NCT03042754

Brief Summary

Early diagnosis can contribute to good treatment outcomes and isolate infection control.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

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 Progress77%
Jun 2011Dec 2030

Study Start

First participant enrolled

June 6, 2011

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

19.5 years

First QC Date

February 1, 2017

Last Update Submit

March 14, 2025

Conditions

Tuberculosis

Keywords

LAMXpertMTB/RIFtreatment outcomeMicrobacterial tuberculosis

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of sputum from patients suspected with TB

    2 years

  • Sensitivity of urine LAM from patients suspected with TB

    1 year

Study Arms (1)

suspected TB

OTHER

Patients suspected with TB will be sent for XpertMTB/RIF and urine LAM test

Diagnostic Test: XpertMTB/RIF

Interventions

XpertMTB/RIFDIAGNOSTIC_TEST
suspected TB

Eligibility Criteria

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

You may qualify if:

  • patients with suspected TB
  • patients that can give us sputum and urine specimens

You may not qualify if:

  • refuse to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Rajavithi Hospital

Bangkok, Thailand

Location

Bamrasnaradura Institute

Nonthaburi, 11000, Thailand

Location

Related Links

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Gompol Suwanpimolkul, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

  • Kamon Kawkitinarong, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 3, 2017

Study Start

June 6, 2011

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

only for auditing/monitoring process as needed

Locations

TH(4)