NCT04055441

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 6, 2019

Last Update Submit

August 11, 2019

Conditions

Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • 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 )

    baseline

Secondary Outcomes (1)

  • sputum culture conversion

    baseline

Other Outcomes (1)

  • time to sputum conversion

    baseline

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.

You may not qualify if:

  • Patients less than 18 ys. loss of patient follow-up . extrapulmonary tuberculosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 25905930BACKGROUND

  • Simon K. [Primary pulmonary tuberculosis in adults]. Munch Med Wochenschr. 1970 May 22;112(21):999-1003. No abstract available. German.

    PMID: 5310017BACKGROUND

  • Pirronti T, Cecconi L, Sallustio G, Meduri A, Macis G. Diagnostic imaging of pulmonary tuberculosis. Rays. 1998 Jan-Mar;23(1):93-114. English, Italian.

    PMID: 9673139BACKGROUND

  • Huchon G. [Tuberculous infection and pulmonary tuberculosis in adults]. Rev Mal Respir. 1997 Dec;14 Suppl 5:S49-59. French.

    PMID: 9496591BACKGROUND

  • Assao 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.

    PMID: 31010756BACKGROUND

  • Cai 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.

    PMID: 31378821BACKGROUND

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • amani omar, professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa hussien kilany, resident

CONTACT

01064123545docmero1693@gmail.com

yousef ahmed yousef, professor

CONTACT

01025033083yousefahmad72@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 13, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

August 13, 2019

Record last verified: 2019-08