NCT03732014

Brief Summary

This study will be conducted in Ojha Institute of Chest Diseases and Department of Medicine, Dow Medical College, Karachi both affiliated with Dow University of Health Sciences, Karachi, Pakistan after IRB approval. All patients of either gender with clinical suspicion of PTB on history, examination and CXR and not expectorating sputum or less than 1 ml will be included in the study. Patients with extra pulmonary tuberculosis, those with age \< 12 years will be excluded. Demographic data of selected patients including age, gender, contact with PTB patient will be collected. Data will be entered in study proforma. Selected patients will undergo bronchoscopy using Olympus 180 series video bronchoscope. Bronchial Wash will be done and 3 aliquots of BW samples will be collected by suctioning. One part of washing will be immediately inoculated in AFB Culture media and second will be submitted for Xpert MTB/RIF testing. Third part will be centrifuged, and sediment will be subjected to AFB microscopy after staining with Ziehl-Neelsen technique. Results of microscopy and Xpert MTB/RIF will be collected next day, and treatment will be started if MTB comes positive, while results of AFB Culture will be collected after 6 weeks and treatment will be started if not already started on previous reports. Sensitivity/Resistance pattern will be recorded for both Xpert MTB/RIF and ABF Culture. The sample size of 72 was taken for conduct of study. Sample size calculations were done using PASS software version 15.0. Frequency of positive tests will be calculated. Mean age will be calculated according to gender and compared by Student's t-test. Sensitivity \& specificity of tests will be calculated using online calculator by VassarStats. Frequency of positive yield of Xpert MTB/RIF will be compared to that of microscopy by χ2- test. P-value of \<0.05 was considered significant.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

November 4, 2018

Last Update Submit

August 17, 2021

Conditions

Tuberculosis, Pulmonary

Keywords

Bronchial washXpert MTB/RIFAFB CultureAFB microscopyBronchoscopy

Outcome Measures

Primary Outcomes (1)

  • AFB Positivity

    AFB positivity on Xpert RIF/MTB, Culture \& Microscopy

    24 Hours

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sputum-scarce suspected pulmonary TB

You may qualify if:

  • Suspicion of Pulmonary TB on history, examination and CXR
  • Unable to produce sputum

You may not qualify if:

  • extra pulmonary tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ojha Institute of Chest Diseases

Karachi, Sindh, Pakistan

Location

Related Publications (1)

  • Rakotoarivelo R, Ambrosioni J, Rasolofo V, Raberahona M, Rakotosamimanana N, Andrianasolo R, Ramanampamonjy R, Tiaray M, Razafimahefa J, Rakotoson J, Randria M, Bonnet F, Calmy A; MadaXpert Study Group. Evaluation of the Xpert MTB/RIF assay for the diagnosis of smear-negative pulmonary and extrapulmonary tuberculosis in Madagascar. Int J Infect Dis. 2018 Apr;69:20-25. doi: 10.1016/j.ijid.2018.01.017. Epub 2018 Mar 1.

    PMID: 29408360BACKGROUND

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

  • Bader F Zuberi, FCPS

    Dow University of Health Sciences

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Pulmonology

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 6, 2018

Study Start

January 2, 2019

Primary Completion

September 1, 2019

Study Completion

November 30, 2019

Last Updated

August 23, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)