Health TrialsbyHealthPanel

Asymptomatic TB With Innovative Modified Short-course Regimens

ConditionTuberculosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-80
SponsorHuashan Hospital

About this trial

This study is a randomized controlled trial among asymptomatic tuberculosis individuals aiming to assess whether the standard treatment duration can be shortened to 17 weeks without increasing the types or doses of anti-tuberculosis medications or 13 weeks with the high-dose rifapentine and moxifloxacin.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age between 14 to 80 years;

2. Male or female;

3. Willing to provide signed informed consent, or parental consent and participant assent;

4. Individuals with respiratory tract specimen (including sputum/bronchoalveolar lavage fluid/lung tissue) positive for acid-fast bacilli smear/culture/molecular amplification for M. tuberculosis;

Disqualifiers

1. Combined extrapulmonary tuberculosis;

2. Induviduals with extensive lesion (lesion involvement exceeding 50% or the aggregate diameter of all cavities exceeding 6 cm) ;

3. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;

4. Individuals with impaired liver function (alanine transaminase [ALT] or total bilirubin [TBIL] more than 2.5 times the upper limit of normal) or combined with liver cirrhosis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Four-month regimen

    Drug

    The four-month regimen consists of a 17-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 9 weeks with HR. If the sputum culture remains positive at week 8, or if the radiological examination at the end of treatment still shows unclosed cavities, the continuation phase treatment will be extended by an additional 8 weeks.

  • Three-month regimen

    Drug

    Three-month regimen consists of two periods of 13-21 weeks. During the intensive phase (8 weeks), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; pyrazinamide \<50.0kg 1000mg daily, 50.0-70.9kg 1500 mg daily, ≥71kg 2000mg daily. During the continuation phase (5 or 13 weeks based on the culture resultes and radiological manifestations), rifapentine 900 mg daily; moxifloxacin 400 mg daily; isoniazid 300 mg daily; All treatment is taken orally. For rifapentine administration, the daily dosage may be reduced to 600mg if intolerance occurs.

  • Standard regimen

    Drug

    The standardized regimen consists of a 26-week course of standard daily first-line anti-tuberculosis therapy, administered as either fixed-dose combinations or separate bulk drugs, in accordance with the recommendations of Technical Guidelines for Tuberculosis Prevention and Control in China. The treatment comprises an intensive phase of 8 weeks with Isoniazid (H) , Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E), followed by continuation phase of 18 weeks with HR.

Treatment groups

426 Participants
are divided into 3 treatment groups
Group A: Four-month regimenExperimental treatment 1 intervention
Group B: Standardized RegimenActive comparator 1 intervention
Group C: Three-month regimenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Favorable outcome rate in mITT pupulation

To compare the proportion of participants in mITT population achieving favorable outcome at 78 weeks post-randomization.

Time frame
At 78 weeks post-randomization

Secondary outcomes

1

Favorable outcome rate in assessable and PP population

To compare the proportion of participants in assessable population and PP population achieving favorable outcomes at 78 weeks post-randomization.

Time frame
At 78 weeks post-randomization
2

Relapse rate post-treatment

To compare the proportion of relapse rate post-treatment.

Time frame
At 104 weeks post-randomization
3

The proportion of participants with sputum culture conversion

The proportion of participants with sputum culture conversion at 8 weeks post-randomization

Time frame
At 8 weeks post-randomization
4

The proportion of grade 3 or greater adverse events

To evaluate the proportion of participants who experience grade 3 or greater adverse events.

Time frame
From treatment initiation until two weeks after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huashan Hospital

Lead sponsor

University of Toronto

Collaborator

Source ClinicalTrials.gov
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