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CTRI Number  CTRI/2024/03/064642 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 17/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Burden of tuberculosis-Among household contacts of a case of tuberculosis in paediatric age group 
Scientific Title of Study   Burden of tuberculosis-Infection or disease-Among household contacts of a case of tuberculosis in paediatric age group 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jane David 
Designation  Associate Professor 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  janejackiedavid@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Shrikar Bagal 
Designation  Junior Resident 
Affiliation  Seth G S Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  8652050546  
Fax    
Email  shrikarbagal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shrikar Bagal 
Designation  Junior Resident 
Affiliation  Seth G S Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  8652050546  
Fax    
Email  shrikarbagal@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra, INDIA 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrikar Bagal  Seth G.S. Medical College and KEM Hospital  Department of Paediatrics, Seth G. S. Medical College and KEM Hospital, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 		 8652050546

shrikarbagal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC II, Seth GS Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening of tuberculosis infection or disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Index case: a patient who is in the age group of 1 month to 12 years and has reported to the
healthcare with either microbiologically detected TB or whose chest X-ray is suggestive of
TB or who have been started on AKT on clinical suspicion.
2. Household contacts of index case (Both pediatric & adult): a person who shared the same
enclosed living space for one or more nights or for frequent or extended periods during
the day with the index case during the 3 months before the commencement of the current
treatment episode. 
 
ExclusionCriteria 
Details  1. Household contacts not willing to participate.
2. Pregnant individuals in first trimester. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine frequency of TB positive household contacts in TB positive paediatric patients  At the baseline, 4weeks, and 8weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the challenges faced regarding compliance for screening of household
contacts. 		 At the baseline, 4weeks, & 8weeks. 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 06/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Objectives
Primary objective:
To determine the frequency of TB positive household contacts in TB positive pediatric
patients. As per Paediatric TB management guideline 2022 NTEP, TB positive contacts
are those having positive pulmonary smear.
Secondary objective:
• To determine the challenges faced regarding compliance for screening of household
contacts through CRF.
• To determine whether household contacts are symptomatic or asymptomatic.
Methodology
I)Ethical considerations: The study will follow research ethics guidelines of I.C.M.R in
all of its phases. Approval to conduct the study will be obtained from the Institutional
Ethics Committee of Seth G.S.M.C. & K.E.M. Hospital. Confidentiality of the participants
shall be maintained.
II)Study Site: The study shall be conducted in Department of Paediatrics (including PICU,
Ward 1, Ward 2) of G.S.M.C. & K.E.M. Hospital..
III)Study duration: Total duration of the study will be 18 months. Data will be collected
for the first 15 months after the I.E.C approval and the next 3 months will be used for data
analysis and writing the manuscript.
IV)Study design: It will be a Cross sectional observational study.
V) Study population:
Inclusion criteria:
1. Index case: a patient who is in the age group of 1 month to 12 years and has reported to the
healthcare with either microbiologically detected TB or whose chest X-ray is suggestive of
TB or who have been started on AKT on clinical suspicion.
2. Household contacts of index case (Both pediatric & adult): a person who shared the same
enclosed living space for one or more nights or for frequent or extended periods during
the day with the index case during the 3 months before the commencement of the current
treatment episode.
Exclusion Criteria:
1. Household contacts not willing to participate.
2. Pregnant individuals in first trimester.
VI) Sample size:
Z=z score
p=prevalence
e= margin of error
N=population size
So, by applying the above formula:
Z=1.96
p=0.08
(As per Park’s Textbook of Preventive and Social Medicine [27 ed.] prevalence of new and
relapse cases of tuberculosis in children till 12 years is 8%.) (16)
d=0.05
So, sample size=114
Data Collection
1.Index cases will be screened for inclusion criteria.
2.Inclusion criteria fulfilled.
3.Written informed consent and assent will be taken from eligible parents / legal guardians and
patients.
4.Demographic details of the parents and child will be noted by interviewing the parents by the
investigator and collecting data from child’s indoor paper.
5.Data for socioeconomic status will be obtained by the investigator through interview of parents
and will then be graded by recording it in modified Kuppuswamy scale 2022.
6.Data of index cases and their households will be collected in their respective case record forms.
7.Data analysis.
Data will be collected in 2 sections:
I) Index cases’ data
II) Households’ data
Statistical analysis
Data will be compiled & entered in Microsoft Excel 2013. Analysis will be done in SPSS 25.0.
For quantitative data like age, weight, and duration of symptoms of the index case, and age,
duration of symptoms and average duration of contact with index case of the households Mean,
SD, Median, IQR will be calculated. Frequency & percentage will be calculated for qualitative
data like demographic data, laboratory results, socioeconomic status and history of index cases
and their households. To compare categorical variables like gender, residence of index case and
gender, occupation, type of TB, issues faced during screening of households Pearson Chi square
test & Fisher’s exact test will be used as tests of significance. To compare quantitative variables
unpaired t test (in a normally distributed data) & Mann Whitney U test (in non-normally
distributed data) will be used.
Expected study outcome
This study is mainly aimed to determine frequency of TB positive household contacts in TB
positive paediatric patients and knowing the fact that 1 TB patient can spread infection to 10-15
normal individuals so, I am expecting to trace positive TB cases in households & hence
contribute to prevent further spread of TB in the community and reinfection of paediatric
population and also to improve the compliance to screening for TB.
References
1. Chawla S, Gupta V, Gour N, Grover K, Goel PK, Kaushal P, Singh N, Ranjan R. Active
case finding of tuberculosis among household contacts of newly diagnosed tuberculosis
patients: A community-based study from southern Haryana. J Family Med Prim Care.
2020 Jul 30;9(7):3701-3706. doi: 10.4103/jfmpc.jfmpc_532_20. PMID: 33102353;
PMCID: PMC7567210.
2. Singh J, Sankar MM, Kumar S, Gopinath K, Singh N, Mani K, Singh S. Incidence and
prevalence of tuberculosis among household contacts of pulmonary tuberculosis patients
in a peri-urban population of South Delhi, India. PLoS One. 2013 Jul 26;8(7):e69730.
doi: 10.1371/journal.pone.0069730. PMID: 23922784; PMCID: PMC3724886.
3. Gupta M, Saibannavar AA, Kumar V. Household symptomatic contact screening of
newly diagnosed sputum smears positive tuberculosis patients - An effective case
detection tool. Lung India. 2016 Mar-Apr;33(2):159-62. doi: 10.4103/0970-2113.177445.
PMID: 27051103; PMCID: PMC4797434.
4. Prathiksha G, Daniel BD, Natrajan M. Active case-finding for tuberculosis in India. Natl
Med J India. 2019 Mar-Apr;32(2):90-95. doi: 10.4103/0970-258X.275349. PMID:
31939405.
5. Nair D, Rajshekhar N, Klinton JS, Watson B, Velayutham B, Tripathy JP, Jawahar MS,
Swaminathan S. Household Contact Screening and Yield of Tuberculosis Cases-A Clinic 
Based Study in Chennai, South India. PLoS One. 2016 Sep 1;11(9):e0162090. doi:
10.1371/journal.pone.0162090. PMID: 27583974; PMCID: PMC5008766.
6. Khaparde K, Jethani P, Dewan PK, Nair SA, Deshpande MR, Satyanarayana S, Mannan
S, Moonan PK. Evaluation of TB Case Finding through Systematic Contact Investigation,
Chhattisgarh, India. Tuberc Res Treat. 2015;2015:670167. doi: 10.1155/2015/670167.
Epub 2015 Jul 6. PMID: 26236503; PMCID: PMC4506923.
7. De D, Kinikar A, Adhav PS, Kamble S, Sahoo P, Koli H, Kanade S, Mave V,
Suryavanshi N, Gupte N, Gupta A, Mathad J. Source Case Investigation for Children
with TB Disease in Pune, India. Tuberc Res Treat. 2014;2014:182836. doi:
10.1155/2014/182836. Epub 2014 Aug 27. PMID: 25243086; PMCID: PMC4163291.
8. Morrison J, Pai M, Hopewell PC. Tuberculosis and latent tuberculosis infection in close
contacts of people with pulmonary tuberculosis in low-income and middle-income
countries: a systematic review and meta-analysis. Lancet Infect Dis. 2008 Jun;8(6):359-
68. doi: 10.1016/S1473-3099(08)70071-9. Epub 2008 Apr 29. PMID: 18450516.
9. Fox GJ, Barry SE, Britton WJ, Marks GB. Contact investigation for tuberculosis: a
systematic review and meta-analysis. Eur Respir J. 2013 Jan;41(1):140-56. doi:
10.1183/09031936.00070812. Epub 2012 Aug 30. Erratum in: Eur Respir J. 2015
Aug;46(2):578. PMID: 22936710; PMCID: PMC3533588.
10. Bagcchi, Sanjeet. "WHO’s Global Tuberculosis Report 2022." The Lancet Microbe 4.1
(2023): e20.
11. Chakaya, Jeremiah, et al. "Global Tuberculosis Report 2020–Reflections on the Global
TB burden, treatment and prevention efforts." International journal of infectious
diseases 113 (2021): S7-S12.
12. Dodd PJ, Sismanidis C, Seddon JA. Global burden of drug-resistant tuberculosis in
children: a mathematical modelling study. The Lancet Infectious Diseases.
2016;16(10):1193-201 (http://dx.doi.org/10.1016/S1473-3099(16)30132-3
13. Jilani TN, Avula A, Zafar Gondal A, et al. Active Tuberculosis. [Updated 2023 Jan 26].
In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-
. Available from: https://www.ncbi.nlm.nih.gov/books/NBK513246/
14. World Health Organization. WHO consolidated guidelines on tuberculosis. Module 5:
management of tuberculosis in children and adolescents. World Health Organization,
2022.
15. Current status of treatment of latent tuberculosis infection in India. Saha S, Kumar A,
Saurabh K, et al. https://ijmsweb.com/current-status-of-treatment-of-latent-tuberculosisinfection-
in-india/ Indian J Med Sci. 2020;71:54–59.
16. Park, K. (2023) Parks Textbook of Preventive and Social Medicine. 27th Edition, M/S
Banarsidas Bhanot Publishers, Jabalpur, 209.
17. Reichler MR, Khan A, Sterling TR, Zhao H, Moran J, McAuley J, Bessler P, Mangura B;
Tuberculosis Epidemiologic Studies Consortium Task Order 2 Team. Risk and Timing of
Tuberculosis Among Close Contacts of Persons with Infectious Tuberculosis. J Infect
Dis. 2018 Aug 14;218(6):1000-1008. doi: 10.1093/infdis/jiy265. PMID: 29767733;
PMCID: PMC6534268.

 
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