Latent TuberculosisNCT03910946
Prevalence of Latent Tuberculosis in High Risk Children
An observational study of Latent Tuberculosis, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- Tuberculin, Purified Protein 5Unt/0.1 mL Solution
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients without active TB sequelae in their CXR
Who may be able to join
- children aged under 5 yearsold with one of the following risk factor :
- have diabetes
- have chronic kidney disease or receive haemodialysis
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Latent Tuberculosis in High Risk Children Attending Pediatric Hospital of Assiut University
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
- Conditions
- Latent Tuberculosis
- Being tested
- Tuberculin, Purified Protein 5Unt/0.1 mL Solution
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculin, Purified Protein 5Unt/0.1 mL SolutionDrug
Also called mantoux test
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tuberculin, Purified Protein 5Unt/0.1 mL Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Jul 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nasef safwat lemby, Assiut University
- Investigators
- nagla h. fargaly, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910946
- Sponsor's protocol ID
- latent tuberculosis
- Status last verified
- Jun 2020
- First submitted
- 9 Apr 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 26017823Corbett 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 12742798Comstock 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Latent Tuberculosis in High Risk Children Attending Pediatric Hospital of Assiut University
- ClinicalTrials.gov ID
- NCT03910946
- Acronym / sponsor ID
- latent tuberculosis
- Conditions
- Latent Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic and renal | – | Drug: Tuberculin, Purified Protein 5Unt/0.1 mL Solutionall 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 |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients without active TB sequelae in their CXR
Key inclusion criteria (3 listed)
- have diabetes
- have chronic kidney disease or receive haemodialysis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuberculin, Purified Protein 5Unt/0.1 mL SolutionAlso: mantoux testTuberculosis (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 | Drug | diabetic and renal |
Primary outcome
Prevalence of Latent Tuberculosis in High Risk Young Children Attending Pediatric Hospital of Assiut University
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 26017823Getahun 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.
- Background: PubMed 12742798Corbett 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.
- Background: PubMed 4810628Comstock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nagla h. fargaly, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nasef s. lemby, physician (01014815079, nasef_freestyle@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Latent Tuberculosis in High Risk Young Children Attending Pediatric Hospital of Assiut University (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910946, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.