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CTRI Number  CTRI/2024/07/070880 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational study to understand viral causes of childhood respiratory illnesses in India and build capacity for their prevention, control, and management  
Scientific Title of Study   A collaborative network on respiratory disease epidemiology in India and capacity building 
Trial Acronym  RespIND-Net 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Temsunaro Rongsen Chandola 
Designation  Senior Scientist and Senior Deputy Director 
Affiliation  Society for Applied Studies 
Address  45, Kalu Sarai, Ground Floor
Infectious Diseases Department New Delhi
South
DELHI
110016
India 
Phone  9810804824  
Fax    
Email  naro@sas.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uma Chandra Mouli Natchu 
Designation  Senior Scientist and Deputy Director 
Affiliation  Society for Applied Studies 
Address  45, Kalu Sarai, Ground Floor
Infectious Diseases Department New Delhi
South
DELHI
110016
India 
Phone  9971000489  
Fax    
Email  unatchu@sas.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Temsunaro Rongsen Chandola 
Designation  Senior Scientist and Senior Deputy Director 
Affiliation  Society for Applied Studies 
Address  45, Kalu Sarai, Ground Floor
Infectious Diseases Department New Delhi
South
DELHI
110016
India 
Phone  9810804824  
Fax    
Email  naro@sas.org.in  
 
Source of Monetary or Material Support  
DBT/Wellcome Trust India Alliance, Department of Biotechnology, CGO Complex, Block No. 2, Lodhi Road, New Delhi-110003. India 
 
Primary Sponsor  
Name  Society For Applied Studies 
Address  45 Kalu Sarai, New Delhi-110016 India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Moorthy  Christian Medical College  Dept. Of Clinical Virology, 9th Floor,ASHA Building, Ida Scudder Road, Vellore, Tamil Nadu- 632004
Vellore
TAMIL NADU 
9944355383

maheshmoorthy@cmcvellore.ac.in 
Dr Ashish Bavdekar  King Edward Memorial Hospital Research Centre   Vadu Rural Health Program, Vadu Budruk, Shirur and TDH ground Floor, Room number 02, Department of Pediatrics, KEM Hospital, Sardar Moodliar Road, Rasta Peth
Pune
MAHARASHTRA 
9822056174

a.bavdekar@kemhrcpune.org 
Dr Temsunaro Rongsen Chandola  Society for Applied Studies   Infectious Diseases Department, Ground Floor, 45, Kalu Sarai, New Delhi, 110016
South
DELHI 
9810804824

naro@sas.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Review Committee Society for Applied Studies  Approved 
Institutional Review Board, Christian Medical College  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  14.00 Day(s)
Gender  Both 
Details  1.Live birth
2.Available for enrolment within 14 days of birth
3.Family planning to stay in the study area until 2 years after childbirth
4.Parental consent for participation of their child
Tier 2
1.Under-five children hospitalized for following respiratory infection symptoms, cough, shortness of breath with RR more than 60 for infant below 2 months, more than 50 for infants 2-12 months and more than 40 for children above 1 year, onset within the past 10 days
2.Contact at 90 days after discharge is feasible
3.Additional criteria for infants 0-6 months age, Apnoea, Sepsis, fever (more than equal to 37.5°C) or hypothermia (less than 35.5°C), shock (lethargy, fast breathing, cold skin, prolonged capillary refill, or fast weak pulse), seriously ill with no apparent cause
4.Parental consent for participation of their child 
 
ExclusionCriteria 
Details  1.Twins or triplets
2.Documented birth weight under 1500 grams or weight under 1500 grams at enrolment
3.Gestational age less than 32 weeks
4.HIV positive or born to women with known HIV infection
For Tier 2:
1.Presenting complaints/diagnosis for hospitalization are non-respiratory
2.Respiratory infection is healthcare associated i.e. presenting complaints of cough or shortness of breath began 48 hours after admission.
3.Diagnosed case of HIV or primary immunodeficiency
4.Children receiving chemotherapy or immunomodulator therapy
5.Children with major congenital anomalies affecting the cardiovascular, neural and respiratory system
6. Others - as per investigator evaluation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the burden (incidence) of ARI and ALRI and the relative contribution of the viral causes (cumulative and individually) in ALRI  24 months 
 
Secondary Outcome  
Outcome  TimePoints 
To understand mono vs co-infections, spectrum of illness & seasonal & spatial trends.  24 months 
To determine predictors of severe disease, case fatality & disease outcomes, long-term sequelae among children with ARI & ALRI  24 months 
To study awareness & practices, treatment seeking behaviours & antibiotic use related to ARI & ALRI using mix of qualitative & quantitative methods  24 months 
 
Target Sample Size   Total Sample Size="2482"
Sample Size from India="2482" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is an observational, prospective, multi-site study which will be conducted in the community and hospitals at three sites in the country, namely, SAS Delhi, KEMHRC Pune and CMC Vellore to improve understanding of the epidemiology of Acute Respiratory Illnesses (ARI) and Acute Lower Respiratory Infections (ALRI) in under-five children.  

We will use a two-tiered approach to capture the complete spectrum of illness. The community- based surveillance will provide information on  mild to moderate illness while the hospital-based surveillance will provide information on severe disease.

A cohort of 335 newborns within 14 days of birth will be enrolled from the community at each site and be actively followed up for a period of two years. Active weekly contacts will be made for each child under surveillance to identify symptoms of PSBI or ARI from birth up for 24 months. For each episode of ARI or PSBI in a child, daily contact will be established and continued until resolution of the ARI or PSBI episode. Nasopharyngeal (NP) swab will be collected from the child with ARI or PSBI at home or at study clinic within 5 days of symptom onset. In children with pneumonia or ALRI, the collected NP swabs will be sent to the central lab for multiplex rt-PCR assay to test for the viral pathogens. Also, a blood sample (3 mL) will be collected at 4-6 weeks from onset of the episode to ascertain antibody response to the infection.

Blood specimen will be collected from the mother after live child birth within 14 days and from the child in the first year of life at 3, 6 and 9 months (from 1/3 of the cohort at each time point)  and at 24 months age from the entire cohort for serosurvey of RSV and Flu infections.

Hospital-based surveillance will be conducted in the secondary/tertiary healthcare facilities of the three study sitesThe aim of the hospital-based surveillance is to assess the burden of illnesses due to viral respiratory pathogens which contribute to SARI/sepsis related hospitalizations in under five children. A cohort of 514 children less than 5 years of age hospitalized with SARI will be enrolled at each site over a period of two years. Nasopharyngeal swab will be collected from the respiratory tract of all participants. To study long-term sequelae of disease, all the children hospitalized with severe ARI will be contacted at 90 days after discharge

To study household transmission patterns, a household sub-study will be conducted in the community cohort. Information on symptoms  of respiratory illness in the preceding and following 2 weeks and weekly NP swabs for 2 consecutive weeks, from household contacts of the index child with pneumonia or ALRI will be collected. All members residing in the household will be considered as household contacts.

The socio-cultural practices in the community related to ARI in children including awareness, practices, treatment seeking behaviour, facilitators, and barriers will be studied.

The outcome of the study is to determine the burden of ARI and ALRI and the relative contribution of the viral causes in ALRI, single vs co-infections, spectrum of illness and seasonal and spatial trends.

The study also aims to determine predictors of severe disease, case fatality and disease outcomes, long-term sequelae among children with ARI and ALRI; along with studying awareness and practices, treatment seeking behaviours and antibiotic use related to ARI and ALRI using mix of qualitative and quantitative methods.

 
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