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Mupirocin to Reduce Staphylococcus Aureus Colonization in Infants Hospitalized in a NICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02967432
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
Jana Shaw, MD
Steven Gross, MD
David Martin, RN
Dale Franz, RPh
Rachel Carey
Information provided by (Responsible Party):
Melissa Nelson, Crouse Hospital

Brief Summary:
The purpose of this study is to determine whether or not mupirocin treatment results in S. aureus decolonization in affected NICU patients.

Condition or disease Intervention/treatment Phase
Staphylococcus Drug: Mupirocin Topical Ointment Drug: Petroleum Jelly Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Mupirocin to Reduce Staphylococcus Aureus Colonization in Infants Hospitalized in a Neonatal Intensive Care Unit
Study Start Date : October 2016
Estimated Primary Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mupirocin Drug: Mupirocin Topical Ointment
Mupirocin ointment 1/2 inch ribbon applied topically to each nare and umbilicus twice daily for 5 days; repeat treatment courses possible.

Placebo Comparator: Petroleum jelly Drug: Petroleum Jelly
Petroleum jelly ointment 1/2 inch ribbon applied topically to each nare and umbilicus twice daily for 5 days; repeat treatment courses possible.




Primary Outcome Measures :
  1. Decolonization efficacy [ Time Frame: Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days ]
    Compare the number of S. aureus patient colonization days between treatment versus control group


Secondary Outcome Measures :
  1. Trajectory of decolonization efficacy [ Time Frame: Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days ]
    Compare the proportions of persistently colonized, decolonized, and recolonized study subjects at each subsequent weekly screening interval in treatment versus control group

  2. Incidence of recolonization [ Time Frame: Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days ]
    Determine the incidence and timing of recolonization with S. aureus following decolonization within the treatment group

  3. Incidence of S. aureus infection [ Time Frame: Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days ]
    Determine and compare the incidence of nosocomial invasive S. aureus infection in treatment versus control group

  4. Incidence of mupirocin-resistance [ Time Frame: Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days ]
    Determine the incidence of mupirocin-resistance in S. aureus isolates from treatment versus control group

  5. Long-term decolonization efficacy [ Time Frame: Within 2 months of discharge from NICU ]
    Determine and compare the incidence of S. aureus colonization between 1-2 months after discharge between treatment versus control group



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants admitted to Crouse Hospital NICU with MSSA/MRSA colonization that have parental consent for participation obtained within 2 days of their initial positive screen.

Exclusion Criteria:

  • Any infant with an active or previous S. aureus infection at time of initial positive S. aureus colonization screen.
  • Any infant with a condition thought to be fatal/irreversible (pulmonary hypoplasia, chromosomal/genetic syndromes, fatal cardiac anomalies).
  • Any infant with a congenital condition that would prevent specimen collection or treatment application (cleft lip/palate, choanal atresia, abdominal wall defects, imperforate anus, etc.).
  • Sufficient length of NICU admission will be necessary to adequately measure the primary outcome. Therefore, enrolled patients will only be included in data analysis if they remain in the NICU until after at least one subsequent MSSA/MRSA screening is performed following completion of their initial treatment course with either mupirocin or placebo.

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): NCT02967432


Contacts
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Contact: Melissa U Nelson, MD 3154707379 melissanelsonmd@crouse.org
Contact: Steven J Gross, MD 3154707379 stevengrossmd@crouse.org

Locations
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United States, New York
Crouse Hospital - Neonatal Intensive Care Unit Recruiting
Syracuse, New York, United States, 13210
Contact: Melissa U Nelson, MD    315-470-7379    melissanelsonmd@crouse.org   
Contact: Steven J Gross, MD    3154707379    stevengrossmd@crouse.org   
Principal Investigator: Melissa Nelson U Nelson, MD         
Principal Investigator: Jana Shaw, MD         
Sub-Investigator: Steven J Gross, MD         
Sponsors and Collaborators
Crouse Hospital
Jana Shaw, MD
Steven Gross, MD
David Martin, RN
Dale Franz, RPh
Rachel Carey
Investigators
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Principal Investigator: Melissa U Nelson, MD Crouse Hospital
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Responsible Party: Melissa Nelson, MD, Attending Physician, Neonatologist, Crouse Hospital
ClinicalTrials.gov Identifier: NCT02967432    
Other Study ID Numbers: Crouse Hospital 2016.0125
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Melissa Nelson, Crouse Hospital:
Staphylococcus aureus
Staphylococcal colonization
Staphylococcal infection
Mupirocin
Mupirocin-resistance
Additional relevant MeSH terms:
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Mupirocin
Petrolatum
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents