Utility of Sputum Induction and Novel Technologies to Improve TB Diagnosis in a High HIV Prevalence Primary Care Setting (SINET)
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ClinicalTrials.gov Identifier: NCT01545661 |
Recruitment Status
:
Completed
First Posted
: March 7, 2012
Last Update Posted
: December 24, 2012
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Condition or disease | Intervention/treatment | Phase |
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Tuberculosis | Procedure: Sputum induction Procedure: standard routine expectorated sputum | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 517 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Randomised Control Trial of Sputum Induction, and New and Emerging Technologies in a High HIV Prevalence Primary Care Setting |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Sputum induction
Enrolled patients receive sputum induction (using ultrasonic nebulisation with hypertonic saline)
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Procedure: Sputum induction
Ultrasonic nebulisation 3% hypertonic saline nebulised for duration of 20 mins
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Active Comparator: No sputum induction
Enrolled patients randomised to this study arm will receive an observed expectorated sputum collection attempt. Research nurses train study patients on the method of producing sputum spontaneously.
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Procedure: standard routine expectorated sputum
Patients in the control group are trained by the research staff to produce sputum but no device is utilized. Sputum is spontaneously expectorated where possible
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- Time-to-treatment initiation [ Time Frame: Up to 48 days after enrollment ]Time-specific proportion of patients initiated on TB treatment between study arms Time-points to be analysed include 3, 5, 7, 10, 14, 21, 48 days from enrollment.
- Diagnostic yield of sputum culture [ Time Frame: Up to 2 months after enrollment ]
Difference in diagnostic yield of a single sputum TB culture between study arms.
This will compare the single induced or expectorated sputum sample collected at study enrollment.
- Diagnostic yield and accuracy of sputum smear microscopy [ Time Frame: Up to 2 months after enrollment ]
Difference in diagnostic yield and accuracy of a single sputum TB smear between study arms.
This will compare the single induced or expectorated sputum sample collected at study enrollment.
Liquid TB culture will be used as the reference standard for assessment of diagnostic accuracy Fluorescence smear microscopy will be performed on auramine-O stained concentrated samples
- Feasibility of sputum induction in primary care clinics [ Time Frame: 2 years ]Feasibility and robustness of performing sputum induction in primary care clinics (measures include - sputum induction failure rates, turn-around-time, user appraisals and evaluation)
- Safety and tolerability of sputum induction performed in primary care clinics [ Time Frame: 2 years ]Side-effects of sputum induction procedures Number of induced sputum procedures terminated because of patient side-effects and safety
- Diagnostic yield and accuracy of additional diagnostics including Xpert MTB/RIF assay, MODS and Genotype MTBDRplus [ Time Frame: 2 years ]
Difference in diagnostic yield and accuracy of Xpert MTB/RIF, MODS liquid culture and the Genotype MTBDRplus on a single induced or expectorated sputum sample collected at enrollment.
Liquid TB culture will be used as the reference standard for diagnostic accuracy measures.
- Cost-analysis of sputum induction for primary care clinics [ Time Frame: 2 years ]Based on diagnostic accuracy measures of different diagnostic tests between the induced sputum and standard care groups, cost-of-diagnosis will be calculated and compared

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 2x smear negative or sputum scarce TB suspects
- Primary care patient (not referred by doctor)
- Adult patients (>18 years)
- Able to provide informed consent
Exclusion Criteria:
- Not meeting inclusion criteria
- <18 years
- Unable to provide informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545661
South Africa | |
University of Cape Town | |
Cape Town, Western Cape, South Africa, 7945 |
Principal Investigator: | Jonathan G Peter, MBChB | University of Cape Town |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jonathan Peter, Dr, University of Cape Town |
ClinicalTrials.gov Identifier: | NCT01545661 History of Changes |
Other Study ID Numbers: |
SINET study |
First Posted: | March 7, 2012 Key Record Dates |
Last Update Posted: | December 24, 2012 |
Last Verified: | December 2012 |
Keywords provided by Jonathan Peter, University of Cape Town:
Tuberculosis diagnosis sputum induction primary care |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |