Burden of tuberculosis-Infection or disease-Among household contacts of a case of tuberculosis in paediatric age group

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:

31939406. 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.

69. 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,

2023. 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.