Evaluation of the Efficacy and Safety of a 4-month Daily Regimen (2HZPM/2HPM) for Treatment of Pulmonary TB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The development of efficacious, safe, and shorter treatment regimens could significantly improve TB management and treatment success rates. This prospective, 3-year, single arm study is to evaluate the efficacy and safety of a short-course, 4-month regimen including isoniazid(H), pyrazinamide(P), rifapentine (P), and moxifloxacin(M) (2HZPM/2HPM) for the treatment of drug-susceptible, pulmonary tuberculosis, and compared with a historical control group receiving the standard six-month regimen.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB

NCT06526039

Tuberculosis, Pulmonary

NOT_YET_RECRUITING PHASE3

Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial

NCT06727864

Pulmonary Tuberculosis

RECRUITING PHASE3

Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis

NCT02467608

Pulmonary Tuberculosis

COMPLETED PHASE2/PHASE3

Efficacy and Safety of Isoniazid, Rifampicin and Moxifloxacin for the Intensive Phase of Initial Therapy of PTB

NCT04187469

Pulmonary Tuberculosis

UNKNOWN NA

Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

NCT04655794

Adverse Reaction to Drug 3HP

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Shorter regimens have the potential to impact on TB control by reducing TB incidence and mortality, and improve outcomes by increasing patient adherence to treatments and decreasing duration to cure, in addition to reducing costs to the health system and the patient. The purpose of this prospective, three year, single arm study is to evaluate whether a short course, four-month regimen containing rifapentine and moxifloxacin (2HZPM/2HPM) are as effective and/or as tolerable as the standard six-month regimen for the treatment of drug-susceptible, pulmonary tuberculosis (TB). A historical group receiving the standard six-month regimen is used as control at a ratio of 1:2. The pharmacokinetic and pharmacodynamic profile of rifapentine in Asian patients. Analysis of of histocompatibility leucocyte antigen (HLA) associations with adverse events and changes in biomarkers will be done.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis, Pulmonary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The intervention group: all patients recruited into the study will receive the 4-month regimen The comparator group: historical control in those who received the standard 6-month regimen

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking will not be done

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4-month regimen (2HZPM/2HPM)

* Eight weeks of daily treatment with isoniazid (H), pyrazinamide (Z), rifapentine (P), and moxifloxacin (M), followed by
* Nine weeks of daily treatment with isoniazid, rifapentine and moxifloxacin

Group Type EXPERIMENTAL

4-month rifapentine-based regimen

Intervention Type DRUG

8 weeks of isoniazid, pyrazinamide, rifapentine, and moxifloxacin, followed by 9 weeks of isoniazid, rifapentine and moxifloxacin

Standard 6-month regimen (2HERZ/4HR) historical control

a standard, six-month regimen, with

* Eight weeks of daily treatment with isoniazid (H), rifampin (R), pyrazinamide (Z) and ethambutol (E) followed by
* Eighteen weeks of daily treatment with isoniazid and rifampin, with or without ethambutol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

4-month rifapentine-based regimen

8 weeks of isoniazid, pyrazinamide, rifapentine, and moxifloxacin, followed by 9 weeks of isoniazid, rifapentine and moxifloxacin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

rifapentine moxifloxacin priftin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Suspected newly diagnosed pulmonary TB plus one of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for Mycobacterium tuberculosis by culture or "Gene Xpert MTB/RIF" testing, with rifamycin resistance not detected, OR c) histopathologic findings compatible with mycobacterial infection including a positive acid-fast stain
2. Patient with a history of being untreated for 3 years after cure from a previous episode of TB can be included.
3. Age 20 years or older
4. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening is required, and must agree to practice a barrier method of contraception during study drug treatment, or be surgically sterilized or have an intrauterine contraceptive device in place.
5. Laboratory parameters performed at or within 14 days prior to enrollment:

* Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal
* Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal
* Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal or Creatinine clearance (CrCl) level greater than 30 mL/min.
* Serum or plasma potassium level greater than or equal to 3.5 milliequivalent/L
* Hemoglobin level of 7.0 g/dL or greater
* Platelet count of 100,000/mm3 or greater
6. Patient signed a written informed consent

Exclusion Criteria

1. Pregnant or breast-feeding.
2. Unable to take oral medications.
3. Previously enrolled in this study.
4. Received any investigational drug in the past 3 months.
5. More than 14 days of systemic treatment with any antituberculous drugs preceding initiation of study drugs.
6. Known history of prolonged QT syndrome.
7. Suspected or documented TB involving the central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis.
8. Weight less than 40.0 kg.
9. Known allergy or intolerance to any of the study medications.
10. 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.
11. Medical conditions, including HIV infection and others conditions that, in the investigator's judgment, make study participation not in the individual's best interest.
12. Late exclusions: Drug-resistant TB by either rapid sputum based test (Gene Expert) or resistance testing using an indirect susceptibility test in liquid culture to isoniazid, rifampin, ethambutol, pyrazinamide or resistance to moxifloxacin or rifapentine by microdilution agar proportion test.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No