Pulmonary TuberculosisNCT04055441
A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
An observational study of Pulmonary Tuberculosis, run by Assiut University.
Trial summary
The objective of the investigator's study is to detect the characteristics, pattern and outcome of pulmonary tuberculosis patients treated at Assiut University Hospital by collecting their demographic, clinical, laboratory and radiological data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.
Who may be able to join
- All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.
Who cannot join
- Patients less than 18 ys. loss of patient follow-up . extrapulmonary tuberculosis.
Trial locations and contacts
No sites are listed yet.
About this study
The objective of the investigator's study is to detect the characteristics, pattern and outcome of pulmonary tuberculosis patients treated at Assiut University Hospital by collecting their demographic, clinical, laboratory and radiological data.
Read the detailed description
Tuberculosis (TB) is a problem of global importance, it is a medical, social and economic disaster of immense magnitude that is occurring over the world
TB remains one of the major health risks associated with morbidity and mortality. Worldwide, about 10 million TB cases have been reported in 2017, and about 1.57 million cases have died The estimated global average risk of infection is 1%, implying approximately 38 million new infections per year among the previously uninfected population .
In Egypt ,researchers have found evidences of tuberculosis in the Egyptian mummies dating from 3000 to 2400 Before Christ and WHO reported that TB is the most important public health problem after hepatitis C , TB disease can affect any organ, but most commonly occurs in the lungs (70%-80%). Pulmonary TB is the most important form of TB infection, because an infection of the lungs is highly contagious due to the mode of droplet transmission .
Patients with TB usually manifest diverse signs and symptoms that vary with age, sex and the associated socio-environmental as well as host factors .
- Conditions
- Pulmonary Tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum smear conversion
type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture )
Measured: baseline
Secondary outcomes (1)
sputum culture conversion
type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture )
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Hussien kilany, Assiut University
- Investigators
- amani omar, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055441
- Sponsor's protocol ID
- pulmonary tuberculosis
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rozenshtein A, Hao F, Starc MT, Pearson GD. Radiographic appearance of pulmonary tuberculosis: dogma disproved. AJR Am J Roentgenol. 2015 May;204(5):974-8. doi: 10.2214/AJR.14.13483.
PubMed 25905930Simon K. [Primary pulmonary tuberculosis in adults]. Munch Med Wochenschr. 1970 May 22;112(21):999-1003. No abstract available. German.
PubMed 5310017Pirronti T, Cecconi L, Sallustio G, Meduri A, Macis G. Diagnostic imaging of pulmonary tuberculosis. Rays. 1998 Jan-Mar;23(1):93-114. English, Italian.
PubMed 9673139Huchon G. [Tuberculous infection and pulmonary tuberculosis in adults]. Rev Mal Respir. 1997 Dec;14 Suppl 5:S49-59. French.
PubMed 9496591Assao Neino MM, Gagara Issoufou MA, Ouedraogo AR, Marcellin KA, Maizoumbou DA, Mamadou S. [The current situation with sputum positive pulmonary tuberculosis in Niamey (Niger)]. Rev Mal Respir. 2019 May;36(5):578-582. doi: 10.1016/j.rmr.2018.07.009. Epub 2019 Apr 19. French.
PubMed 31010756Cai EZ, Chua SM, Tan M, Tambyah PA. Tuberculosis care: enhancing directly observed therapy in a peri-urban, low socioeconomic status neighbourhood. Singapore Med J. 2019 Jul;60(7):334-336. doi: 10.11622/smedj.2019072.
PubMed 31378821
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04055441
- Acronym / sponsor ID
- pulmonary tuberculosis
- Conditions
- Pulmonary Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 13 Aug 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.
The objective of the investigator's study is to detect the characteristics, pattern and outcome of pulmonary tuberculosis patients treated at Assiut University Hospital by collecting their demographic, clinical, laboratory and radiological data.
Detailed description
Tuberculosis (TB) is a problem of global importance, it is a medical, social and economic disaster of immense magnitude that is occurring over the world
TB remains one of the major health risks associated with morbidity and mortality. Worldwide, about 10 million TB cases have been reported in 2017, and about 1.57 million cases have died The estimated global average risk of infection is 1%, implying approximately 38 million new infections per year among the previously uninfected population .
In Egypt ,researchers have found evidences of tuberculosis in the Egyptian mummies dating from 3000 to 2400 Before Christ and WHO reported that TB is the most important public health problem after hepatitis C , TB disease can affect any organ, but most commonly occurs in the lungs (70%-80%). Pulmonary TB is the most important form of TB infection, because an infection of the lungs is highly contagious due to the mode of droplet transmission .
Patients with TB usually manifest diverse signs and symptoms that vary with age, sex and the associated socio-environmental as well as host factors .
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.
Key inclusion criteria (1 listed)
- All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.
Key exclusion criteria (1 listed)
- Patients less than 18 ys. loss of patient follow-up . extrapulmonary tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sputum smear conversion
Time frame: baseline
type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture )
1 secondary outcome
sputum culture conversion
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 25905930Rozenshtein A, Hao F, Starc MT, Pearson GD. Radiographic appearance of pulmonary tuberculosis: dogma disproved. AJR Am J Roentgenol. 2015 May;204(5):974-8. doi: 10.2214/AJR.14.13483.
- Background: PubMed 5310017Simon K. [Primary pulmonary tuberculosis in adults]. Munch Med Wochenschr. 1970 May 22;112(21):999-1003. No abstract available. German.
- Background: PubMed 9673139Pirronti T, Cecconi L, Sallustio G, Meduri A, Macis G. Diagnostic imaging of pulmonary tuberculosis. Rays. 1998 Jan-Mar;23(1):93-114. English, Italian.
- Background: PubMed 9496591Huchon G. [Tuberculous infection and pulmonary tuberculosis in adults]. Rev Mal Respir. 1997 Dec;14 Suppl 5:S49-59. French.
- Background: PubMed 31010756Assao Neino MM, Gagara Issoufou MA, Ouedraogo AR, Marcellin KA, Maizoumbou DA, Mamadou S. [The current situation with sputum positive pulmonary tuberculosis in Niamey (Niger)]. Rev Mal Respir. 2019 May;36(5):578-582. doi: 10.1016/j.rmr.2018.07.009. Epub 2019 Apr 19. French.
- Background: PubMed 31378821Cai EZ, Chua SM, Tan M, Tambyah PA. Tuberculosis care: enhancing directly observed therapy in a peri-urban, low socioeconomic status neighbourhood. Singapore Med J. 2019 Jul;60(7):334-336. doi: 10.11622/smedj.2019072.
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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.
amani omar, professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary 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 1 inclusion and 1 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 13 Aug 2019. 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 marwa hussien kilany, resident (01064123545, docmero1693@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sputum smear conversion (time frame: baseline). 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 NCT04055441, which also lists 6 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 13 Aug 2019.