NCT01585532

Brief Summary

Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

1.6 years

First QC Date

April 13, 2012

Last Update Submit

November 3, 2015

Conditions

Tuberculosis

Keywords

TuberculosisUrineNucleic acidAlereBorstel

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity

    ROC analysis to determine the best specificity and sensitivity to differentiate between patients with tuberculosis and patients with an alternative diagnosis

    On admission to hospital

Study Arms (2)

TB suspects with alternative final diagnosis

Confirmed tuberculosis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or confirmed tuberculosis

You may qualify if:

  • Suspected or confirmed tuberculosis
  • Age \>18 years
  • informed consent obtained

You may not qualify if:

  • Previous participation in the study
  • Simultaneous participation in a clinical trial investigating a new drug
  • Inability to give consent
  • Member of a vulnerable study population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center Borstel

Borstel, Schleswig-Holstein, 23845, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Sputum Blood

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 26, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

DE(1)