Trial Outcomes & Findings for Tuberculosis Research of INA-RESPOND On Drug Resistance (NCT NCT02758236)
NCT ID: NCT02758236
Last Updated: 2024-05-16
Results Overview
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.
COMPLETED
490 participants
2 months after enrollment
2024-05-16
Participant Flow
The recruitment period was from February 2017 through November 2018. The study was done at 7 hospitals in Indonesia.
From total target 1357 subjects, only achieved 490 subjects enrolled.
Participant milestones
| Measure |
Presumptive TB
TB patients with cough for 2 weeks or longer with at least one additional TB symptom and a chest x-ray suggestive of TB.
|
|---|---|
|
Overall Study
STARTED
|
490
|
|
Overall Study
COMPLETED
|
447
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
Presumptive TB
TB patients with cough for 2 weeks or longer with at least one additional TB symptom and a chest x-ray suggestive of TB.
|
|---|---|
|
Overall Study
Investigator discretion
|
43
|
Baseline Characteristics
Total excluded was 43 participants
Baseline characteristics by cohort
| Measure |
Presumptive TB
n=447 Participants
TB patients with cough for 2 weeks or longer with at least one additional TB symptom and a chest x-ray suggestive of TB.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Age, Categorical
Between 18 and 65 years
|
426 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Sex: Female, Male
Male
|
274 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
447 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Race (NIH/OMB)
Asian
|
447 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Total excluded was 43 participants
|
PRIMARY outcome
Timeframe: 2 months after enrollmentPopulation: TB cases with bacteriologically confirmed TB with positive MTB culture
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.
Outcome measures
| Measure |
MDR TB Amongst New TB Cases
n=260 Participants
New TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
MDR TB Amongst Previously Treated TB Cases
n=187 Participants
Previously treated TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
Sensitivity Xpert MTB/RIF
Subjects that had positive sputum culture were used for evaluation of sensitivity.
|
Specificity Xpert MTB/RIF
Subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity.
|
|---|---|---|---|---|
|
Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases
|
23 Participants
|
64 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12- 30 monthsPopulation: The proportion of treatment outcomes from all subjects with bacteriologically confirmed (n=328 subjects)
From 447 subjects with all sputum examination results, only 328 subjects confirmed by bacteriology and the treatment outcome were categorized as followed: 1. Cured 2. Failed 3. Died 4. Treatment completion 5. Lost to follow up
Outcome measures
| Measure |
MDR TB Amongst New TB Cases
n=328 Participants
New TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
MDR TB Amongst Previously Treated TB Cases
Previously treated TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
Sensitivity Xpert MTB/RIF
Subjects that had positive sputum culture were used for evaluation of sensitivity.
|
Specificity Xpert MTB/RIF
Subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity.
|
|---|---|---|---|---|
|
Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up
Cured
|
222 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up
Failed
|
12 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up
Died
|
31 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up
Treatment complete
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up
Treatment lost to follow-up
|
48 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-30 monthsPopulation: Treatment success was defined as cured or complete treatment.
Protective factors were collected by interview with the subjects. 237 subjects with confirmed bacteriologically and cured or complete treatment were analyzed for this outcome.
Outcome measures
| Measure |
MDR TB Amongst New TB Cases
n=237 Participants
New TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
MDR TB Amongst Previously Treated TB Cases
Previously treated TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
Sensitivity Xpert MTB/RIF
Subjects that had positive sputum culture were used for evaluation of sensitivity.
|
Specificity Xpert MTB/RIF
Subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity.
|
|---|---|---|---|---|
|
Factors for Treatment Success.
Males
|
143 Participants
|
—
|
—
|
—
|
|
Factors for Treatment Success.
Non-Smoking Group
|
204 Participants
|
—
|
—
|
—
|
|
Factors for Treatment Success.
Normal/overweight (BMI>=18)
|
125 Participants
|
—
|
—
|
—
|
|
Factors for Treatment Success.
New TB cases
|
146 Participants
|
—
|
—
|
—
|
|
Factors for Treatment Success.
Lung lesion in CXR > 2 zones
|
175 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-30 monthsPopulation: 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.
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.
Outcome measures
| Measure |
MDR TB Amongst New TB Cases
n=91 Participants
New TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
MDR TB Amongst Previously Treated TB Cases
Previously treated TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
Sensitivity Xpert MTB/RIF
Subjects that had positive sputum culture were used for evaluation of sensitivity.
|
Specificity Xpert MTB/RIF
Subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity.
|
|---|---|---|---|---|
|
Factors of Treatment Interruption.
Male group
|
56 Participants
|
—
|
—
|
—
|
|
Factors of Treatment Interruption.
Non-smoking group
|
81 Participants
|
—
|
—
|
—
|
|
Factors of Treatment Interruption.
Underweight (BMI<18)
|
51 Participants
|
—
|
—
|
—
|
|
Factors of Treatment Interruption.
Previously treated
|
54 Participants
|
—
|
—
|
—
|
|
Factors of Treatment Interruption.
Lung lesion in CXR >2 zones
|
75 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-30 monthsPopulation: TB category was defined as clinically TB or bacteriologically confirmed TB. 447 subjects with sputum examination were analyzed for this outcome.
TB category was defined as clinically TB or bacteriologically confirmed TB. 447 subjects with sputum examination were analyzed for this outcome.
Outcome measures
| Measure |
MDR TB Amongst New TB Cases
n=447 Participants
New TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
MDR TB Amongst Previously Treated TB Cases
n=447 Participants
Previously treated TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
Sensitivity Xpert MTB/RIF
Subjects that had positive sputum culture were used for evaluation of sensitivity.
|
Specificity Xpert MTB/RIF
Subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity.
|
|---|---|---|---|---|
|
TB Case Category
|
99 Participants
|
348 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-30 monthsPopulation: 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.
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.
Outcome measures
| Measure |
MDR TB Amongst New TB Cases
n=312 Participants
New TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
MDR TB Amongst Previously Treated TB Cases
n=135 Participants
Previously treated TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
Sensitivity Xpert MTB/RIF
n=312 Participants
Subjects that had positive sputum culture were used for evaluation of sensitivity.
|
Specificity Xpert MTB/RIF
n=135 Participants
Subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity.
|
|---|---|---|---|---|
|
The Performance of AFB and Xpert MTB/RIF
|
269 Participants
|
117 Participants
|
304 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: 12-30 monthsPopulation: 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.
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.
Outcome measures
| Measure |
MDR TB Amongst New TB Cases
n=196 Participants
New TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
MDR TB Amongst Previously Treated TB Cases
n=116 Participants
Previously treated TB cases with bacteriologically confirmed TB with positive MTB culture and categorized as having MDR-TB
|
Sensitivity Xpert MTB/RIF
Subjects that had positive sputum culture were used for evaluation of sensitivity.
|
Specificity Xpert MTB/RIF
Subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity.
|
|---|---|---|---|---|
|
The Performance of Xpert MTB/RIF
Xpert resistant
|
25 Participants
|
112 Participants
|
—
|
—
|
|
The Performance of Xpert MTB/RIF
Xpert negative
|
6 Participants
|
2 Participants
|
—
|
—
|
|
The Performance of Xpert MTB/RIF
Xpert sensitive
|
165 Participants
|
2 Participants
|
—
|
—
|
Adverse Events
Presumptive TB
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place