NCT01693224

Brief Summary

The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults. A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

April 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

September 23, 2012

Last Update Submit

September 23, 2012

Conditions

TuberculosisTuberculosis, PulmonaryTuberculosis, Miliary

Keywords

Tests, DiagnosticMycobacterium tuberculosisMycobacterium tuberculosis antigensTBTuberculosisTuberculosis, PulmonaryTuberculosis, MiliaryLipoarabinomannan

Outcome Measures

Primary Outcomes (4)

  • Sensitivity of the lateral-flow urine LAM assay (LF-LAM)

    * Conventional TB tests (mycobacterial blood \& sputum culture) will be the reference standard used to calculate sensitivity of the LF-LAM test * Sensitivity is defined as TP/(TP+FN), or the number of true positives over (the number of true positives + the number of false negatives) * "true positive" = a positive LF-LAM result in a patient also having ≥1 culture positive for M. tuberculosis * "false negative" = a negative LF-LAM result in a patient also having ≥1 culture positive for M. tuberculosis

    One year

  • Failure rate of the lateral-flow urine LAM assay

    Failure rate expressed as the proportion of lateral flow urine LAM tests that require repeating due to an unevaluable initial result

    One year

  • Inter-reader variability of the lateral-flow urine LAM assay

    Expressed as the percent agreement

    One year

  • Specificity of the lateral-flow urine LAM assay (LF-LAM)

    * Conventional TB tests (blood \& sputum culture) will be the reference standard used to calculate specificity (Sp) of the LF-LAM * Sp=TN/(TN+FP), or #true negatives / (#true negatives + #false positives) * "true negative" = negative LF-LAM in "Not TB" patient * "false positive" = positive LF-LAM in "Not TB" patient * "Not TB" = meets all criteria below * no sputum/blood culture positive for MTB * no smear microscopy positive for acid-fast bacilli * no granulomas/caseous necrosis on histopathology * no clinical response to TB treatment * a plausible alternative diagnosis

    One year

Secondary Outcomes (7)

  • Sensitivity of the ELISA-based urine LAM test

    One year

  • Diagnostic yield (expressed as number of TB cases detected) of various diagnostic strategies (see description)

    One year

  • Time to diagnosis (expressed in days) of various diagnostic strategies (see description)

    One year

  • Accuracy, efficiency, costs, and cost-effectiveness of various combinations of TB diagnostic tests

    One year

  • Satisfaction of lateral-flow urine LAM test operators

    One year

  • +2 more secondary outcomes

Interventions

Alere "Determine" lateral-flow urine lipoarabinomannan assayDEVICE

lateral-flow (point-of-care) urine test to detect the lipoarabinomannan (LAM) component of the M. tuberculosis antigen in the urine of TB suspects, in vitro. Manufacturer: Alere

Also known as: Determine lateral-flow urine LAM TB test
Alere "Clearview" ELISA urine LAM assayDEVICE

ELISA-based urine test to detect the lipoarabinomannan component of the M. tuberculosis antigen in the urine of TB suspects, in vitro. Manufacturer: Alere.

Also known as: Clearview ELISA urine LAM TB test
Cepheid Xpert MTB/Rif assayDEVICE
Also known as: Cepheid Xpert MTB/Rif test

Eligibility Criteria

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

You may qualify if:

  • Informed consent
  • Suspected active tuberculosis
  • Willingness and ability to comply with study procedures
  • Any one or more of the following:
  • Current cough
  • Fever at any time within the preceding 4 weeks
  • Night sweats at any time within the preceding 4 weeks
  • Weight loss within the preceding 4 weeks
  • HIV-positive based on any one or more of the following:
  • written results of a positive HIV antibody test, and/or
  • written results of a positive HIV viral load, and/or
  • documentation in the medical record of positive HIV status by a treating clinician.

You may not qualify if:

  • Multidrug tuberculosis treatment for greater than two days within the previous 60 days
  • Unwillingness or inability to provide a urine sample
  • Known chronic pulmonary condition, e.g. asthma, chronic obstructive pulmonary disease, emphysema
  • Respiratory distress, defined as respiratory rate of \>30 or oxygen saturation \<90%
  • Any specific condition that in the judgment of the investigator precludes participation because it could affect a subject's safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

G.F. Jooste Hospital

Cape Town, Western Cape, South Africa

Location

Town Two Clinic

Cape Town, Western Cape, South Africa

Location

Related Publications (1)

  • Nakiyingi L, Moodley VM, Manabe YC, Nicol MP, Holshouser M, Armstrong DT, Zemanay W, Sikhondze W, Mbabazi O, Nonyane BA, Shah M, Joloba ML, Alland D, Ellner JJ, Dorman SE. Diagnostic accuracy of a rapid urine lipoarabinomannan test for tuberculosis in HIV-infected adults. J Acquir Immune Defic Syndr. 2014 Jul 1;66(3):270-9. doi: 10.1097/QAI.0000000000000151.

    PMID: 24675585DERIVED

MeSH Terms

Conditions

TuberculosisTuberculosis, PulmonaryTuberculosis, MiliaryDisease

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Dorman, MD

    Johns Hopkins University

    STUDY CHAIR

  • Mark Nicol, MBChB, PhD

    University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa

    PRINCIPAL INVESTIGATOR

  • Mischka Moodley, MBChB, DTM&H, FCPath(Micro)SA

    University of Cape Town, Faculty of Health Sciences, Dept. of Medical Microbiology, Cape Town, South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2012

First Posted

September 26, 2012

Study Start

April 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

ZA(2)