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Chlorhexidine for Infection Prevention

Phase 4

Recruiting

Led By Meghan F Davis, DVM, PhD

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

Children between the ages of 3 and 17 years

Be younger than 18 years old

Must not have

Children who report sensitivity to chlorhexidine products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to intervention completion, an average of 60 minutes

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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 child is between 3 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to chlorhexidine products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to intervention completion, an average of 60 minutes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child MRSA exposure

Secondary study objectives

Child Pseudomonas aeruginosa exposure

Child and Dog Clostridium difficile prevalence

Other study objectives

Dog MRSA fur contamination difference

Side effects data

From 2020 Phase 2 trial • 44 Patients • NCT02252588

Other oral side effects

100%

80%

60%

40%

20%

Study treatment Arm

Chlorhexidine

Placebo

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 2Eligibility criteria met