Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-2311 | Other Identifier | WHO UTN Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
To evaluate accuracy of clinical diagnosis by comparing clinically defined TB to laboratory confirmed TB.
To compare AFB and Xpert MTB/RIF as TB diagnostic tests against culture result.
To estimate the sensitivity and specificity of Xpert MTB/RIF in detecting Rif susceptibility against DST.
To estimate the proportion of cured, completed, failed, died and lost to follow up as treatment outcomes on DS-TB and DR-TB cases
To evaluate the association of treatment success (cured or completed) with the following data:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 12- 30 months |
Not provided
Inclusion Criteria:
Patients suspected of having pulmonary TB
Cough ≥ 2 weeks
At least one other TB clinical symptom
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).
Not provided
Not provided
Not provided
Presumptive TB patients, >=18 years old. This study will analyze 500 subjects bacteriologically confirmed TB (250 new cases and 250 previously treated cases). To obtain the numbers, we estimate to enroll 1357 subjects presumptive TB (1000 new cases and 357 previously treated cases). These numbers are made based on our estimation that 25% of presumptive new TB cases and 70% of presumptive previously treated TB cases will be bacteriologically confirmed.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. dr. Erlina Burhan, SpP(K), MSc | Persahabatan Hospital, Jakarta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 520: University of Udayana/Sanglah Hospital | Denpasar | Bali | 80114 | Indonesia | ||
| Site 560: University of Diponegoro/ Dr. Kariadi Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33616229 | Derived | Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5. |
Not provided
Not provided
No plan to share data
Not provided
Not provided
Not provided
Not provided
From total target 1357 subjects, only achieved 490 subjects enrolled.
The recruitment period was from February 2017 through November 2018. The study was done at 7 hospitals in Indonesia.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
TB patients with cough for 2 weeks or longer with at least one additional TB symptom and a chest x-ray suggestive of TB.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Total excluded was 43 participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | TB cases with bacteriologically confirmed TB with positive MTB culture | Posted | Count of Participants | Participants | 2 months after enrollment |
|
12-30 months
any untoward or unfavorable medical occurrence in a human subject that occurs within 48 hours of a study-related blood draw that is possibly, probably, or definitely related to the blood draw. Any event outside of this 48 hour window period will not be considered an AE for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Presumptive TB | Presumptive TB patients | 65 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Publication Division | INA-RESPOND | +62214208693 | inapublikasi@ina-respond.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 2, 2017 | Dec 14, 2022 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects must be willing to allow storage of sputum, Mtb isolate, whole blood (PAXgene blood , plasma, PBMC), and urine on baseline, month 1, month 2, and end of treatment visit, saliva on baseline and end of treatment visit for use in future studies (for example, host response, spoligotyping, and genetic tests). Serum and whole blood for DNA are collected on baseline visit only.
All samples will be stored at the NIHRD, Mtb isolate, plasma, saliva and urine will also be stored at each site
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Semarang |
| Central of Java |
| 50244 |
| Indonesia |
| Site 590: Persahabatan Hospital | Jakarta | DKI Jakarta | 14340 | Indonesia |
| Site 570: University of Airlangga/ Dr. Soetomo Hospital | Surabaya | East of Java | 60286 | Indonesia |
| Site 600 : Adam Malik Hospital | Medan | North Sumatra | 20136 | Indonesia |
| Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital | Makassar | 90245 | Indonesia |
| Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital | Yogyakarta | 55284 | Indonesia |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Total excluded was 43 participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Total excluded was 43 participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Total excluded was 43 participants | Count of Participants | Participants |
|
|
|
| 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:
| The proportion of treatment outcomes from all subjects with bacteriologically confirmed (n=328 subjects) | Posted | Count of Participants | Participants | 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. | Treatment success was defined as cured or complete treatment. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 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. | TB category was defined as clinically TB or bacteriologically confirmed TB. 447 subjects with sputum examination were analyzed for this outcome. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 12-30 months |
|
|
|
| 447 |
| 0 |
| 447 |
| 0 |
| 447 |
Not provided
Not provided
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Treatment complete |
|
| Treatment lost to follow-up |
|
| Title | Measurements |
|---|
|
| New TB cases |
|
| Lung lesion in CXR > 2 zones |
|
| Title | Measurements |
|---|---|
|
| Previously treated |
|
| Lung lesion in CXR >2 zones |
|
| Xpert resistant |
|