EVALUATION OF RIFAPENTINE-CONTAINING REGIMEN FOR INTENSIVE PHASE TREATMENT OF PULMONARY TUBERCULOSIS

Not Applicable

• Registration Number: PER-064-11
• Lead Sponsor: IVERSIDAD PERUANA CAYETANO HEREDIA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. SUSPECTED PULMONARY TUBERCULOSIS WITH ACID-FAST BACILLI IN A STAINED SMEAR OF EXPECTORATED OR INDUCED SPUTUM POSITIVE (EXPECTORATED OR INDUCED). PATIENTS PRESENTING EXTRAPULMONARY TUBERCULOSIS ELIGIBLE IF THEY HAVE A POSITIVE SPUTUM CULTURE FOR PULMONARY TUBERCULOSIS. SPUTUM SPITTING TO BE OBTAINED BY NATURAL OR INDUCED; RESULTS OBTAINED RESPIRATORY SECRETIONS OR BRONCHIAL LAVAGE BE INVALID FOR ASSESSMENT OF ELIGIBILITY.
2. COMMITMENT TO ACCESS AN HIV TEST DONE IF YOUR HIV STATUS UNKNOWN OR THE LAST DOCUMENTED TEST WAS NEGATIVE 3 MONTHS BEFORE THE LISTING. REPEAT NOT BE NECESSARY IF HIV SEROLOGY WRITTEN DOCUMENTATION FOR A POSITIVE (ELISA AND WESTERN BLOT POSITIVE OR PLASMA VIRAL LOAD OVER 5000 COPIES / ML) BEFORE SUBMISSION.
3. FIVE (5) DAYS OR LESS OF MULTIPLE TUBERCULOSIS THERAPY IN THE 6 MONTHS PRIOR TO SUBMISSION.
4. SEVEN (7) DAYS OR LESS WITH A FLUOROQUINOLONE TREATMENT FOR 30 DAYS PRIOR TO THE INCLUSION.
5. AGE 18 YEARS.
6. SCORING SCALE OF 70 OR MORE KARNIOSFKY (CASUAL ATTENDANCE REQUIRED BUT IS CAPABLE OF CARRYING OUT THE MOST OF YOUR NEEDS, APPENDIX B).
7. INFORMED CONSENT SIGNATURE.
 

Exclusion Criteria

1. PREGNANCY OR BREAST FEEDING.
2. INTOLERANCE KNOWN TO ANY OF THE STUDY DRUG.
3. DISEASE OR CONDITION CONCURRENT USE ISONIAZID CONTRAINDICATED (INH), RIFAMYCINS, PYRAZINAMIDE (PZA) OR ETHAMBUTOL (EMB). INCLUDED: SEVERE CHRONIC LIVER DISEASE, LIVER DISEASE FROM ANY CAUSE ACUTE AND Acute gouty arthritis.
4. ANTIRETROVIRAL CURRENT OR PLANNED DURING PHASE OF TUBERCULOSIS TREATMENT INTENSIVE OR CYCLOSERINE O TACROLIMUS. CYCLOSERINE AND UNACCEPTABLE TACROLIMUS INTERACTIONS WITH PRESENT RIFAMICINAS_
5. PULMONARY SILICOSIS.
6. CNS TUBERCULOSIS.
7. WEIGHT OF 40 KG OR LESS MORE THAN 85 KG.

Study & Design

• Study Type: Interventional
• Study Design: Not specified