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Trial record 21 of 47 for:    necrotizing enterocolitis | NIH

Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants

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ClinicalTrials.gov Identifier: NCT01827358
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Primary Purpose: Prevention
Condition: Staphylococcal Infection
Intervention: Drug: Mupirocin calcium

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Infants less than 24 months of age were recruited from among those admitted to the NICU or ICU at one of the participating centers found to have a surveillance nasal swab culture positive for SA. Recruitment was performed sequentially as infants became eligible without regards for race, ethnicity, gestational age or gender.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Infants were screened for nasal SA colonization (MRSA or MSSA) and only those who were colonized (not infected) were offered enrollment.

Reporting Groups
  Description
Mupirocin (Treatment) Participants received 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
No Mupirocin (Control) Participants received no treatment or placebo

Participant Flow:   Overall Study
    Mupirocin (Treatment)   No Mupirocin (Control)
STARTED   80   75 
COMPLETED   45   44 
NOT COMPLETED   35   31 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mupirocin (Treatment) Participants received 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
No Mupirocin (Control) Participants received no treatment or placebo
Total Total of all reporting groups

Baseline Measures
   Mupirocin (Treatment)   No Mupirocin (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   75   155 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      80 100.0%      75 100.0%      155 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 4.6  (3.6)   4.8  (4.4)   4.7  (4.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      35  43.8%      33  44.0%      68  43.9% 
Male      45  56.3%      42  56.0%      87  56.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   2.5%      4   5.3%      6   3.9% 
Not Hispanic or Latino      76  95.0%      66  88.0%      142  91.6% 
Unknown or Not Reported      2   2.5%      5   6.7%      7   4.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.3%      1   1.3%      2   1.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      22  27.5%      25  33.3%      47  30.3% 
White      50  62.5%      41  54.7%      91  58.7% 
More than one race      6   7.5%      7   9.3%      13   8.4% 
Unknown or Not Reported      1   1.3%      1   1.3%      2   1.3% 
Region of Enrollment 
[Units: Participants]
     
United States   80   75   155 


  Outcome Measures

1.  Primary:   Number of Participants With Solicited Adverse Events (AEs) During Days 1-7   [ Time Frame: Days 1 through 7 ]

2.  Primary:   Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7   [ Time Frame: Days 1 through 7 ]

3.  Primary:   Number of Participants With Serious Adverse Events (SAEs) During Days 1-7   [ Time Frame: Days 1 through 7 ]

4.  Primary:   Primary Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures Obtained on Day 8.   [ Time Frame: Day 8 ]

5.  Primary:   Persistent Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures on Days 8 and 22.   [ Time Frame: Day 8 and Day 22 ]

6.  Secondary:   Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort   [ Time Frame: Day 1 through 85 ]

7.  Secondary:   Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.   [ Time Frame: Day 1 through 85 ]

8.  Secondary:   Median Time to Occurrence of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group.   [ Time Frame: Day 1 through 85 ]

9.  Secondary:   Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.   [ Time Frame: Day 1 through 22 ]

10.  Secondary:   Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.   [ Time Frame: Day 1 through 22 ]

11.  Secondary:   Median Time to Occurrence of Non-S. Aureus (SA) Clinical Infection in the Treatment Compared to Control Group   [ Time Frame: Day 1 through 85 ]

12.  Secondary:   Relative Risk of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group   [ Time Frame: Day 1 through 85 ]

13.  Secondary:   Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).   [ Time Frame: Day 1 through 85 ]

14.  Secondary:   Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.   [ Time Frame: Day 1 through 85 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Karen Kotloff, MD
Organization: University of Maryland Medical Center
phone: 410-706-5328
e-mail: kkotloff@medicine.umaryland.edu



Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01827358     History of Changes
Other Study ID Numbers: 09-0065
First Submitted: April 4, 2013
First Posted: April 9, 2013
Results First Submitted: June 1, 2017
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017