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Trial record 19 of 61 for:    Neomycin sulfate

Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

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ClinicalTrials.gov Identifier: NCT00997139
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : May 8, 2012
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasal Carriers of Staphylococcus Aureus
Intervention Drug: Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
Enrollment 216
Recruitment Details  
Pre-assignment Details Only subjects with a positive Baseline culture continued on a treatment arm.
Arm/Group Title All Subjects
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 216
Treated for Positive Baseline Culture 30
Completed 30
Not Completed 186
Arm/Group Title Treatment Group
Hide Arm/Group Description Baseline culture positive for Staphylococcus aureus
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
39.3  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
21
  70.0%
Male
9
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Carrier Rate for Staphylococcus Aureus
Hide Description Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:
All subjects enrolled
Overall Number of Participants Analyzed 216
Measure Type: Number
Unit of Measure: percentage of subjects
20.8
2.Primary Outcome
Title MSSA Clearance Rate
Hide Description Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSSA
Hide Arm/Group Description:
Baseline culture positive for methicillin-susceptible staphylococcus aureus
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of subjects
57.1
3.Primary Outcome
Title MRSA Clearance Rate
Hide Description Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MRSA
Hide Arm/Group Description:
Subjects with Baseline culture positive for methicillin-resistant Staphylococcus aureus
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of subjects
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%)
Total   0/216 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Subjects
Affected / at Risk (%)
Total   0/216 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Clinical Trials Unit Coordinator
Organization: Northwestern University Department of Dermatology
Phone: 312-695-6829
Responsible Party: Dennis West, Northwestern University
ClinicalTrials.gov Identifier: NCT00997139     History of Changes
Other Study ID Numbers: NU-9892
First Submitted: October 15, 2009
First Posted: October 19, 2009
Results First Submitted: April 10, 2012
Results First Posted: May 8, 2012
Last Update Posted: January 5, 2015