N/A
N=490
Tuberculosis Research of INA-RESPOND On Drug Resistance
Lung Tuberculosis · MDR TB
Bottom Line
View on ClinicalTrials.gov: NCT02758236 ↗Enrolled (actual)
490
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases — 23; 64 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ina-Respond
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases |
23; 64 | — |
| SECONDARY Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up |
222; 12; 31; 15; 48 | — |
| SECONDARY Factors for Treatment Success. |
143; 204; 125; 146; 175 | — |
| SECONDARY Factors of Treatment Interruption. |
56; 81; 51; 54; 75 | — |
| SECONDARY TB Case Category |
99; 348 | — |
| SECONDARY The Performance of AFB and Xpert MTB/RIF |
269; 117; 304; 99 | — |
| SECONDARY The Performance of Xpert MTB/RIF |
6; 2; 165; 2; 25; 112 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02758236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.