Prevalence of Latent Tuberculosis in High Risk Children

NCT03910946 | Unknown

• 1 other identifier: latent tuberculosis
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Latent Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

diabetic and renal

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

Drug: Tuberculin, Purified Protein 5Unt/0.1 mL Solution

Interventions

Tuberculin, Purified Protein 5Unt/0.1 mL Solution DRUG

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

Also known as: mantoux test

diabetic and renal

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients without active TB sequelae in their CXR

You may qualify if:

• children aged under 5 yearsold with one of the following risk factor :
• have diabetes
• have chronic kidney disease or receive haemodialysis

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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. No abstract available.

  PMID: 26017823 BACKGROUND

• 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. doi: 10.1001/archinte.163.9.1009.

  PMID: 12742798 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.aje.a121593. No abstract available.

  PMID: 4810628 BACKGROUND

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• nagla h. fargaly, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

nasef s. lemby, physician

CONTACT

01014815079; nasef_freestyle@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: June 16, 2020

Record last verified: 2020-06