Nosocomial InfectionsPhase 2/3NCT00549393
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
A Phase 2/3 study testing 2% Chlorhexidine gluconate cloth in people with Nosocomial Infections, run by Johns Hopkins University at 5 sites in United States.
Trial summary
The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU). Read more about this study
- Who is it for?
- Ages 2 months to 25 years
- Conditions the study is for
- Nosocomial Infections
- What is being tested?
- 2% Chlorhexidine gluconate cloth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,659 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2008to Jun 2012
- Phase
- Phase 2/3
- 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 2 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients in pediatric intensive care unit
Who cannot join
- Patients with a history of an allergic reaction to chlorhexidine
- Patients less than 2 months of age
- Patients with severe skin disease or burn
- Patients with an indwelling epidural catheter or lumbar drain
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105
Saint Louis Children's Hospital
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).
- Conditions
- Nosocomial Infections
- Being tested
- 2% Chlorhexidine gluconate cloth
- Keywords
- intensive care unit, Healthcare associated infections (HAI), pediatric
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Chlorhexidine gluconate clothDrug
Daily bathing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Daily bathing with 2% chlorhexidine gluconate Receives: Drug: 2% Chlorhexidine gluconate cloth |
| 2 | No intervention | Standard bathing with soap and water basin or disposable cloth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteremia
incidence of bacteremia comparing those in treatment and control groups
Measured: participants were followed for the duration of ICU stay, median stay 3 days
Secondary outcomes (1)
Central Line Associated-bloodstream Infection (CLABSI)
Comparing incidence of central line-associated bloodstream infections between treatment and control groups
Measured: participants were followed for the duration of ICU stay, median stay 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionJun 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nosocomial InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5,659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Sage Products, Inc.
- Responsible party
- Sponsor
- Investigators
- Trish M Perl, MD MSc, Principal investigator, Johns Hopkins UniversityAaron Milstone, MD MHS, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549393
- Sponsor's protocol ID
- NA_00006799
- Status last verified
- May 2017
- First submitted
- 24 Oct 2007
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.
PubMed 23363666
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00549393
- Acronym / sponsor ID
- NA_00006799
- Conditions
- Nosocomial Infections
- Keywords
- intensive care unit, Healthcare associated infections (HAI), pediatric
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,659 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Sage Products, Inc.
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Posted 2 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 2% Chlorhexidine gluconate clothDaily bathing with 2% chlorhexidine gluconate |
| 2 | No intervention | –Standard bathing with soap and water basin or disposable cloth |
Who may qualify
- Ages
- 2 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients in pediatric intensive care unit
Key exclusion criteria (4 listed)
- Patients with a history of an allergic reaction to chlorhexidine
- Patients less than 2 months of age
- Patients with severe skin disease or burn
- Patients with an indwelling epidural catheter or lumbar drain
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 clothDaily bathing | Drug | 1 |
Primary outcome
Bacteremia
Time frame: participants were followed for the duration of ICU stay, median stay 3 days
incidence of bacteremia comparing those in treatment and control groups
1 secondary outcome
Central Line Associated-bloodstream Infection (CLABSI)
Time frame: participants were followed for the duration of ICU stay, median stay 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23363666Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.
Related trials for Nosocomial Infections
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
RecruitingObservational study
IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients
Critical Illness, Intensive Care Patients
Recruiting
Nosocomial Respiratory Virus Infection
Nosocomial Infections
RecruitingObservational study
Natural History of Clostridioides Difficile Infection
Clostridium Difficile Infection, Health Care Associated Infection
Not yet recruiting
Resistance-Optimised Antimicrobial Dosing in Critically Ill Patients, a Randomised Controlled Trial
Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
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.
Trish M Perl, MD MSc principal investigator
Johns Hopkins University
Aaron Milstone, MD MHS study chair
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2% Chlorhexidine gluconate cloth in people with Nosocomial Infections, run by Johns Hopkins University at 5 sites 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 1 inclusion and 4 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Oct 2015). 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?
Bacteremia (time frame: participants were followed for the duration of ICU stay, median stay 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00549393, which also lists 1 linked publication.
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 14 Jun 2017.