NCT04694586Felfüggesztve2. fázis
Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide
A Prospective Multicenter Phase II-study: Pharmacokinetics and Safety of High-Dose Rifampicin and Pyrazinamide in a Shorter Tuberculosis Treatment Compared With Standardized Treatment in Patients With Mild to Moderate Pulmonary TB
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 17.
Rövid összefoglaló (regiszter, angolul)
Tuberculosis (TB) treatment is long and complex with the risk of poor treatment adherence and treatment failure. Several attempts to shorten treatment of drug-susceptible TB have been unsuccessful. However, recent data support a shortened regimen for mild and moderate pulmonary TB and simultaneous optimization of rifampicin (RIF) and pyrazinamide (PZA). This phase II clinical study aim to investigate a strategy to shorten TB treatment by exploring safety and drug exposure of a high-dose sterilizing TB regimen.
- Állapot (regiszter)
- Felfüggesztve
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2020. nov. 23.
- Kezdés
- 2022. nov. 30.
- Elsődleges befejezés
- 2029. máj. 31.
- Fő szponzor
- University Hospital, Linkoeping
- Betegségek
- Tuberkulózis
- NCT-szám
- NCT04694586
Ki nem vehet részt
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Korábbi kezelés
- Concomitant infectious disease that requires treatment
- Drug-drug interaction between concomitant drugs and rifampicin that could not be bridged by dose-adjustment of the concomitant drug
- Drug resistance to RIF, INH, PZA or EMB
- Alcohol and drug abuse
- Participation in other clinical trial (investigating a drug) within the last 30 days prior to study inclusion
Más betegség
- Known allergy to rifamycins, isoniazid, pyrazinamide, ethambutol or history of severe sideeffect to any of the drugs
- Drug-induced inflammatory liver diseases in medical history
- History of acute liver disease
- Immunosuppressive condition
- Heart failure (NYHA class III and IV)
- Dysregulated diabetes mellitus
Laborértékek
- On-going liver disease including hepatitis and elevated transaminase levels >x5 upper normal limit
- Renal failure with estimated glomerular filtration rate (eGFR) <50 mL/min
Egyéb
- Not able to provide informed consent/unable to assimilate study information
- Porphyria
- Jaundice
- Acute gout
- Treatment of active TB during the last year
- Miliary TB
- Pulmonary TB with smear positivity grade 3 and/or chest X-ray grading equal to advanced TB
- TB in the central nervous system
- Extrapulmonary TB (outside central nervous system) without pulmonary TB
- Pregnancy and breast-feeding
- Weight <35 kg or >90 kg
- Person who the investigator, after consultation with the central contact persons of the study, finds by other reason than the above listed not suitable for study participation
Kiket keres a vizsgálat
- Patient 18 years and older
- Confirmed pulmonary TB (positive Mtb culture or positive polymerase chain reaction (PCR) Mtb-complex)
- Intended to start on first-line TB treatment
- HIV negative
- BMI >17
- Written Informed Consent
- Women of childbearing potential should agree on adequate contraceptives during treatment period and have a negative pregnancy test prior to treatment initiation
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Linkoping University Hospital | Linköping | Svédország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.