Evaluation of Pertussis Disease in Young Infants in India
- Conditions
- Health Condition 1: A370- Whooping cough due to Bordetella pertussis
- Registration Number
- CTRI/2019/12/022449
- Lead Sponsor
- Dr Monjori Mitra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
Probable
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)
And
o Absence of laboratory confirmation;
And
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.
Confirmed
ï?· Acute cough illness of any duration, with isolation of B. pertussis from a clinical specimen.
OR
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)
And
o Polymerase chain reaction (PCR) positive for pertussis.
OR
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)
And
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).
1. Parents or guardians who are unwilling to give written informed consent for inclusion in the study.
2. Children in care-institutions and orphanages
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber and proportion of laboratory confirmed pertussis (i.e. RT-PCR) among hospitalized infants those who met the clinical case definition as per CDC .Timepoint: Duration of Hospitalization
- Secondary Outcome Measures
Name Time Method 1. Number of probable cases of pertussis as per CDC case classification in the total number of hospitalized ARI cases during the study period <br/ ><br>2. Socio economic status classification amongst both laboratory confirmed or clinically suspected cases of pertussis.. <br/ ><br>3. Clinical profile and complications in lab confirmed and clinically suspected cases of pertussis in two different age strata (0-3 and 4-6 months)Timepoint: Duration of Hospitalization;Exploratory: <br/ ><br>Number and proportion of cases of RSV/ Influenza or other viruses identified as cases that fit the case definition of pertussisTimepoint: Duration of Hospitalization