Tuberculosis Research of INA-RESPOND On Drug Resistance

Lung Tuberculosis Clinical Trial

— TRIPOD  

Official title:

Tuberculosis Research of INA-RESPOND On Drug Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758236
• Other study ID #: INA102
• Secondary ID: U1111-1263-2311
• Status: Completed
• Start date: February 13, 2017
• Est. completion date: April 26, 2021

Study information

• Verified date: May 2024
• Source: Ina-Respond
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be enrolled in the study. The signed informed consent will designate their willingness to participate on this study.

Description:

This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be enrolled in the study. The signed informed consent will designate their willingness to participate on this study. Enrolled subjects will produce the sputum for bacteriological examination of M. tuberculosis by AFB, culture and Xpert. The sputum will also be tested by Xpert for drug resistance test. If the culture is positive, conventional DST will be performed, and M. tuberculosis isolates will be stored for spoligotyping and for future research on TB. All bacteriologicaly confirmed subjects will be followed for outcome assessment.

For all enrolled subjects chest X-ray results, demographic data, TB co-morbidities, symptoms, nutritional status, treatment regimens, compliance and outcome will be collected. In addition, sputum, blood and urine will also be collected for storage.

To estimate the proportion of MDR-TB amongst new and previously treated TB cases.

1. To evaluate accuracy of clinical diagnosis by comparing clinically defined TB to laboratory confirmed TB.

2. To compare AFB and Xpert MTB/RIF as TB diagnostic tests against culture result.

3. To estimate the sensitivity and specificity of Xpert MTB/RIF in detecting Rif susceptibility against DST.

4. To estimate the proportion of cured, completed, failed, died and lost to follow up as treatment outcomes on DS-TB and DR-TB cases

5. To evaluate the association of treatment success (cured or completed) with the following data:

1. Demographics (age, sex)

2. TB contact history

3. Smoking habit

4. Treatment seeking behavior

5. Co-morbidities (HIV, DM)

6. Primary and secondary drug resistance

7. Symptoms

8. Cavitary disease

9. Nutritional status

10. Treatment regimens

11. Patient reported compliance

12. Numbers of bacteria by AFB test

13. TB strains (e.g Beijing)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: April 26, 2021
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suspected of having pulmonary TB

• Cough = 2 weeks

• At least one other TB clinical symptom

• Fever

• Unexplained weight loss

• Loss of appetite

• Hemoptysis

• Shortness of breath

• Chest pain

• Night sweats

• Fatigue

• Suggestive TB on chest x-ray based on pulmonologist or internist consultant of pulmonology opinion

• Age = 18 years' old

• Willing to be treated or evaluated at study site

• Willing to have specimens stored for use in future studies

• Patient denies having TB treatment for more than 7 days in the last 1 month (30 days).

Exclusion Criteria:

Pregnancy or any serious condition includes, but not limited to, liver disease, chronic kidney disease, and psychiatric illness that might interfere with study compliance (based on the clinician judgment).

Related Conditions & MeSH terms

• Lung Tuberculosis
• MDR TB
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Indonesia	Site 520: University of Udayana/Sanglah Hospital	Denpasar	Bali
Indonesia	Site 590: Persahabatan Hospital	Jakarta	DKI Jakarta
Indonesia	Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital	Makassar
Indonesia	Site 600 : Adam Malik Hospital	Medan	North Sumatra
Indonesia	Site 560: University of Diponegoro/ Dr. Kariadi Hospital	Semarang	Central Of Java
Indonesia	Site 570: University of Airlangga/ Dr. Soetomo Hospital	Surabaya	East Of Java
Indonesia	Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital	Yogyakarta

Sponsors (3)

Lead Sponsor	Collaborator
Ina-Respond	National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, The National Institute of Allergy and Infectious Diseases, United States

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases	AFB smear and GeneXpert were performed at the microbiology laboratory of the study site. Culture and drug susceptibility tests were conducted at appointed National TB Program Reference Laboratories.	2 months after enrollment
Secondary	Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up	From 447 subjects with all sputum examination results, only 328 subjects confirmed by bacteriology and the treatment outcome were categorized as followed: Cured; Failed; Died; Treatment completion; Lost to follow up	12- 30 months
Secondary	Factors for Treatment Success.	Protective factors were collected by interview with the subjects. 237 subjects with confirmed bacteriologically and cured or complete treatment were analyzed for this outcome.	12-30 months
Secondary	Factors of Treatment Interruption.	Risk factors of treatment interruption were collected by interview with the subject. 91 subjects were defined as lost to follow-up or treatment failure or died and analyzed for this outcome.	12-30 months
Secondary	TB Case Category	TB category was defined as clinically TB or bacteriologically confirmed TB. 447 subjects with sputum examination were analyzed for this outcome.	12-30 months
Secondary	The Performance of AFB and Xpert MTB/RIF	Assess the sensitivity and specificity of AFB and Xpert MTB/RIF to culture as gold standard.; 312 subjects had positive sputum culture were used for evaluation of sensitivity. Meanwhile, 99 subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and 36 subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity. In total 135 subjects were analyzed to evaluate the specificity.	12-30 months
Secondary	The Performance of Xpert MTB/RIF	Assess the performance of Rifampicin susceptibility results in Xpert MTB/RIF against result in drug susceptible test (DST) as gold standard.; 312 subjects had positive sputum culture were used to assess the performance of Xpert MTB/RIF.; 196 subjects were sensitive to Rif in Xpert MTB/RIF. While 116 subjects had resistant to Rif in Xpert MTB/RIF.	12-30 months