Improve Treatment Outcomes for Tuberculosis Infection in Tertiary Care Hospitals

February 26, 2024 updated by: The HIV Netherlands Australia Thailand Research Collaboration
Early diagnosis can contribute to good treatment outcomes and isolate infection control.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is conducted into 2 parts: prospective and retrospective.

The prospective study evaluated the use of Xpert MTB/RIF. The study was conducted at three large tertiary care hospitals: the King Chulalongkorn Memorial Hospital, Rajavithi Hospital and Bamrasnaradura Infectious Diseases Institute. Only pulmonologists and infectious disease physicians with extensive experience in TB participated in the study. Patients who had suspected PTB were enrolled into the study. Expectorated sputum were collected and transferred to the central laboratory, Chulalongkorn Research Center (CRC) Laboratory, King Chulalongkorn Memorial Hospital. Each sample was divided into two parts; one part for the Xpert MTB/RIF (Cepheid) and another part for mycobacterial culture. Drug susceptibility tests for streptomycin, isoniazid, rifampicin and ethambutol were performed with rapid qualitative procedure (BACTEC™ MGIT™ 960 SIRE Kit) and semi-automated system (BACTEC™ MGIT™ 960 System). Discordant results of MGIT and Xpert were retested with the rpoB gene sequencing system. All PTB patients were promptly treated with anti-TB drug regimens as WHO's recommendation. All patients had HIV testing done and CD4 cell counts were obtained for all HIV-infected patients. Antiretroviral treatment and prophylaxis for opportunistic infections were prescribed as standard treatment guideline for patients with HIV/TB co-infection. The patients were followed until completion of TB treatment or change in the diagnosis. The WHO definitions for cure, completed treatment, dead, default or treatment failure were used to define the outcome of treatment.

The authors , therefore, evaluated the utility of Xpert MTB/RIF in Thailand, prior to nation-wide implementation. In summary, our real-life cohort study use Xpert MTB/RIF for early diagnosis of PTB and rifampicin resistance in high TB burden country outside of the African region. The results may be beneficial for guiding the policy makers, especially the National Tuberculosis Programme (NTP) to control TB transmission, as the country move towards universal use of Xpert MTB/RIF.

The retrospective study assessed the urine LAM test which has not been evaluated in non-HIV-infected immunocompromised Asians with disseminated TB and non-disseminated TB (TB located in one organ) but has a poor sensitivity and specificity for detecting pulmonary TB patients without HIV infection. On that account, the authors evaluated the applicability and efficacy of TB diagnosis by using the urine from confirmed cultured TB cases with various immune response conditions, such as HIV-infected, non-HIV-infected and non-HIV-infected immunocompromised patients. The authors found that the sensitivity of the urine LAM in HIV-infected and non-HIV-infected patients were similar to previous reports. This confirmed that the urine LAM cannot be used alone to screen for TB. However, it can be used in conjunction with the culture and AFB smear test for patients co-infected with HIV with very low CD4 count. The urine LAM test is especially helpful in cases where the smear is negative in probable-TB patients. For this reason, the urine LAM test is attractive because it is not invasive, and the samples needed can be easily collected from these types of disseminated patients with and without HIV.

Aside from that, the urine LAM test can be used in those severely ill patients, regardless of HIV infection, where it is difficult to physically collect the sputum and paucibacillary samples. The PPV was over 80% for those infected with HIV and up to 100% in non-HIV-infected patients. For physicians, the PPV is more useful than the sensitivity and specificity of the assay because it will answer the question how likely the patient with a positive result from the urine LAM test will have TB or not. A high PPV can accurately guide the physicians to confidentially prescribe the TB medications which are crucial, especially among co-infected patients that are severely ill. For this reason, the urine LAM test seems to be a great point-of-care test that can easily be incorporated with the AFB smear and culture test for the Asian population. Furthermore, this study demonstrated that a positive urine LAM test result was significantly associated with death, especially those with HIV infection. This association is much stronger in patients with very low CD4 counts. The findings from this study suggest the possible use of the urine LAM test with the AFB smear and culture in resource-limited countries in diagnosing TB in advanced HIV and non-HIV-infected patients with TB. This promising diagnostic tool can increase the yield of TB diagnosis and predict the mortality rate of TB infection, particularly in advanced HIV patients.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Rajavithi Hospital
      • Bangkok, Thailand, 10330
        • Chulalongkorn University
      • Bangkok, Thailand, 10330
        • HIV-NAT, Thai Red Cross AIDS Research Centre
      • Nonthaburi, Thailand, 11000
        • Bamrasnaradura Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • refuse to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: suspected TB
Patients suspected with TB will be sent for XpertMTB/RIF and urine LAM test
Diagnostic test: XpertMTB/RIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of sputum from patients suspected with TB
Time Frame: 2 years
2 years
Sensitivity of urine LAM from patients suspected with TB
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Chulalongkorn University
Rajavithi Hospital
Bamrasnaradura Infectious Diseases Institute

Investigators

  • Principal Investigator: Gompol Suwanpimolkul, MD, Chulalongkorn University
  • Principal Investigator: Kamon Kawkitinarong, MD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2011

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimated)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB NRU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

only for auditing/monitoring process as needed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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