Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)

Multidrug Resistant Tuberculosis Clinical Trial

— INSPIRE-TB  

Official title:

Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05081401
• Other study ID #: INSPIRE-TB
• Status: Recruiting
• Start date: May 23, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2023
• Source: Huashan Hospital
• Contact: Feng Sun, Dr.
• Phone: (086)15921403893
• Email: aaronsf1125[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of a molecular drug-sensitivity test-guided individualized shorter all-oral regimen composed of 4-5 anti-tuberculosis drugs recommended by WHO in RRTB patients for 9-12 months in real-world practice, in some high RR-TB burden province of China. This study hopes to form a clinical pathway of all oral short-term treatment based on the guidance of rapid molecular drug sensitivity that can be popularized in China, and update the Chinese guidelines of RR-TB treatment management.

Description:

This trial is a multi-centre prospective observational cohort study. The purpose of this study is to evaluate an individualized 9-12 month all-oral regimen in RRTB patients confirmed by phenotypic or molecular rifampicin sensitivity test.

A total of 3000 participants with a shorter all-oral regimen and receiving clinical care at study sites will be estimated. Drug resistance to RIF, FQs, SLIDs, INH, Eto and PZA was evaluated before enrollment. After screening for eligibility, treatment regimen is individually designed in this trial by responsible physicians at study sites based on radiological, clinical, bacteriological as well as drug sensitivity test results. Candidate anti-TB drugs are BDQ, LZD, FQs, Cs, Cfz, Z, Dlm and INH. Follow-up visits are conducted monthly until end of treatment. After end of treatment, follow-up visits were conducted every 3 months for the first 6 months and then every 6 months until 24 months after discontinuation.

The primary objective is to evaluate end of treatment outcomes. Favorable outcomes include cured and treatment completed. Unfavorable outcomes include treatment failed, lost to follow-up and died.

The secondary objective is to assess the median time to sputum culture conversion, frequency of and time to relapse and frequency of recurrence-free survival. Safety evaluations performed are the routine lab tests, blood glucose, hearing, vital signs, electrocardiograph (ECG), reporting of adverse events, physical examinations and chest CT. Adverse events will be monitored and promptly managed during the whole treatment course.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Any patient who are willing to participate and signs informed consent.

2. Any patient with rifampicin resistant tuberculosis confirmed by phenotypic or molecular drug sensitivity test.

Exclusion Criteria:

1. Any regimen that does not conform to a shorter all-oral regimen composed of 4-5 drugs(BDQ, LZD, FQs, Cs, Cfz, Z, Dlm, INH).

2. Combined extrapulmonary tuberculosis(except for tuberculous pleuritis, endobronchial tuberculosis and tubercular lymphadenitis).

Related Conditions & MeSH terms

• Multidrug Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

Other:
• This is a non-intervention observational study.
No applicable intervention. This is a secondary data analysis observational study.

Locations

Country	Name	City	State
China	Guiyang Public Health Treatment Center	Guiyang	Guizhou
China	People's Hospital of Qiandongnan	Kaili	Guizhou
China	The Third People's Hospital of Liupanshui	Liupanshui	Guizhou
China	Huashan Hospital of Fudan University	Shanghai	Shanghai
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of treatment outcomes	End of treatment outcomes: cured, treatment completed, treatment failed, lost to follow-up, died and not evaluated.	At completion of 9-12 months treatment regimen
Secondary	The median time to Sputum Culture Conversion	Time from treatment initiation to the first of two consecutive negative sputum cultures without an intervening positive culture in liquid media.	At completion of 9-12 months treatment regimen
Secondary	Frequency of and time to relapse	Proportion of patients and time to relapse confirmed with radiological, clinical or bacteriological tests during treatment and post-treatment follow-up visits.	2 years after end of treatment
Secondary	frequency of recurrence-free survival	Rate of patients who confirmed absence of radiological, clinical or bacteriological signs of TB post treatment follow-up visits.	6 months, 1 year and 2 years after end of treatment
Secondary	The frequency of and time to grade 3 or greater adverse events	To compare the proportion of patients who experience grade 3 or greater adverse events (graded according to the Division of AIDS severity criteria for adverse events), during treatment or follow-up.	At completion of 9-12 months treatment regimen