New all-oral treatment for rifampicin-resistant tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The INSPIRE-TB study evaluates the efficacy and safety of seven different 9-month oral treatment regimens for patients with rifampicin-resistant tuberculosis (RR-TB) who are susceptible to fluoroquinolones. This pragmatic, multicenter, randomized, controlled trial compares these experimental regimens to a standard of care regimen. The study also includes a specific regimen for patients with pre-XDR TB. Participants will undergo molecular drug susceptibility testing to tailor their treatment and minimize toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status;
2. Pulmonary TB with rifampicin resistance diagnosed with either WHO-approved rapid molecular diagnostic test or phenotype drug susceptibility test (within 60 days prior to randomisation) ;
3. Signed informed consent form (ICF).

Exclusion Criteria:

1. Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;
2. Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB;
3. Patients known to be pregnant or breastfeeding at the time of enrollment;
4. Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;
5. Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.

Where it's running

• Guiyang Public Health Treatment Center
  Guiyang, Guizhou, China Recruiting
• People's Hospital of Qiandongnan
  Kaili, Guizhou, China Recruiting
• The Third People's Hospital of Liupanshui
  Liupanshui, Guizhou, China Recruiting
• Affiliated Hospital of Zunyi Medical University
  Zunyi, Guizhou, China Recruiting
• Huashan Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Wenhong Zhang, PHD — Huashan Hospital
• Study coordinator: Feng Sun, Dr.
• Email: feng.sun@nmcid.org.cn
• Phone: (086)15921403893

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Understanding the natural history of tuberculosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.