Phase 3 Tuberculosis Trial, Recruiting NCT05401071 Sponsor: Huashan Hospital Condition: Tuberculosis
Back to Tuberculosis

Phase 3 Tuberculosis Trial, Recruiting

NCT05401071
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged between 18 and 60 years old
  • People who weigh between 40 and 80 kilograms
  • People who have been diagnosed with pulmonary (lung) tuberculosis that shows up on a sputum smear test and responds to the antibiotic rifampicin
  • People who are willing to sign a consent form agreeing to take part (or, for younger participants, a parent's consent plus the participant's own agreement)
  • Women who have not yet gone through menopause must agree to use effective birth control during the treatment period

Who may not be able to join:

  • People whose tuberculosis has spread outside the lungs to other parts of the body
  • People whose tuberculosis has caused very widespread lung damage (affecting more than 50% of the lungs) or large cavities in the lungs (larger than 4 cm)
  • People whose tuberculosis bacteria are already known to be resistant to any of the following antibiotics: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones
  • People who drink heavily — more than 64 grams of pure alcohol per day for men, or more than 42 grams per day for women
  • People with a low red blood cell count (haemoglobin below 70g/L) or a low platelet count (below 100×10⁹/L)
  • People with liver problems, including fluid on the abdomen, brain changes caused by liver disease, or certain abnormal liver blood test results
  • People with kidney function that is significantly below normal, based on a blood creatinine level more than 1.5 times the upper normal limit
  • People who have already received more than five days of treatment with certain tuberculosis or related antibiotics within the six months before the trial starts (confirm with trial site for the full list of medicines)
  • People with a known history of a heart condition called prolonged QT syndrome, which affects the heart's electrical rhythm
  • People currently taking, or planning to take within six months of joining, certain HIV medicines or specific heart-rhythm medicines (confirm with trial site for the full list of medicines)
  • People with a known allergy or bad reaction to any of the medicines used in the trial
  • People who have AIDS
  • People who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Wenhong Zhang, PhD., Huashan Hospital of Fudan University,Shanghai,China

Phone: (086)15921403893

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Huashan Hospital
Registry
ClinicalTrials.gov
Start date
13 January 2023
Est. completion
1 October 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Treatment success rate of the short regimen during drug treatment and follow-up.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov