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TBTC Study 24: Intermittent Treatment of TB With Isoniazid Resistance or Intolerance

NCT00023374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2011-08-03

No results posted yet for this study

Summary

This study is a prospective, open-label, nonrandomized trial using a largely-intermittent, six-month tuberculosis treatment regimen among patients who will not receive isoniazid due to the presence of initial isoniazid resistance or intolerance. Subjects are enrolled after resistance or intolerance to isoniazid has been documented, and are treated for a total of six months (nine months if baseline chest x-ray shows cavitation and 2-month sputum culture is positive) with twice weekly or thrice weekly rifampin, ethambutol, and pyrazinamide.

Conditions

Interventions

DRUG

Rifampin

6mos REZ intermittent

DRUG

Pyrazinamide

6mos REZ intermittent

DRUG

Ethambutol

6mos REZ intermittent

DRUG

REZ

Rif+PZA+EMB given 2 or 3 times weekly for 6 months

Sponsors & Collaborators

Principal Investigators

  • Randall Reves, MD · Denver Health and Hospitals, Denver CO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2006-12-31
Completion
2010-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00023374 on ClinicalTrials.gov