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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-064-11
Enrollment
20
Registered
2011-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

ADULTS SUSPECTED OF HAVING PULMONARY TUBERCULOSIS WHO MEET ELIGIBILITY CRITERIA WILL BE RANDOMIZED TO RECEIVE EIHER THE EXPERIMENTAL INTENSIVE PHASE TUBERCULOSIS TREATMENT REGIMEN OR THE STANDARD INTE

Sponsors

UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Lead Sponsor

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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.

Contacts

Public ContactEduardo Gotuzzo

UNIVERSIDAD PERUANA CAYETANO HEREDIA

eduardo.gotuzzo@upch.pe4823910

Outcome results

None listed

Source: REPEC (via WHO ICTRP)