CTRI/2019/12/022449进行中（未招募）未知
Evaluation of Pertussis Disease in Young Infants in India â?? A Hospital Based Multi-centric Study
Dr Monjori Mitra0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. All hospitalized infants in the age group of 0-6 months with or without fever presenting with either cough/cold or respiratory distress will be identified as potential subjects.
- •2. All potential subjects as per the above criteria will be screened and enrolled as per the CDC case classification below.
- •Case Classification as per CDC, US.
- •In the absence of a more likely diagnosis, a cough illness lasting >=2 weeks, with
- •o At least one of the following signs or symptoms:
- •o Paroxysms of coughing; or inspiratory whoopâ??; or
- •o Post-tussive vomiting; or
- •o Apnea (with or without cyanosis) (FOR INFANTS AGED <1 YEAR ONLY)
- •o Absence of laboratory confirmation;
- •o No epidemiologic linkage to a laboratory-confirmed case of pertussis.
- •OR, FOR INFANTS AGED <1 YEAR ONLY:
- •ï?· Acute cough illness of any duration, with
- •o At least one of the following signs or symptoms:
- •o Paroxysms of coughing; or
- •o Inspiratory whoop; or
- •o Post-tussive vomiting; or o Apnea (with or without cyanosis) And
- •o Polymerase chain reaction (PCR) positive for pertussis.
- •OR, FOR INFANTS AGED <1 YEAR ONLY:
- •ï?· Acute cough illness of any duration, with
- •o At least one of the following signs or symptoms:
- •o Paroxysms of coughing; or
- •o Inspiratory whoop; or
- •o Post-tussive vomiting; or
- •o Apnea (with or without cyanosis) And
- •o Contact with a laboratory-confirmed case of pertussis.
- •ï?· Acute cough illness of any duration, with isolation of B. pertussis from a clinical specimen.
- •ï?· Cough illness lasting >= 2 weeks, with
- •o At least one of the following signs or symptoms:
- •o Paroxysms of coughing; or
- •o inspiratory whoopâ??; or
- •o Post-tussive vomiting; or
- •o Apnea (with or without cyanosis) (FOR INFANTS AGED <1 YEAR ONLY)
- •o Polymerase chain reaction (PCR) positive for pertussis.
- •ï?· Cough illness lasting >= 2 weeks, with
- •o At least one of the following signs or symptoms:
- •o Paroxysms of coughing; or
- •o inspiratory whoopâ??; or
- •o Post-tussive vomiting; or
- •o Apnea (with or without cyanosis) (FOR INFANTS AGED <1 YEAR ONLY)
- •o Contact with a laboratory-confirmed case of pertussis.
- •Case Classification Comments
- •Note: An illness meeting the clinical case definition should be classified as Probable rather than Confirmed if it occurs in a patient who has contact with an infant aged less than 1 year who is Polymerase Chain Reaction (PCR) positive for pertussis and has more than or equal to 1 sign or symptom and cough duration less than 14 days (classified as Probable case).
排除标准
- •1. Parents or guardians who are unwilling to give written informed consent for inclusion in the study.
- •2. Children in care-institutions and orphanages
研究者
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