| 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
|
|
|
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
|
|
|
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 sites. The
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. |