NCT04694586SuspendedPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 23 Nov 2020
- Start date
- 30 Nov 2022
- Primary completion date
- 31 May 2029
- Lead sponsor
- University Hospital, Linkoeping
- Diseases
- Tuberculosis
- NCT number
- NCT04694586
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linkoping University Hospital | Linköping | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.