AzTrials
AzTrials

Lung TuberculosisTRIPODNCT02758236

Tuberculosis Research of INA-RESPOND On Drug Resistance

An observational study of Lung Tuberculosis and MDR TB, run by Ina-Respond at 7 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Tuberculosis, MDR TB
How many people
490 participants
Where
7 sitesIndonesia
Study dates
13 Feb 2017to 26 Apr 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Patients suspected of having pulmonary TB
  • Cough ≥ 2 weeks
  • At least one other TB clinical symptom
  • Fever
  • Unexplained weight loss
  • Loss of appetite
Show all 16Show fewer
  • 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).

Who cannot join

  • 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).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Indonesia7 sites

  • Site 520: University of Udayana/Sanglah Hospital

    Denpasar, Bali, 80114

  • Site 590: Persahabatan Hospital

    Jakarta, DKI Jakarta, 14340

  • Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital

    Makassar, 90245

  • Site 600 : Adam Malik Hospital

    Medan, North Sumatra, 20136

  • Site 560: University of Diponegoro/ Dr. Kariadi Hospital

    Semarang, Central of Java, 50244

  • Site 570: University of Airlangga/ Dr. Soetomo Hospital

    Surabaya, East of Java, 60286

  • Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital

    Yogyakarta, 55284

Other trials in Indonesia

About 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.

Read the 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 MTB/RIF as TB diagnostic tests against culture result.
  3. To estimate the sensitivity and specificity of Xpert MTB/RIF 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:
  6. Demographics (age, sex)
  7. TB contact history
  8. Smoking habit
  9. Treatment seeking behavior
  10. Co-morbidities (HIV, DM)
  11. Primary and secondary drug resistance
  12. Symptoms
  13. Cavitary disease
  14. Nutritional status
  15. Treatment regimens
  16. Patient reported compliance
  17. Numbers of bacteria by AFB test
  18. TB strains (e.g Beijing)
Being tested
No Intervention
Medical subject headings
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months after enrollment

Secondary outcomes (6)

  1. 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:

    1. Cured
    2. Failed
    3. Died
    4. Treatment completion
    5. Lost to follow up

    Measured: 12- 30 months

  2. 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.

    Measured: 12-30 months

  3. 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.

    Measured: 12-30 months

  4. TB Case Category

    TB category was defined as clinically TB or bacteriologically confirmed TB. 447 subjects with sputum examination were analyzed for this outcome.

    Measured: 12-30 months

  5. 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.

    Measured: 12-30 months

  6. 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.

    Measured: 12-30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2016 (estimated)
  2. Study start13 Feb 2017
  3. Primary completion30 Nov 2018
  4. Study completion26 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
490 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758236
Sponsor's protocol ID
INA102
Other IDs
U1111-1263-2311
Acronym
TRIPOD
Status last verified
May 2024
First submitted
4 Apr 2016
Last updated
16 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share data

Publications

  • 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.

    PubMed 33616229

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Tuberculosis and MDR TB, run by Ina-Respond at 7 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases (time frame: 2 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02758236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in