Ignite Creation Date:
2024-05-06 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02758236
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2016-04-04
Brief Title:
Tuberculosis Research of INA-RESPOND On Drug Resistance
Sponsor:
Ina-Respond
Organization:
Ina-Respond
Study Overview
Official Title:
Tuberculosis Research of INA-RESPOND On Drug Resistance
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIPOD
Brief 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
Detailed 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 MTBRIF as TB diagnostic tests against culture result
3 To estimate the sensitivity and specificity of Xpert MTBRIF 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 eg Beijing
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 MTBRIF as TB diagnostic tests against culture result
3 To estimate the sensitivity and specificity of Xpert MTBRIF 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 eg Beijing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1263-2311 | OTHER | WHO UTN Number | None |