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Antibiotic

Rifapentine-Based Regimens for Latent Tuberculosis (ASTERoiD Trial)

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

Must not have

A history of treatment for > 7 consecutive days with a rifamycin or > 30 consecutive days with INH within 2 years prior to enrollment

Receiving concomitant medications that are known to be contraindicated with any study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 months from the date of enrollment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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I am HIV positive with a CD4 count over 100.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with rifamycin for more than 7 days or INH for more than 30 days within the last 2 years.

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I am not on any medications that conflict with the study drugs.

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My TB is resistant to rifamycin antibiotics.

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I am not pregnant, breastfeeding, nor plan to become pregnant soon.

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I weigh less than 25 kg.

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I am HIV positive and on medication that can't be mixed with certain TB drugs.

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I might currently have tuberculosis.

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I have been diagnosed with active tuberculosis.

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I have completed treatment for TB and I do not have HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 months from the date of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 months from the date of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 months from the date of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Effectiveness among participants < 18 years old.

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

Safety (defined as treatment discontinuation due to adverse drug reaction) among participants < 18 years old.

+3 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 13Eligibility criteria met