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History of Changes for Study: NCT01827358
Safety and Efficacy of Intranasal and Topical Mupirocin in Eradicating Colonization With Staphylococcus Aureus (SA) in Critically Ill Infants - a Phase 2, Multi-Center, Open Label, Randomized Trial
Latest version (submitted June 29, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 4, 2013 None (earliest Version on record)
2 April 11, 2013 Study Status
3 April 18, 2013 Study Status
4 April 25, 2013 Outcome Measures, Study Description and Study Status
5 May 2, 2013 Study Status
6 May 10, 2013 Study Status
7 May 16, 2013 Study Status
8 May 23, 2013 Study Status
9 May 30, 2013 Study Status
10 June 6, 2013 Contacts/Locations and Study Status
11 June 13, 2013 Study Status
12 June 20, 2013 Study Status
13 June 27, 2013 Study Status
14 July 11, 2013 Study Status
15 July 18, 2013 Study Status, Eligibility, Conditions and Study Description
16 July 25, 2013 Study Status
17 August 1, 2013 Study Status
18 August 8, 2013 Study Status
19 August 15, 2013 Study Status
20 August 22, 2013 Study Status
21 August 29, 2013 Study Status
22 September 12, 2013 Study Status
23 September 19, 2013 Study Status
24 September 26, 2013 Study Status
25 October 4, 2013 Conditions and Study Status
26 October 10, 2013 Study Status
27 October 17, 2013 Study Status
28 October 24, 2013 Study Status
29 October 31, 2013 Study Status
30 November 7, 2013 Contacts/Locations and Study Status
31 November 14, 2013 Study Status
32 November 21, 2013 Contacts/Locations and Study Status
33 December 5, 2013 Study Status
34 December 12, 2013 Study Status
35 December 19, 2013 Study Status
36 January 2, 2014 Study Status
37 January 9, 2014 Study Status
38 January 23, 2014 Study Status
39 January 30, 2014 Study Status
40 February 6, 2014 Study Status
41 February 13, 2014 Conditions and Study Status
42 February 20, 2014 Study Status
43 February 27, 2014 Study Status
44 March 13, 2014 Study Status
45 March 20, 2014 Study Status
46 March 27, 2014 Study Status
47 April 3, 2014 Contacts/Locations and Study Status
48 April 10, 2014 Contacts/Locations and Study Status
49 April 17, 2014 Recruitment Status, Contacts/Locations and Study Status
50 April 24, 2014 Study Status
51 May 1, 2014 Study Status
52 May 15, 2014 Contacts/Locations and Study Status
53 May 22, 2014 Study Status
54 May 29, 2014 Study Status
55 June 5, 2014 Study Status
56 June 12, 2014 Study Status
57 June 19, 2014 Study Status
58 June 26, 2014 Study Status
59 July 3, 2014 Study Status
60 July 10, 2014 Study Status
61 July 17, 2014 Study Status
62 July 24, 2014 Study Status
63 July 31, 2014 Study Status
64 August 7, 2014 Study Status
65 August 14, 2014 Study Status
66 August 21, 2014 Study Status
67 August 28, 2014 Contacts/Locations and Study Status
68 September 4, 2014 Study Status
69 September 11, 2014 Study Status
70 September 18, 2014 Study Status
71 September 25, 2014 Study Status
72 October 2, 2014 Study Status
73 October 9, 2014 Study Status
74 October 16, 2014 Study Status
75 October 23, 2014 Study Status
76 October 30, 2014 Study Status
77 November 6, 2014 Arms and Interventions, Study Status and Study Identification
78 November 13, 2014 Study Status
79 December 4, 2014 Outcome Measures and Study Status
80 December 11, 2014 Study Status and Study Identification
81 December 18, 2014 Study Status
82 January 15, 2015 Study Status
83 January 22, 2015 Study Status
84 January 29, 2015 Study Status
85 February 5, 2015 Study Status
86 February 19, 2015 Outcome Measures, Study Status and Eligibility
87 February 26, 2015 Outcome Measures and Study Status
88 March 5, 2015 Study Status
89 March 12, 2015 Eligibility and Study Status
90 March 26, 2015 Outcome Measures and Study Status
91 April 2, 2015 Study Status
92 April 9, 2015 Study Status
93 April 16, 2015 Study Status
94 April 23, 2015 Study Status
95 April 30, 2015 Study Status
96 May 7, 2015 Study Status
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99 May 28, 2015 Study Status
100 June 4, 2015 Study Status
101 June 11, 2015 Study Status
102 June 25, 2015 Study Status
103 July 2, 2015 Study Status
104 July 9, 2015 Study Status
105 July 16, 2015 Study Status
106 July 23, 2015 Study Status
107 July 30, 2015 Study Status
108 August 6, 2015 Study Status
109 August 13, 2015 Study Status
110 August 20, 2015 Study Status
111 August 27, 2015 Study Status
112 September 3, 2015 Study Status
113 September 10, 2015 Study Status
114 September 24, 2015 Study Status
115 October 15, 2015 Outcome Measures, Study Description and Study Status
116 October 22, 2015 Study Status
117 October 29, 2015 Study Status
118 November 5, 2015 Study Status
119 November 12, 2015 Study Status
120 November 19, 2015 Study Status
121 November 25, 2015 Study Status
122 December 3, 2015 Study Status
123 December 10, 2015 Study Status
124 December 17, 2015 Study Status
125 December 23, 2015 Study Status
126 December 31, 2015 Study Status
127 January 7, 2016 Study Status
128 January 14, 2016 Study Status
129 January 21, 2016 Study Status
130 January 28, 2016 Study Status
131 February 4, 2016 Study Status
132 February 11, 2016 Study Status
133 February 18, 2016 Study Status
134 February 25, 2016 Study Status
135 March 3, 2016 Study Status
136 March 10, 2016 Study Description and Study Status
137 March 17, 2016 Study Status
138 March 31, 2016 Study Status
139 April 7, 2016 Study Status
140 April 14, 2016 Study Status
141 April 21, 2016 Study Status
142 April 28, 2016 Study Status
143 May 5, 2016 Study Status
144 May 12, 2016 Study Status
145 May 19, 2016 Study Status
146 May 26, 2016 Study Status
147 June 2, 2016 Study Status
148 June 30, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
149 October 27, 2016 Eligibility, Conditions, Study Status and Study Identification
150 February 16, 2017 Study Status, Oversight, Contacts/Locations, Study Design, Conditions and Study Identification
151 June 29, 2017 Outcome Measures, Study Status, Results, Study Description and Study Identification
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Study NCT01827358
Submitted Date:  April 4, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 09-0065
Brief Title: Safety and Efficacy of Intranasal and Topical Mupirocin in Eradicating Colonization With Staphylococcus Aureus (SA) in Critically Ill Infants - a Phase 2, Multi-Center, Open Label, Randomized Trial
Official Title: Safety and Efficacy of Intranasal and Topical Mupirocin in Eradicating Colonization With Staphylococcus Aureus (SA) in Critically Ill Infants - a Phase 2, Multi-Center, Open Label, Randomized Trial
Secondary IDs: MRSA CVD 1000
N01AI80057C
Open or close this module Study Status
Record Verification: March 2013
Overall Status: Not yet recruiting
Study Start:
Primary Completion: June 2016 [Anticipated]
Study Completion:
First Submitted: April 4, 2013
First Submitted that
Met QC Criteria:
April 4, 2013
First Posted: April 9, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 4, 2013
Last Update Posted: April 9, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: To examine the safety and effectiveness of mupirocin in eradicating colonization with SA (MRSA or MSSA) and preventing the occurrence of invasive and other clinically significant SA infections among infants in the ICU. To evaluate the safety and clinical acceptability of a 5-day course (15 applications) of topical mupirocin applied every 8 hours (+/= 2 hours) daily to the nares, umbilicus and perianal area of infants residing in the ICU. Infants less than 24 months of age will be recruited from among those admitted to the NICU or ICU at one of the participating centers. Study duration is 36 months. Enrolled infants will continue to receive medical care as they otherwise would if they were not enrolled in the trial. The study will be powered toward the primary endpoint with 126 participants. Enrollment may continue up to a maximum of 500 participants to inform the secondary and exploratory endpoints and to help design any subsequent study.
Detailed Description: This is a Phase 2, open label, multi-center, randomized trial to determine the safety and efficacy of mupirocin in eradicating colonization with Staphylococcus aureus (SA) and preventing the occurrence of invasive and other clinically significant SA infections among critically ill infants in the ICU. Infants hospitalized in an ICU at any one of the 6 participating centers with a positive nasal culture for SA will be eligible to enroll. Infants will be stratified by birth gestational age (< 28 weeks and <8 weeks of post-natal life or >/= 28 weeks / < 28 weeks and >/=8 weeks of post-natal life) and colonizing strain Methicillin-resistant Staphylococcus aureus (MRSA) or Methicillin-sensitive Staphylococcus aureus (MSSA) and then randomized 1:1 to receive a 5 day course of mupirocin applied to the nares, umbilicus and perianal (NUP) areas every 8 hours (+/= 2 hours) vs. no treatment. (Stratification by birth gestational age is performed to minimize bias that could result from a higher risk for developing infection due to prematurity or prolonged length of stay due to prematurity.) Each participant will be enrolled for up to 12 weeks (84 days) or until the time of discharge from the hospital, whichever occurs first. It is anticipated that it will take at least 2 years to enroll all participants. Study duration is 36 months. Enrolled infants will continue to receive medical care as they otherwise would if they were not enrolled in the trial. The study will be powered toward the primary endpoint with 126 participants. Enrollment may continue up to a maximum of 500 participants to inform the secondary and exploratory endpoints and to help design any subsequent study.
Open or close this module Conditions
Conditions: Staphylococcus Aureus
Keywords: Staphylococcus aureus, colonisation, prevention, mupirocin,critically ill, infants
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 126 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1
Subjects receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
Drug: Mupirocin ointment
Mupirocin calcium ointment 2% will be applied intranasally every 8 hours for 5 days, for a total of 15 applications
Drug: Mupirocin cream
Mupirocin calcium cream 2% applied topically to umbilicus and perianal area every 8 hours for 5 days, for a total of 15 applications
No Intervention: Group 2
No treatment
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety: Frequency of solicited adverse events(AEs), moderate and severe unsolicited AEs (that are not otherwise considered pre-defined trial endpoints), serious adverse events (SAEs) during days 1-7 and related SAEs until Day 85
[ Time Frame: Days 1 through 85 ]

2. Persistent decolonization efficacy: Proportion of infants in the treatment and control groups who have no detectable SA on direct cultures on days 8 and 22
[ Time Frame: Days 8 and 22 ]

3. Primary decolonization efficacy: Proportion of infants in the treatment and control groups who have no detectable S. aureus (SA) on direct cultures obtained on day 8
[ Time Frame: Day 8 ]

Secondary Outcome Measures:
1. Protective efficacy and median time to occurrence of clinical SA infection in the treatment compared to the control group during the 21 days after randomization or until discharge, whichever occurs first
[ Time Frame: During 21 days after randomization ]

Open or close this module Eligibility
Minimum Age:
Maximum Age: 24 Months
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Currently admitted to a NICU or ICU at a participating site
  • Chronological age less than 24 months
  • Evidence of colonization with SA (MRSA or MSSA) based on a positive nasal surveillance culture using chromogenic agar media, Randomization must occur within 120 hours of receipt of the nasal surveillance swab by the laboratory
  • The attending neonatologist/ intensivist anticipates that the infant will remain in the ICU for a minimum of 14 days after enrollment
  • Infant has never been discharged home since birth
  • Parent or legal guardian agrees that the infant will not participate in a research trial involving the administration of an investigational drug for 14 days following enrollment

Exclusion Criteria:

  • Receipt of an investigational drug as part of a research trial within the past 14 days
  • Previously enrolled and participated in this trial
  • Has an active or previous SA infection or previous SA colonization
  • Currently receiving topical or intranasal mupirocin
  • Has a rash in an area to which mupirocin will be directly applied
  • Has any of the following congenital abnormalities:
    • A congenital skin disorder (i.e. - epidermolysis bullosa, icthyosis)
    • An opened neural tube defect
    • Confirmed or suspected choanal atresia
    • Any of the following abdominal wall defects: wound dehiscence, gastroschisis, open abdominal wound (small abdominal wall defects such as ostomy sites or peritoneal drain sites are not exclusionary)
  • Is nasally intubated
  • Known hypersensitivity to the trial product or its constituents
  • Known or suspected immune deficiency. Infants born to HIV-seropositive mothers with the following risk factors for intrapartum transmission will not be eligible to participate:
    • Mother's most recent viral load within the past 3 months was > 1,000 copies/ml or
    • Mother's viral load is not known or has has not been measured in the past 3 months.
  • Any other condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant or would render the participant unable to comply with the protocol
Open or close this module Contacts/Locations
Central Contact Person: Karen L Kotloff
Telephone: (410) 706-5328
Email: kkotloff@medicine.umaryland.edu
Locations: United States, Georgia
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States, 30322-1014
United States, Maryland
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States, 21201-1509
United States, Missouri
Children's Mercy Hospital and Clinics - Infectious Diseases
Kansas City, Missouri, United States, 64108-4619
Saint Louis University School of Medicine - Cardinal Glennon Children's Medical Center - NICU
Saint Louis, Missouri, United States, 63104-1003
United States, Ohio
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States, 45229-3026
United States, Tennessee
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, United States, 37232-2573
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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