PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-11-01

Brief Summary

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PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic signature-based model compared to the standardised twenty months treatment in a cohort of multidrug-resistant tuberculosis patients.

Detailed Description

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This study is a non-inferiority, prospective, parallel-group open-label randomized controlled trial. Three hundred forty-two HIV-negative patients diagnosed with pulmonary tuberculosis (TB) and starting a new anti-multidrug-resistant tuberculosis (MDR-TB) treatment cycle will be included in the study. Two randomized arms of 171 patients each will be recruited over the two-year period, each patient will be followed-up over the entire course of anti-TB treatment and one year after the end of therapy. Regular study visits will include physical examination, collection of sputum, blood and urine and filling in the study questionnaire. On the collected specimens standard bacteriological and blood tests, as well as extended immunological analysis, will be performed. In the experimental group, an RNA transcriptomic analysis using RNA-Seq technology will also be performed.

In the control arm, the patients will receive a standardised World Health Organization recommended 20 months treatment while in the experimental arm the treatment duration will be guided by the transcriptomic signature-based model.

Treatment outcomes and level of TB relapse and survival within the follow-up period will be compared between the experimental and control arms. The efficacy of biomarker-guided treatment therapy will be assessed by a comparison of the proportions of favourable study outcome between two arms.

Conditions

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Tuberculosis, Pulmonary Tuberculosis, Multidrug-Resistant Bacterial Infections Mycobacterial Infection

Keywords

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tuberculosis multidrug resistance treatment duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

During the treatment, both Participant and Care Provider will be masked but once the treatment end is achieved, they will be unmasked, and study participation is continued.

Study Groups

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Experimental arm

The individualised treatment durations defined by the RNA transcriptomic signature-based model

Group Type EXPERIMENTAL

Individualised treatment duration based on RNA transcriptomic model

Intervention Type DIAGNOSTIC_TEST

Anti-MDR-TB treatment with standard drugs and individual treatment duration guided by the RNA transcriptomic model; may be shorter or longer than standard WHO-recommended treatment duration of 20 months.

Control arm

The locally accepted standard duration of treatment based on the WHO recommendation for treatment of MDR-TB patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Individualised treatment duration based on RNA transcriptomic model

Anti-MDR-TB treatment with standard drugs and individual treatment duration guided by the RNA transcriptomic model; may be shorter or longer than standard WHO-recommended treatment duration of 20 months.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient starting an MDR-TB treatment or within the first 4 weeks after treatment initiation and before culture conversion.
* Rifampicin resistant M. tuberculosis detected in sputum using a nucleic acid amplification test.
* New case of TB or re-treatment.
* Can give informed consent at the point of recruitment.
* Contactable (residing in the area covered by participating TB centres and possessing a landline or a mobile phone).
* Willing to participate for the entire course of the treatment and extensive follow-up.

Exclusion Criteria

* Age \<18 years old.
* Anti-MDR-TB therapy within 6 months prior to the start date of the current treatment cycle.
* HIV infection.
* Non-adherent patient with frequent interruptions.
* Patient in custodianship or guardianship.
* Late exclusion criterion: no positive cultures at inclusion and within the first 3 months of treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Heyckendorf, MD

Role: PRINCIPAL_INVESTIGATOR

Research Center Borstel

Locations

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Research Center Borstel

Borstel, Schleswig-Holstein, Germany

Site Status

Phthisiopneumology Institute Chiril Draganiuc

Chisinau, , Moldova

Site Status

Marius Nasta Pulmonology Institute

Bucharest, , Romania

Site Status

Kharkiv National Medical University

Kharkiv, , Ukraine

Site Status

National Pirogov Memorial Medical University

Vinnytsia, , Ukraine

Site Status

Countries

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Germany Moldova Romania Ukraine

References

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Heyckendorf J, Marwitz S, Reimann M, Avsar K, DiNardo AR, Gunther G, Hoelscher M, Ibraim E, Kalsdorf B, Kaufmann SHE, Kontsevaya I, van Leth F, Mandalakas AM, Maurer FP, Muller M, Nitschkowski D, Olaru ID, Popa C, Rachow A, Rolling T, Rybniker J, Salzer HJF, Sanchez-Carballo P, Schuhmann M, Schaub D, Spinu V, Suarez I, Terhalle E, Unnewehr M, Weiner J 3rd, Goldmann T, Lange C. Prediction of anti-tuberculosis treatment duration based on a 22-gene transcriptomic model. Eur Respir J. 2021 Sep 2;58(3):2003492. doi: 10.1183/13993003.03492-2020. Print 2021 Sep.

Reference Type BACKGROUND

PMID: 33574078 (View on PubMed)

Heyckendorf J, Reimann M, Marwitz S, Lange C; DZIF-TB cohort study group. Pathogen-free diagnosis of tuberculosis. Lancet Infect Dis. 2021 Aug;21(8):1066. doi: 10.1016/S1473-3099(21)00337-6. No abstract available.

Reference Type BACKGROUND

PMID: 34331877 (View on PubMed)

Other Identifiers

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