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Antibiotic

Rifapentine-Based Regimens for Latent Tuberculosis (ASTERoiD Trial)

Q: Why is Rifapentine most commonly prescribed for a duration of 6 weeks?

Rifapentine administered daily over the course of 6 weeks can be an effective antibacterial therapy for treating <a href="https://www.withpower.com/clinical-trials/mrsa">mrsa</a> infections, late phase tuberculosis.

Q: Is this a widespread clinical trial or is it only happening in a few locations?

Currently, this trial is enrolling patients at 11 locations. These sites are situated in Seattle, San Antonio, Toronto and 8 other cities. If you are interested in participating, please select the location nearest to you to limit travel requirements.

Q: Does this Rifapentine study build on other research of a similar nature?

Rifapentine daily for 6 weeks was trialed in 2011 at Hadassah Hebrew University Medical Center. So far, there have been 294 completed studies with 45 currently active. A high proportion of these ongoing trials are taking place in Seattle, <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>.

Q: Are recruitment efforts for this experiment still ongoing?

That is correct. The clinical trial's listing on the website clinicaltrials.gov shows that it is currently looking for participants. This study was initially posted on August 1st, 2019 and was last updated July 13th, 2020. They are seeking 3,400 individuals total from 11 different sites.

Q: Could you tell me how many study subjects are taking part in this research?

In order to 3400 eligible individuals must participate in this clinical trial at Seattle King County Health Department or San Antonio VA.

Phase 2 & 3

Recruiting

Research Sponsored by Centers for Disease Control and Prevention

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI

Women of child-bearing potential who are not surgically sterilized must agree to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from heterosexual intercourse during study drug treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months from the date of enrollment

Awards & highlights

ASTERoiD Trial Summary

This trial is being conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI).

Who is the study for?

This trial is for people over 12 years old with latent TB infection at high risk of developing active TB, including recent immigrants from high-incidence countries and those in close contact with TB patients. Participants must not be pregnant or breastfeeding, agree to use contraception if applicable, have no history of TB treatment, and not be on certain conflicting medications.Check my eligibility

What is being tested?

The study compares a new short-term (6 weeks) daily treatment using Rifapentine against the standard longer-term (12-16 weeks) treatments for latent TB that include various combinations of Rifapentine, Isoniazid, and Rifampin. The goal is to see if the shorter regimen is just as safe and effective.See study design

What are the potential side effects?

Potential side effects may include liver issues signaled by elevated enzyme levels in blood tests; digestive problems like nausea or upset stomach; allergic reactions such as rashes; flu-like symptoms; discoloration of body fluids; and possible drug interactions.

ASTERoiD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have lung scarring seen on an X-ray but have never been treated for TB.

Select...

I agree to use contraception or abstain from sex during the study if I can have children and am not surgically sterilized.

Select...

I have latent TB without signs of active TB but at high risk of it progressing.

Select...

I am HIV positive with a CD4 count over 100.

ASTERoiD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months from the date of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 months from the date of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months from the date of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old.

Treatment discontinuation due to adverse drug reaction

Secondary outcome measures

Effectiveness among participants < 18 years old.

Effectiveness among participants with human immunodeficiency virus (HIV) infection.

Proportion who complete assigned treatment

+10 more

Other outcome measures

Effectiveness of experimental (6wP) arm and each treatment regimen in the comparator arm: 3HP, 3HR, 4R

Proportion with resistance to rifamycins or isoniazid among persons who develop TB to each regimen in the comparator arm: 3HP, 3HR, 4R.

Proportions of drug discontinuation due to adverse drug reactions in experimental (6wP) arm and each treatment regimen in the comparator arm: 3HP, 3HR, 4R

+1 more

ASTERoiD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 6 weeks of daily rifapentine (6wP)Experimental Treatment1 Intervention

Rifapentine daily for 6 weeks: 600 mg of Rifapentine (RPT) given once daily for 6 weeks

Group II: 12-16 week rifamycin-based regimenActive Control3 Interventions

A 12-16 week rifamycin-based regimen available at the participant's site: "Rifapentine and Isoniazid weekly for 12 weeks" (3HP) or "Rifampin and Isoniazid daily for 12 weeks" (3HR) or "Rifampin daily for 16 weeks" (4R)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionLead Sponsor

875 Previous Clinical Trials

22,474,002 Total Patients Enrolled

8 Trials studying Latent Tuberculosis

37,571 Patients Enrolled for Latent Tuberculosis

British Medical Research CouncilOTHER_GOV

12 Previous Clinical Trials

2,123,168 Total Patients Enrolled

Ibrahim Abubakar, MDStudy ChairUniversity College London Hospitals

Media Library

Rifapentine (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03474029 — Phase 2 & 3

Latent Tuberculosis Research Study Groups: 6 weeks of daily rifapentine (6wP), 12-16 week rifamycin-based regimen

Latent Tuberculosis Clinical Trial 2023: Rifapentine Highlights & Side Effects. Trial Name: NCT03474029 — Phase 2 & 3

Rifapentine (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03474029 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Rifapentine most commonly prescribed for a duration of 6 weeks?

"Rifapentine administered daily over the course of 6 weeks can be an effective antibacterial therapy for treating mrsa infections, late phase tuberculosis."

Answered by AI

Is this a widespread clinical trial or is it only happening in a few locations?

"Currently, this trial is enrolling patients at 11 locations. These sites are situated in Seattle, San Antonio, Toronto and 8 other cities. If you are interested in participating, please select the location nearest to you to limit travel requirements."

Answered by AI

Does this Rifapentine study build on other research of a similar nature?

"Rifapentine daily for 6 weeks was trialed in 2011 at Hadassah Hebrew University Medical Center. So far, there have been 294 completed studies with 45 currently active. A high proportion of these ongoing trials are taking place in Seattle, Washington."

Answered by AI

Are recruitment efforts for this experiment still ongoing?

"That is correct. The clinical trial's listing on the website clinicaltrials.gov shows that it is currently looking for participants. This study was initially posted on August 1st, 2019 and was last updated July 13th, 2020. They are seeking 3,400 individuals total from 11 different sites."

Answered by AI