NCT01545661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

2.8 years

First QC Date

July 7, 2011

Last Update Submit

December 21, 2012

Conditions

Tuberculosis

Keywords

Tuberculosisdiagnosissputum inductionprimary care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Diagnostic yield of sputum culture

    Up to 2 months after enrollment

  • Diagnostic yield and accuracy of sputum smear microscopy

    Up to 2 months after enrollment

  • Feasibility of sputum induction in primary care clinics

    2 years

  • Safety and tolerability of sputum induction performed in primary care clinics

    2 years

  • Diagnostic yield and accuracy of additional diagnostics including Xpert MTB/RIF assay, MODS and Genotype MTBDRplus

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Sputum induction

EXPERIMENTAL

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

Procedure: Sputum induction

No sputum induction

ACTIVE COMPARATOR

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.

Procedure: standard routine expectorated sputum

Interventions

Sputum inductionPROCEDURE

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

Sputum induction
standard routine expectorated sputumPROCEDURE

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

No sputum induction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • x smear negative or sputum scarce TB suspects
  • Primary care patient (not referred by doctor)
  • Adult patients (\>18 years)
  • Able to provide informed consent

You may not qualify if:

  • \<18 years
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, 7945, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 24429245DERIVED

MeSH Terms

Conditions

TuberculosisDisease

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan G Peter, MBChB

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 7, 2011

First Posted

March 7, 2012

Study Start

August 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations

ZA(1)