18 and older, any sex, with Lung Tuberculosis or MDR TB. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB CasesPrimary· 2 months after enrollment
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.
Group
Value
95% CI
MDR TB Amongst New TB Cases
23
MDR TB Amongst Previously Treated TB Cases
64
Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-upSecondary· 12- 30 months
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
Group
Value
95% CI
Treatment Outcome
222
Treatment Outcome
12
Treatment Outcome
31
Treatment Outcome
15
Factors for Treatment Success.Secondary· 12-30 months
Protective factors were collected by interview with the subjects. 237 subjects with confirmed bacteriologically and cured or complete treatment were analyzed for this outcome.
Males
Group
Value
95% CI
Treatment Success Factors
143
Non-Smoking Group
Group
Value
95% CI
Treatment Success Factors
204
Normal/overweight (BMI>=18)
Group
Value
95% CI
Treatment Success Factors
125
New TB cases
Group
Value
95% CI
Treatment Success Factors
146
Lung lesion in CXR > 2 zones
Group
Value
95% CI
Treatment Success Factors
175
Factors of Treatment Interruption.Secondary· 12-30 months
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.
Male group
Group
Value
95% CI
Treatment Interruption
56
Non-smoking group
Group
Value
95% CI
Treatment Interruption
81
Underweight (BMI<18)
Group
Value
95% CI
Treatment Interruption
51
Previously treated
Group
Value
95% CI
Treatment Interruption
54
Lung lesion in CXR >2 zones
Group
Value
95% CI
Treatment Interruption
75
TB Case CategorySecondary· 12-30 months
TB category was defined as clinically TB or bacteriologically confirmed TB. 447 subjects with sputum examination were analyzed for this outcome.
Group
Value
95% CI
Clinically TB
99
Bacteriologically Confirmed TB
348
The Performance of AFB and Xpert MTB/RIFSecondary· 12-30 months
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.
Group
Value
95% CI
Sensitivity AFB
269
Specificity AFB
117
Sensitivity Xpert MTB/RIF
304
Specificity Xpert MTB/RIF
99
The Performance of Xpert MTB/RIFSecondary· 12-30 months
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.
Group
Value
95% CI
DST Sensitive
6
DST Resistant
2
DST Sensitive
165
DST Resistant
2
DST Sensitive
25
DST Resistant
112
Sponsor's own 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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07353099 — A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
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NCT07429942 — A Study to Learn More About the Treatment of People With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Who Recei
· not yet recruiting
NCT07521917 — Child Abuse and Neglect Awareness Training in Nursing Students
· NA
· not yet recruiting
NCT07319832 — A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
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NCT07425574 — A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ina-Respond
Last refreshed: 16 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02758236.