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Evaluation of Pertussis Disease in Young Infants in India

Evaluation of Pertussis Disease in Young Infants in India â?? A Hospital Based Multi-centric Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/12/022449
Enrollment
400
Registered
2019-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A370- Whooping cough due to Bordetella pertussis

Interventions

None listed

Sponsors

Dr Monjori Mitra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 And o Absence of laboratory confirmation; And o No epidemiologic linkage to a laboratory-confirmed case of pertussis. OR, FOR INFANTS AGED 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 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 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 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).

Exclusion criteria

Exclusion criteria: 1. Parents or guardians who are unwilling to give written informed consent for inclusion in the study. 2. Children in care-institutions and orphanages

Design outcomes

Primary

MeasureTime frame
Number 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

MeasureTime frame
1. Number of probable cases of pertussis as per CDC case classification in the total number of hospitalized ARI cases during the study period 2. Socio economic status classification amongst both laboratory confirmed or clinically suspected cases of pertussis.. 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: Number and proportion of cases of RSV/ Influenza or other viruses identified as cases that fit the case definition of pertussisTimepoint: Duration of Hospitalization

Countries

India

Contacts

Public ContactDr Monjori Mitra

Medclin Research Pvt. Ltd.

monjorimr@gmail.com9831075734

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026