Animal-Assisted Visitation Program Chlorhexidine Trial

NCT04171817 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: R01HD097692IRB00205311
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

Hospital-based Animal-Assisted visitation programs are important complementary therapies, but concerns with infection control may challenge the sustainability of these programs. Pilot data suggest that a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions. In this study, the following aims will be tested: 1) To identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention (AAI) sessions during an initial run-in phase of no intervention; 2) To determine the effect of chlorhexidine (CHX)-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during AAI sessions via a multicenter randomized controlled trial; and 3) To determine whether the specific benefits achieved by the visitation program, i.e. reduction in blood pressure, heart rate and self-reported pain and anxiety, are impacted by the interventions.

Conditions

Pseudomonas Aeruginosa; Methicillin-resistant Staphylococcus Aureus; Clostridium Difficile

Keywords

therapy dog; canine; animal assisted intervention; chlorhexidine; child

Outcome Measures

Primary Outcomes (1)

• Child MRSA exposure

  MRSA exposure is defined as children who do not have detectable methicillin-resistant Staphylococcus aureus (MRSA) nasal carriage before the dog session who then have MRSA detection (MRSA nasal carriage) after the dog session.

  Baseline through intervention completion, an average of 60 minutes

Secondary Outcomes (2)

• Child Pseudomonas aeruginosa exposure

  Baseline through intervention completion, an average of 60 minutes

• Child and Dog Clostridium difficile prevalence

  Baseline to intervention completion, an average of 60 minutes

Other Outcomes (1)

• Dog MRSA fur contamination difference

  Baseline through intervention completion, an average of 60 minutes

Study Arms (3)

Control

NO 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.

CHX Intervention A

EXPERIMENTAL

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).

Drug: Chlorhexidine

CHX Intervention B

EXPERIMENTAL

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.

Drug: Chlorhexidine

Interventions

Chlorhexidine DRUG

The goal of this work is to assess the effect of chlorhexidine (CHX)-based interventions--specifically use of pre-session chlorhexidine shampoo for the dog and use of chlorhexidine wipes on the dog's fur--on patient exposure to hospital-associated pathogens during the sessions with the dogs

Also known as: CHX

CHX Intervention A; CHX Intervention B

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 3 and 17 years
• Cleared by physician to participate in a hospital-based animal-assisted visitation program session with any enrolled dog

You may not qualify if:

• Children who report sensitivity to chlorhexidine products
• Children who report allergy to dogs or sensitivity to dog allergen

Sponsors & Collaborators

• University of Pennsylvania: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Johns Hopkins Bloomberg School of Public Health: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (3)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pseudomonas Infections

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Meghan F Davis, DVM, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, parallel-arm randomized controlled trial, with 1:1 allocation for intervention versus control. Among those randomized to intervention, dog-handler teams will be additionally randomized to Intervention A first, with crossover to Intervention B, or to Intervention B first, with crossover to Intervention A.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: May 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available at the time of first publication of the sequencing results.
• Access Criteria: There are no specific access criteria instituted by the study. Access will be controlled by NCBI.

Locations

US (3)