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Chlorhexidine for Infection Prevention

Phase 4
Recruiting
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cleared by physician to participate in a hospital-based animal-assisted visitation program session with any enrolled dog
Children between the ages of 3 and 17 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to intervention completion, an average of 60 minutes
Awards & highlights

Study Summary

This trial is testing whether a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions.

Who is the study for?
This trial is for children aged 3-17 cleared by a doctor to join hospital-based animal-assisted visitation sessions. It's not for kids who are allergic to dogs or sensitive to chlorhexidine, which is used in the study.Check my eligibility
What is being tested?
The study tests if using chlorhexidine on dogs can prevent them from transmitting pathogens like MRSA and Pseudomonas during therapy visits with hospitalized children. The trial will also see if this affects the program's benefits like reducing pain and anxiety.See study design
What are the potential side effects?
Since chlorhexidine is applied to the dogs, direct side effects on children are unlikely but may include possible skin sensitivity or allergic reactions in those exposed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctor has approved me to join a hospital program that includes visits from dogs.
Select...
My child is between 3 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to intervention completion, an average of 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to intervention completion, an average of 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child MRSA exposure
Secondary outcome measures
Child Pseudomonas aeruginosa exposure
Child and Dog Clostridium difficile prevalence
Other outcome measures
Dog MRSA fur contamination difference

Side effects data

From 2020 Phase 2 trial • 44 Patients • NCT02252588
8%
Other oral side effects
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chlorhexidine
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: CHX Intervention BExperimental Treatment1 Intervention
Dog-handler teams will follow a modified protocol for infection control, with Treatment B first for four sessions, and cross-over to Treatment A for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact. Treatment B will consist of the same pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine), with a single wipe with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival. This treatment will depend on the residual activity of chlorhexidine throughout the visit.
Group II: CHX Intervention AExperimental Treatment1 Intervention
Dog-handler teams will follow a modified protocol for infection control, with Treatment A first for four sessions, and cross-over to Treatment B for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact. Treatment A consists of a pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine) within 24 hours prior to the session, and wiping with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival at the session and every 20 minutes during the session, or between participants if the flow of participants is structured in a way that allows this (such as visits from one room to the next to visit individual patients).
Group III: ControlActive Control1 Intervention
Dog-handler teams will follow established hospital and therapy dog program guidelines for infection control with no changes for eight sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorhexidine
FDA approved

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,518 Total Patients Enrolled
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,879,676 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,580,891 Total Patients Enrolled

Media Library

Chlorhexidine Clinical Trial Eligibility Overview. Trial Name: NCT04171817 — Phase 4
MRSA Research Study Groups: CHX Intervention A, Control, CHX Intervention B
MRSA Clinical Trial 2023: Chlorhexidine Highlights & Side Effects. Trial Name: NCT04171817 — Phase 4
Chlorhexidine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04171817 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to partake in this experiment?

"To be eligible for this research trial, individuals need to have been diagnosed with clostridium difficile and should range in age from 3 to 17 years old. There are currently 412 spots available within the study."

Answered by AI

Does this clinical experiment accept participants who are over two decades old?

"This clinical trial is recruiting participants aged 3 to 17 years old."

Answered by AI

Have any prior experiments been conducted utilizing Chlorhexidine?

"Chlorhexidine's initial clinical trials began at Sanford USD Medical Center in 2014. Since then, 227 studies have concluded and 22 further projects are ongoing, primarily based around Philadelphia."

Answered by AI

Are enrollees currently being accepted for this clinical experiment?

"Unfortunately, this research is not taking on any new participants at the moment. The study was initially published and last updated in November and October of 2022 respectively. If you wish to find other studies, there are 13 that involve Clostridium difficile while 22 trials require subjects with Chlorhexidine exposure history."

Answered by AI

How many individuals have been recruited to participate in this clinical experiment?

"At present, there is no recruitment for this trial. It was initially posted on November 1st 2022 and had its final update October 14th 20212. To find alternative studies, 13 trials are open to patients with clostridium difficile and 22 clinical experiments allow participation from those affected by chlorhexidine."

Answered by AI

Has the United States Food and Drug Administration certified Chlorhexidine?

"Chlorhexidine is already approved for use, so it has earned a score of 3 on our safety scale."

Answered by AI

In what cases is Chlorhexidine commonly administered?

"Chlorhexidine is an effective means of dealing with antisepsis, disinfection, and sore throats."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Animal-Assisted Visitation Program Chlorhexidine Trial
2023. "Animal-Assisted Visitation Program Chlorhexidine Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04171817.
All > Clostridium Difficile > Mrsa
~173 spots leftby Dec 2024
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