Utility of Sputum Induction and Novel Technologies to Improve TB Diagnosis in a High HIV Prevalence Primary Care Setting

NCT ID: NCT01545661

Last Updated: 2012-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 517 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-05-31

Brief Summary

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.

Detailed Description

Tuberculosis is on the increase in Africa. A key area of weakness in TB control efforts is the inability to make a rapid diagnosis. This is, in part, due to the inability to obtain representative biological samples and the non-availability of cheap, effective, rapid and field-friendly diagnostic tools. Indeed, in HIV positive patients, where the sensitivity of sputum smear is as low as 20%, culture results take several weeks and a significant proportion of patients do not expectorate sputum. Sputum induction for the diagnosis of TB has been evaluated in several studies, has been shown to have a good yield, feasibility and safety when performed correctly, and with diagnostic comparability to bronchoscopy. Few studies have evaluated the performance of induced sputum outside of the hospital environment and the tolerability, yield and performance outcome of sputum induction in a primary care facility has yet to be evaluated. The objective of this study is two-fold. We seek to evaluate, through a randomized controlled trial, the feasibility, performance outcomes and impact on time-to-diagnosis and -treatment of sputum induction, in a high HIV prevalence primary care setting, for the diagnosis of smear negative/ sputum scarce TB. We 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. We will also evaluate the potential incremental benefit of novel technologies to improve the rapidity and diagnostic yield using induced sputum samples (Xpert MTB/RIF assay, microscopic observation drug susceptibility testing (MODS) and the Genotype MTB DRplus line probe assay).

Conditions

Tuberculosis

Keywords

Tuberculosis; diagnosis; sputum induction; primary care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sputum induction

Enrolled patients receive sputum induction (using ultrasonic nebulisation with hypertonic saline)

Group Type: EXPERIMENTAL

Sputum induction

Intervention Type: PROCEDURE

Ultrasonic nebulisation 3% hypertonic saline nebulised for duration of 20 mins

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.

Group Type: ACTIVE_COMPARATOR

standard routine expectorated sputum

Intervention Type: PROCEDURE

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

Interventions

Sputum induction

Ultrasonic nebulisation 3% hypertonic saline nebulised for duration of 20 mins

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

2. <18 years

3. Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Peter

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan G Peter, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

University of Cape Town

Cape Town, Western Cape, South Africa

Countries

South Africa

References

Peter JG, Theron G, Pooran A, Thomas J, Pascoe M, Dheda K. Comparison of two methods for acquisition of sputum samples for diagnosis of suspected tuberculosis in smear-negative or sputum-scarce people: a randomised controlled trial. Lancet Respir Med. 2013 Aug;1(6):471-8. doi: 10.1016/S2213-2600(13)70120-6. Epub 2013 Jul 19.

Reference Type: DERIVED

PMID: 24429245 (View on PubMed)

Other Identifiers

SINET study

Identifier Type: -

Identifier Source: org_study_id