CClinicalTrials.gg
Status unknownNCT03910946Updated Jun 16, 2020

Prevalence of Latent Tuberculosis in High Risk Children

An observational study in Latent Tuberculosis, sponsored by Assiut University. Status unknown. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
1 Year to 12 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Latent Tuberculosis
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients without active TB sequelae in their CXR

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugTuberculin, 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

    Also known as: mantoux test

06

What researchers measure

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

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 26017823 ↗
  • 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. PubMed 12742798 ↗
  • 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. PubMed 4810628 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03910946
Lead sponsor
Assiut University
Responsible party
nasef safwat lemby (doctor, Assiut University) — Principal investigator
First posted
Apr 10, 2019
Start date
Jul 1, 2020 (estimated)
Primary completion
Jan 2021 (estimated)
Completion
Feb 2021 (estimated)
Last update
Jun 16, 2020

Study contacts

nasef s. lemby, physician
Contact
nasef_freestyle@hotmail.com
01014815079
nagla h. fargaly, professor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion