Tuberculosis Research of INA-RESPOND On Drug Resistance

NCT02758236 | Completed Results

• 2 other identifiers: INA102U1111-1263-2311
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 7

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.

Conditions

Lung Tuberculosis; MDR TB

Outcome Measures

Primary Outcomes (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.

  2 months after enrollment

Secondary Outcomes (6)

• Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up

  12- 30 months

• Factors for Treatment Success.

  12-30 months

• Factors of Treatment Interruption.

  12-30 months

• TB Case Category

  12-30 months

• The Performance of AFB and Xpert MTB/RIF

  12-30 months

Interventions

No Intervention OTHER

No Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ina-Respond: lead
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (7)

Site 520: University of Udayana/Sanglah Hospital

Denpasar, Bali, 80114, Indonesia

Location

Site 560: University of Diponegoro/ Dr. Kariadi Hospital

Semarang, Central of Java, 50244, Indonesia

Location

Site 590: Persahabatan Hospital

Jakarta, DKI Jakarta, 14340, Indonesia

Location

Site 570: University of Airlangga/ Dr. Soetomo Hospital

Surabaya, East of Java, 60286, Indonesia

Location

Site 600 : Adam Malik Hospital

Medan, North Sumatra, 20136, Indonesia

Location

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

Makassar, 90245, Indonesia

Location

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

Yogyakarta, 55284, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 33616229 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Publication Division
• Organization: INA-RESPOND

inapublikasi@ina-respond.net

+62214208693

Study Officials

• Dr. dr. Erlina Burhan, SpP(K), MSc

  Persahabatan Hospital, Jakarta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: May 2, 2016
• Study Start: February 13, 2017
• Primary Completion: November 30, 2018
• Study Completion: April 26, 2021
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (7)