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

NCT01545661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2012-12-24

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Sputum induction

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

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

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Jonathan G Peter, MBChB · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT01545661 on ClinicalTrials.gov