks PMA or older, less than 2 months of age or 48 weeks PMA and with a CVC), by measuring the incidence of skin problems and CHG blood levels. CHG baths will be performed every Monday and Thursday during the day shift, for up to 12 weeks post enrollment or until the CVC is removed or the patient is discharged.
Chlorhexidine Gluconate bathing cloths are marketed for peri-operative skin preparation. However, daily CHG baths are a common practice in ICUs around the nation because of its proven method for preventing HAIs in patients > 2 months of age and older. Furthermore, CHG use for skin antisepsis has become a widely accepted practice, and it is now part of the Centers for Disease Control and Prevention (CDC) CVC maintenance bundle for use in patients greater than 2 months of age, and a recommendation to use with caution in infants < 2 months of age.
Hypothesis 1:CHG will be safe for use in a sample of infants 36 weeks PMA or older, and less than 2 months of age (48 weeks PMA) with a CVC as evidenced by an adverse event rate less than 10%.
Hypothesis 2: Twice weekly CHG baths do not lead to rising (cumulative) CHG blood levels, LFTs (AST/ALT) and Serum Creatinine over time in a sample of infants 36 weeks PMA or older, and less than 2 months of age (48 weeks PMA) with a CVC..
- Conditions
- Chlorhexidine Allergy, Infection, Rash
- Being tested
- Chlorhexidine gluconate
- Keywords
- chlorhexidine, safety, bath, rash, infant
- Medical subject headings
- Infections, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Sage® 2% Chlorhexidine Gluconate Cloth
Bi-weekly chlorhexidine baths
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine gluconate bath | Experimental | All subjects will receive a bath twice a week with 2% CHG bathing cloths. The baths will be followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team will monitor the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels will be monitored for associated adverse events and accumulation. Receives: Drug: Chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Study Participants With Skin Reactions Less Than 10%
- Study RN's will perform a full body skin assessment for skin irritation or open areas prior to each bath.
- Bedside RN's will complete skin assessments every 12 hours during the course of the study.
- Descriptive statistics including mean, median, range and frequencies will be used to describe adverse events (including skin reactions and other untoward events). We will characterize the demographic and clinical characteristics of subjects that experience adverse events, although we will not perform hypothesis tests of association. We will consider time-to-rash data using Kaplan-Meier estimators.
Measured: Adverse Events assessed every 12 hours for the duration of study participation (max 90 days)
Secondary outcomes (1)
The Number of Participants With Detectable CHG Blood Levels
To monitor for absorption into the blood, a single CHG level will be obtained at baseline and then weekly on Fridays for the remainder of the study for each study participant. A CHG level will also be drawn when an infant is removed from the study in response to an adverse reaction. Of note, a threshold for safe, normal or toxic CHG level is not known, thus we will closely monitor blood levels and convene a meeting of the Data Safety and Monitoring Committee (DSMC) if adverse reactions develop in association with elevated blood levels.
Measured: CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startFeb 2016
- Primary completion13 Sep 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chlorhexidine AllergyStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celeste Chandonnet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Celeste Chandonnet, Boston Children's Hospital
- Investigators
- Celeste J Chandonnet, BSN CCRN CIC, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326467
- Sponsor's protocol ID
- IRB-P00011128
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2014
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
- ClinicalTrials.gov ID
- NCT02326467
- Acronym / sponsor ID
- IRB-P00011128
- Conditions
- Chlorhexidine Allergy, Infection, Rash
- Keywords
- chlorhexidine, safety, bath, rash, infant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Celeste ChandonnetUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Posted 27 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated infections (HAIs). CHG is believed to be superior to other forms of antiseptics because, when it is applied to the skin surface, it leaves a lasting residue on the skin. CHG has been shown to be well tolerated in patients 2 months of age and older. However there is limited evidence to support the use of topically applied CHG in infants less than 2 months of age because of potential safety concerns in this population. The purpose of this study will be to describe the safety of bi-weekly CHG baths in a sample of Newborn Intensive Care Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients by measuring the incidence of skin problems and CHG blood levels.
Detailed description
Evidence overwhelmingly supports the use of Chlorhexidine Gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing Healthcare-associated Infections (HAIs). CHG provides prolonged protection against both gram-positive and gram-negative organisms. Reports indicate CHG is well tolerated in patients greater than two months of age. However, due to safety concerns, there is limited evidence to support the use of topically applied CHG in infants less than 2 months of age.
The purpose of this Phase I Clinical (pilot) study is to describe the safety of bi-weekly CHG baths in a sample of 50 Newborn Intensive Care Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients, (36 weeks PMA or older, less than 2 months of age or 48 weeks PMA and with a CVC), by measuring the incidence of skin problems and CHG blood levels. CHG baths will be performed every Monday and Thursday during the day shift, for up to 12 weeks post enrollment or until the CVC is removed or the patient is discharged.
Chlorhexidine Gluconate bathing cloths are marketed for peri-operative skin preparation. However, daily CHG baths are a common practice in ICUs around the nation because of its proven method for preventing HAIs in patients > 2 months of age and older. Furthermore, CHG use for skin antisepsis has become a widely accepted practice, and it is now part of the Centers for Disease Control and Prevention (CDC) CVC maintenance bundle for use in patients greater than 2 months of age, and a recommendation to use with caution in infants < 2 months of age.
Hypothesis 1:CHG will be safe for use in a sample of infants 36 weeks PMA or older, and less than 2 months of age (48 weeks PMA) with a CVC as evidenced by an adverse event rate less than 10%.
Hypothesis 2: Twice weekly CHG baths do not lead to rising (cumulative) CHG blood levels, LFTs (AST/ALT) and Serum Creatinine over time in a sample of infants 36 weeks PMA or older, and less than 2 months of age (48 weeks PMA) with a CVC..
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate bath | Experimental | Drug: Chlorhexidine gluconateAll subjects will receive a bath twice a week with 2% CHG bathing cloths. The baths will be followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team will monitor the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels will be monitored for associated adverse events and accumulation. |
Who may qualify
- Ages
- 36 to 48 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Greater than/equal to 36 weeks PMA (gestational age + chronological age)
- Less than/equal to 48 weeks PMA (gestational age + chronological age)
- Greater than/equal to 3 days of age
- Existing or soon to be placed, peripheral or surgical CVC
- Permission to participate in trial by attending physician
Key exclusion criteria (6 listed)
- • Infant with a large open lesion or severe skin condition (i.e., Myelomeningocele, Gastroschisis, lymphatic malformation, open chest, ostomies and/or mucus fistulas or Icthyosis)
- Infants with active seizure disorders
- Infants with Hypoxic Ischemic Encephalopathy
- Infants with severe multi-system organ failure or Liver failure as defined by documentation of abnormal liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) Gamma-glutamyltransferase (GGT) and L-lactate dehydrogenase (LD).
- Infant with renal impairment as defined by: documented serum Creatinine greater than 0.7, renal disorders (renal agenesis, polycystic kidney disease, dysplastic kidneys, acute renal injury).
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 |
|---|---|---|
| Chlorhexidine gluconateAlso: Sage® 2% Chlorhexidine Gluconate ClothBi-weekly chlorhexidine baths | Drug | Chlorhexidine gluconate bath |
Primary outcome
Percentage of Study Participants With Skin Reactions Less Than 10%
Time frame: Adverse Events assessed every 12 hours for the duration of study participation (max 90 days)
1. Study RN's will perform a full body skin assessment for skin irritation or open areas prior to each bath. 2. Bedside RN's will complete skin assessments every 12 hours during the course of the study. 3. Descriptive statistics including mean, median, range and frequencies will be used to describe adverse events (including skin reactions and other untoward events). We will characterize the demographic and clinical characteristics of subjects that experience adverse events, although we will not perform hypothesis tests of association. We will consider time-to-rash data using Kaplan-Meier estimators.
1 secondary outcome
The Number of Participants With Detectable CHG Blood Levels
Time frame: CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Celeste J Chandonnet, BSN CCRN CIC principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chlorhexidine gluconate in people with Chlorhexidine Allergy and Infection, run by Celeste Chandonnet at 1 site in United States.
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 6 inclusion and 6 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 27 Jul 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Study Participants With Skin Reactions Less Than 10% (time frame: Adverse Events assessed every 12 hours for the duration of study participation (max 90 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 27 Jul 2021.