Status:
SUSPENDED
Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide
Lead Sponsor:
University Hospital, Linkoeping
Collaborating Sponsors:
Linkoeping University
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Ho...
Detailed Description
In five sites in Sweden (Linköping, Norrköping, Jönköping, Kalmar and Stockholm), 40 consenting adult patients with mild to moderate drug-susceptible pulmonary TB will be recruited. The term Actual St...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Not able to provide informed consent/unable to assimilate study information
- Concomitant infectious disease that requires treatment
- 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
- On-going liver disease including hepatitis and elevated transaminase levels \>x5 upper normal limit
- Porphyria
- Drug-drug interaction between concomitant drugs and rifampicin that could not be bridged by dose-adjustment of the concomitant drug
- Jaundice
- Acute gout
- Treatment of active TB during the last year
- Drug resistance to RIF, INH, PZA or EMB
- 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
- Immunosuppressive condition
- Heart failure (NYHA class III and IV)
- Renal failure with estimated glomerular filtration rate (eGFR) \<50 mL/min
- Dysregulated diabetes mellitus
- Alcohol and drug abuse
- Weight \<35 kg or \>90 kg
- Participation in other clinical trial (investigating a drug) within the last 30 days prior to study inclusion
- 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
Key Trial Info
Start Date :
November 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04694586
Start Date
November 30 2022
End Date
May 31 2026
Last Update
January 5 2024
Active Locations (1)
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1
Linköping University Hospital
Linköping, Sweden, S-581 85