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Bronchial Washings in Sputum Scarce Cases of Pulmonary Tuberculosis

NCT03732014 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-08-23

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary

Sponsors & Collaborators

  • Faisal Faiyaz Zuberi

    lead OTHER

Principal Investigators

  • Bader F Zuberi, FCPS · Dow University of Health Sciences

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-09-01
Completion
2019-11-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732014 on ClinicalTrials.gov