NCT02262819|CompletedPhase 1FDA Drug
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Sponsor study identifier
Secondary identifiers
interventional
49
1 country
1
Study Start
October 10, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 24, 2019
Actual (reported)Study Completion
April 24, 2019
Actual (reported)Background: \- Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory system. Sometimes people who get sick with staph infection do not get better with standard treatment. These staph infections can be serious and even deadly. Researchers want to find out why some people are more likely to get the infection. Objectives: \- To look at the immune response of the skin when it is exposed to bacteria. Eligibility:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 24, 2019
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2014
Actual (reported)October 10, 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 13, 2014
Actual (reported)April 24, 2019
Actual (reported)April 24, 2019
Actual (reported)Evaluate the local in vivo skin immune response to bacteria.
4 years
Evaluate the keratinocyte responses to bacterial challenge.
4 years
Determine if abnormalities in specific immune pathways, such as IL-17 and vitamin D metabolism, are present in subjects with recognized susceptibility to S. aureus infections.
4 years
Characterize cultured skin bacteria (S. aureus, S. epidermidis, and other skin commensals) with molecular and functional studies.
4 years
Assess the impact of non-steroidal anti-inflammatory drugs (NSAIDs) on skin immune function.
4 years
Characterize blood immune parameters in a cohort of patients with invasive and/or recurrent skin and soft tissue S. aureus infections.
4 years
S. aureus, commensal coagulase-negative staphylococcal species, and Gram-negative commensals, such as Roseomonas and Pseudomonas species
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Gough P, Ganesan S, Datta SK. IL-20 Signaling in Activated Human Neutrophils Inhibits Neutrophil Migration and Function. J Immunol. 2017 Jun 1;198(11):4373-4382. doi: 10.4049/jimmunol.1700253. Epub 2017 Apr 19.
Sastalla I, Williams KW, Anderson ED, Myles IA, Reckhow JD, Espinoza-Moraga M, Freeman AF, Datta SK. Molecular Typing of Staphylococcus aureus Isolated from Patients with Autosomal Dominant Hyper IgE Syndrome. Pathogens. 2017 Jun 6;6(2):23. doi: 10.3390/pathogens6020023.
Ian A Myles, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
49 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2014
First Posted
October 13, 2014
Study Start
October 10, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 24, 2019
Actual (reported)Study Completion
April 24, 2019
Actual (reported)Last Updated
March 30, 2021
Record last verified: 2019-04-24
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Source: ClinicalTrials.gov.
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