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Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial (TREAT PARENTS)

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ClinicalTrials.gov Identifier: NCT02223520
Recruitment Status : Recruiting
First Posted : August 22, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This trial will test the hypothesis that treating parents of neonates requiring NICU care with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S. aureus from parents to their neonates.

Condition or disease Intervention/treatment Phase
Staph Aureus Colonization Staph Aureus Infection Drug: Mupirocin and Chlorhexidine Drug: Placebo ointment and placebo cloths Not Applicable

Detailed Description:

The TREAT PARENTS Trial, or Treating Parents to Reduce NICU Transmission of S. aureus, is a placebo-controlled, double-masked, randomized clinical trial to test the hypothesis that treatment of S. aureus colonized parents with intranasal mupirocin and topical chlorhexidine gluconate antisepsis will decrease neonatal S. aureus acquisition. All neonates admitted to the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center NICUs will be pre-screened and parents will be approached for enrollment in the study. After consent and baseline screening, 400 neonate-parent pairs will be randomized; only neonates who have a parent colonized with S. aureus will be randomized. Parents will receive a 5 day treatment with intranasal mupirocin plus topical chlorhexidine gluconate antisepsis or placebo.

After recruitment and informed consent, parents will undergo pre-randomization screening. If both parents screen negative for S. aureus colonization, the neonate will be ineligible for the randomization and parents will be informed that they are not colonized at that time with S. aureus. If either parent screens positive for S. aureus, then both parents as a pair will be eligible for randomization to one of the two possible masked treatment arms. The neonate-parent "pair" will be the unit of randomization and each parent will be allocated to the same group if both consent.

After the baseline neonate testing for S. aureus colonization, repeat testing will be performed every 7 days for the neonates until the neonate acquires S. aureus colonization or is discharged from the NICU.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Treating Parents to Reduce Neonatal Intensive Care Unit (NICU) Transmission of Staphylococcus Aureus
Study Start Date : November 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Active Comparator: Mupirocin and Chlorhexidine
Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.
Drug: Mupirocin and Chlorhexidine
Other Names:
  • bactroban
  • chlorhexidine gluconate
Placebo Comparator: Placebo ointment and placebo cloths
Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.
Drug: Placebo ointment and placebo cloths



Primary Outcome Measures :
  1. Neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain [ Time Frame: 90 days ]
    Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups. Planned secondary analysis will include a comparison of the proportion of neonates acquiring concordant S. aureus by 4 and 8 weeks into their NICU stay across the two groups.


Secondary Outcome Measures :
  1. Neonatal acquisition of S. aureus [ Time Frame: 90 days ]
    Neonatal acquisition of S. aureus will be determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of colonization comparing Treatment and Control Groups.

  2. Neonatal S. aureus infection [ Time Frame: 90 days ]
  3. Eradication of S. aureus colonization in parents following treatment [ Time Frame: 28 days, 56 days ]
  4. Natural history of S. aureus colonization in parents receiving placebo [ Time Frame: 28 days, 56 days ]
  5. Adverse reactions to treatment [ Time Frame: During the 5 day treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Neonate has never had a clinical or surveillance culture grow S. aureus
  • Neonate was transferred from another hospital or admitted from home and had admission screening cultures for S. aureus colonization that were negative (if admission cultures were not performed, they will be performed as part of the pre-randomization screening process)
  • Parent(s) is(are) able to visit the child at the bedside
  • Parent(s) test positive for S. aureus at screening
  • Neonate has anticipated stay longer than 5 days in the NICU (if estimated stay is unclear, parents can be screened for S. aureus colonization and decision to randomize can be delayed until hospital day 3 or 4 after reassessment of anticipated stay).
  • Parents is(are) willing to be randomized
  • No documented or reported allergies to any agent used in either treatment regimen
  • Able to perform written informed consent

Exclusion Criteria:

  • Allergies to any agent used in either treatment regimen
  • Neonate has had a prior clinical or surveillance culture grow S. aureus
  • Neonate admitted to NICU from home and is greater than 7 days of age
  • Neonate admitted to NICU from another hospital and is greater than 7 days of age
  • Neonate is a ward of the State
  • Not able to provide written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223520


Contacts
Contact: Aaron Milstone, MD, MHS 443-287-8932 amilsto1@jhmi.edu
Contact: Annie Voskertchian, MPH 443-287-9040 avosker1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Annie Voskertchian, MPH    443-287-9040    avosker1@jhmi.edu   
Sub-Investigator: Maureen Gilmore, MD         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Annie Voskertchian, MPH    443-287-9040    avosker1@jhmi.edu   
Principal Investigator: Aaron Milstone, MD, MHS         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Aaron Milstone, MD, MHS Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02223520     History of Changes
Other Study ID Numbers: NA_00092982
R01HS022872 ( U.S. AHRQ Grant/Contract )
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Johns Hopkins University:
Staphylococcus aureus
Infection
Colonization
Transmission
Neonate

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action