Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783727
Status:
TERMINATED
Last Update Posted:
2023-12-13
First Post:
2021-03-02
Brief Title:
PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis
Sponsor:
Research Center Borstel
Organization:
Research Center Borstel
Study Overview
Official Title:
Personalized Therapy Durations Defined by the Blood RNA-based Model for Individualizing Treatment in Multidrug-Resistant Tuberculosis
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in WHO recommendations for standard of care control arm availability of new shorter treatment regimens for MDR-TB war in Ukraine where two study sites are located key trial team members left the team
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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
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
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