Prevalence of Latent Tuberculosis in High Risk Children

• Conditions: Latent Tuberculosis
• Interventions: Drug: Tuberculin, Purified Protein 5Unt/0.1 mL Solution

• Registration Number: NCT03910946
• Lead Sponsor: Assiut University

Brief Summary

identify the prevalence of latent tuberculosis (according to new guideline ;NICE tuberculosis) among these high risk groups of children and notify ministry of health

Detailed Description

TB is an infectious disease caused by the bacillus Mycobacterium tuberculosis. It typically affects the lungs (pulmonary TB) but can also affect other sites (extrapulmonary TB). The disease is spread when people who are sick with pulmonary TB expel bacteria into the air, for example by coughing. Overall, a relatively small proportion (5-15%) of the estimated 1.7 billion people infected with M. tuberculosis will develop TB disease (active disease) during their lifetime. However, the probability of developing TB disease is much higher among people infected with HIV, and also higher among people affected by risk factors such as under-nutrition, diabetes, smoking and alcohol consumption. Latent tuberculosis infection (LTBI) is defined as a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifest active TB. As there is no "gold standard" test for LTBI, the global burden is not known with certainty; however, up to one third of the world's population is estimated to be infected with M. tuberculosis , and the vast majority have no signs or symptoms of TB disease and are not infectious, although they are at risk for active TB disease and for becoming infectious. Several studies have shown that, on average, 5-10% of those infected will develop active TB disease over the course of their lives, usually within the first 5 years after initial infection . The risk for active TB disease after infection depends on several factors, the most important being immunological status

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-13
• Last Update Posted: 2020-06-16
• Study Start: 2020-07-01
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

children aged under 5 yearsold with one of the following risk factor :

1. have diabetes
2. have chronic kidney disease or receive haemodialysis

Exclusion Criteria

1. All children aged above 12 years old
2. History of recent contact with TB positive patient
3. All children under 5 yearsold without any other risk factor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetic and renal	Tuberculin, Purified Protein 5Unt/0.1 mL Solution	all cases included in the study will be subjected to : Full clinical history to rule out active TB ( history of current prolonged cough, haemoptysis, fever, night sweats, weight loss, chest pain, shortness of breath, fatigue.) Chest x ray TST (tuberculin sensitivity test) : injecting a 0.1 mL of liquid containing 5 TU (tuberculin units) PPD (purified protein derivative) into the top layers of skin of the forearm and read skin tests 48-72 hours after the injection

Primary Outcome Measures

Name	Time	Method
Prevalence of Latent Tuberculosis in High Risk Young Children Attending Pediatric Hospital of Assiut University	one year	To identify the prevalence of latent tuberculosis (according to new guideline ;NICE tuberculosis) among these high risk groups of children and notify ministry of health