Improve Treatment Outcomes for Tuberculosis Infection in Tertiary Care Hospitals
Primary Purpose
Tuberculosis
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
XpertMTB/RIF
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring LAM, XpertMTB/RIF, treatment outcome, Microbacterial tuberculosis
Eligibility Criteria
Inclusion Criteria:
- patients with suspected TB
- patients that can give us sputum and urine specimens
Exclusion Criteria:
- refuse to provide written informed consent
Sites / Locations
- Chulalongkorn UniversityRecruiting
- HIV-NAT, Thai Red Cross AIDS Research CentreRecruiting
- Rajavithi HospitalRecruiting
- Bamrasnaradura InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
suspected TB
Arm Description
Patients suspected with TB will be sent for XpertMTB/RIF and urine LAM test
Outcomes
Primary Outcome Measures
Sensitivity of sputum from patients suspected with TB
Sensitivity of urine LAM from patients suspected with TB
Secondary Outcome Measures
Full Information
NCT ID
NCT03042754
First Posted
February 1, 2017
Last Updated
March 22, 2022
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Chulalongkorn University, Bamrasnaradura Infectious Diseases Institute, Rajavithi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03042754
Brief Title
Improve Treatment Outcomes for Tuberculosis Infection in Tertiary Care Hospitals
Official Title
Improve Treatment Outcomes for Tuberculosis Infection in Tertiary Care Hospitals
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2011 (Actual)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Chulalongkorn University, Bamrasnaradura Infectious Diseases Institute, Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Early diagnosis can contribute to good treatment outcomes and isolate infection control.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
LAM, XpertMTB/RIF, treatment outcome, Microbacterial tuberculosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
suspected TB
Arm Type
Other
Arm Description
Patients suspected with TB will be sent for XpertMTB/RIF and urine LAM test
Intervention Type
Diagnostic Test
Intervention Name(s)
XpertMTB/RIF
Primary Outcome Measure Information:
Title
Sensitivity of sputum from patients suspected with TB
Time Frame
2 years
Title
Sensitivity of urine LAM from patients suspected with TB
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with suspected TB
patients that can give us sputum and urine specimens
Exclusion Criteria:
refuse to provide written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pirapon J Ohata, BS
Email
juneohata4@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gompol Suwanpimolkul, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kamon Kawkitinarong, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gompol Suwanpimolkul, MD
First Name & Middle Initial & Last Name & Degree
Kamon Kawkitinarong, MD
Facility Name
HIV-NAT, Thai Red Cross AIDS Research Centre
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pirapon J Ohata, BS
Email
juneohata4@gmail.com
First Name & Middle Initial & Last Name & Degree
Anchalee Avihinsanon, MD, PhD
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pairaj Kateruttanakul, MD
Facility Name
Bamrasnaradura Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weerawat Manosutti, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
only for auditing/monitoring process as needed
Links:
URL
http://www.hivnat.org
Description
Related Info
Learn more about this trial
Improve Treatment Outcomes for Tuberculosis Infection in Tertiary Care Hospitals
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