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临床试验/NCT04083092
NCT04083092Unknown不适用

Surveillance of Community-Associated MRSA and Treatment Outcomes of Skin and Soft Tissue Infections in the Ambulatory Setting

Children's Healthcare of Atlanta1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年7月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Number of children with MRSA and MSSA carriage

研究概览

简要总结

The purpose of this study is to obtain information from patients diagnosed with a skin and soft tissue infection (also known as an abscess or 'boil' or 'rising') and determine whether or not MRSA is present in the child's different surface skin areas or nose. We also plan to compare how these infections look in the lab, by identifying in detail parts of the germ that caused the infection or is found on the skin/nose areas

详细描述

Patients come into the Emergency Department for skin and soft tissue infections, which could be caused by a germ not treatable with common medications. This germ is a bacterium called methicillin-resistant Staphylococcus aureus (MRSA). MRSA is a bacterium that has become resistant to certain antibiotics. Scientists and doctors are not sure what causes individuals to develop these infections, but it is believed to be related to the bacteria that might be on a patient's skin or in their nose. Patients will be interviewed by someone from the research team to gather more details about possible risk factors related to MRSA infections. Th interview is expected to last between 10-20 minutes. Nasal (nose), axillary (armpit), throat, and around rectum swabs will be obtained by the research team as follows: Culture swabs (similar to a large Q-tip) will be inserted gently into the front half of each nostril (nare), under each arm, in the throat area, and around the perirectal area (surface skin around rectal opening) either before or after being seen by the emergency room physician. Another culture swab of the patient's skin and soft tissue infection might be taken as part of their usual care for the child's condition or a swab culture will be taken from the infection site by research personnel. A 'culture' swab is a sterile Q-tip like swab which is used to collect potential bacteria from the skin and nose, and then can be used in the laboratory to grow the bacteria collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of skin and soft tissue infections (abscesses and cellulitis)
  • Patient aged >6 months and <21 years

排除标准

  • Currently on antibiotics
  • Unimmunized patients
  • Pertinent co-morbid conditions (immune deficiency, underlying cardiac, skin, GI disorder)

结局指标

主要结局

Number of children with MRSA and MSSA carriage

时间窗: 1 year

We are measuring this by swabbing 5 locations on the body of each study participant. We are swabbing the anterior nares (nostrils), under both axilla (armpits), oropharyngeal area (mouth), skin around the perirectal area, and the actual abscess wound.

Number of children with MRSA and MSSA skin and soft tissue infections

时间窗: 1 year

We are measuring this by collecting wound cultures from all children who present with skin and soft issue infections.

次要结局

  • Number of strains of MRSA and MSSA with unique genomic sequences(1 year)
  • Percent relatedness between MRSA and MSSA protein profiles(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lilly

Pediatric Infectious Disease Specialist

Children's Healthcare of Atlanta

研究点 (1)

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