NCT02967432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

3.2 years

First QC Date

November 15, 2016

Last Update Submit

December 18, 2020

Conditions

Staphylococcus

Keywords

Staphylococcus aureusStaphylococcal colonizationStaphylococcal infectionMupirocinMupirocin-resistance

Outcome Measures

Primary Outcomes (1)

  • Decolonization efficacy

    Compare the number of S. aureus patient colonization days between treatment versus control group

    Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days

Secondary Outcomes (5)

  • Trajectory of decolonization efficacy

    Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days

  • Incidence of recolonization

    Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days

  • Incidence of S. aureus infection

    Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days

  • Incidence of mupirocin-resistance

    Remaining length of NICU admission status post positive screening culture, approximately between 7 to 365 days

  • Long-term decolonization efficacy

    Within 2 months of discharge from NICU

Study Arms (2)

Mupirocin

EXPERIMENTAL
Drug: Mupirocin Topical Ointment

Petroleum jelly

PLACEBO COMPARATOR
Drug: Petroleum Jelly

Interventions

Mupirocin Topical OintmentDRUG

Mupirocin ointment 1/2 inch ribbon applied topically to each nare and umbilicus twice daily for 5 days; repeat treatment courses possible.

Mupirocin
Petroleum JellyDRUG

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

Petroleum jelly

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crouse Hospital - Neonatal Intensive Care Unit

Syracuse, New York, 13210, United States

Location

Related Publications (1)

  • Nelson MU, Shaw J, Gross SJ. Randomized Placebo-Controlled Trial of Topical Mupirocin to Reduce Staphylococcus aureus Colonization in Infants in the Neonatal Intensive Care Unit. J Pediatr. 2021 Sep;236:70-77. doi: 10.1016/j.jpeds.2021.05.042. Epub 2021 May 21.

    PMID: 34023342DERIVED

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

HydrocarbonsOrganic Chemicals

Study Officials

  • Melissa U Nelson, MD

    Crouse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Attending Physician, Neonatologist

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 18, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)