Prevalence of Latent Tuberculosis in High Risk Children

Latent Tuberculosis Clinical Trial

Official title:

Prevalence of Latent Tuberculosis in High Risk Children Attending Pediatric Hospital of Assiut University

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03910946
• Other study ID #: latent tuberculosis
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: February 2021

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: nasef s. lemby, physician
• Phone: 01014815079
• Email: nasef_freestyle[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Drug:
• Tuberculin, Purified Protein 5Unt/0.1 mL Solution
Tuberculosis (diagnosis)—Tuberculin, purified protein derivative (PPD) is indicated as a diagnostic aid in the detection of Mycobacterium tuberculosis infection. It is also indicated when BCG vaccination or isoniazid prophylaxis is being considered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Comstock GW, Livesay VT, Woolpert SF. The prognosis of a positive tuberculin reaction in childhood and adolescence. Am J Epidemiol. 1974 Feb;99(2):131-8. — View Citation

Corbett EL, Watt CJ, Walker N, Maher D, Williams BG, Raviglione MC, Dye C. The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med. 2003 May 12;163(9):1009-21. Review. — View Citation

Getahun H, Matteelli A, Chaisson RE, Raviglione M. Latent Mycobacterium tuberculosis infection. N Engl J Med. 2015 May 28;372(22):2127-35. doi: 10.1056/NEJMra1405427. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Latent Tuberculosis in High Risk Young Children Attending Pediatric Hospital of Assiut University	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	one year