Tuberculosis Clinical Trial
— SINETOfficial title:
A Randomised Control Trial of Sputum Induction, and New and Emerging Technologies in a High HIV Prevalence Primary Care Setting
Verified date | December 2012 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Human Research Ethics Committee |
Study type | Interventional |
This study will investigate the benefit of using Sputum induction for TB diagnosis in a primary care clinic for adult TB suspects that are either unable to produce a sputum sample (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (WHO standard for frontline TB diagnosis). The investigators hypothesize that acquiring an induced sputum sample for smear microscopy and liquid TB culture will decrease time-to-diagnosis and time-to-treatment initiation in smear negative/sputum scarce TB patients in a primary care clinic in a resource-limited high TB HIV prevalent setting.
Status | Completed |
Enrollment | 517 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 2x smear negative or sputum scarce TB suspects 2. Primary care patient (not referred by doctor) 3. Adult patients (>18 years) 4. Able to provide informed consent Exclusion Criteria: 1. Not meeting inclusion criteria 2. <18 years 3. Unable to provide informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
South Africa | University of Cape Town | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time-to-treatment initiation | 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. | Up to 48 days after enrollment | No |
Secondary | Diagnostic yield of sputum culture | 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. |
Up to 2 months after enrollment | No |
Secondary | Diagnostic yield and accuracy of sputum smear microscopy | 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 |
Up to 2 months after enrollment | No |
Secondary | Feasibility of sputum induction in primary care clinics | Feasibility and robustness of performing sputum induction in primary care clinics (measures include - sputum induction failure rates, turn-around-time, user appraisals and evaluation) | 2 years | No |
Secondary | Safety and tolerability of sputum induction performed in primary care clinics | Side-effects of sputum induction procedures Number of induced sputum procedures terminated because of patient side-effects and safety | 2 years | Yes |
Secondary | Diagnostic yield and accuracy of additional diagnostics including Xpert MTB/RIF assay, MODS and Genotype MTBDRplus | 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. |
2 years | No |
Secondary | Cost-analysis of sputum induction for primary care clinics | 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 | 2 years | No |
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