2024-518772-32-00RecruitingPhase 2
A randomised, prospective phase II study of pharmacokinetics and safety aspects of higher doses of rifampicin and pyrazinamide in a shortened treatment of mild-to-moderate tuberculosis compared with standard of care
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main aim of the study is to investigate strategies for reducing the length of TB treatment through detailed study of a shorter TB treatment based on higher doses of RIF and PZA, for a selected group of patients with drug-sensitive pulmonary TB.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 8 Oct 2024
- Start date
- 18 Oct 2024
- Lead sponsor
- Region Oestergoetland
- Diseases
- Tuberculosis
- EU CT number
- 2024-518772-32-00
- EudraCT number
- 2019-003721-25
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active tuberculosis of the lungs that responds to the usual TB drugs. They have not yet started treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Active tuberculosis of the lungs, confirmed by a positive culture or a positive PCR test for M. tuberculosis-complex. The record also describes the trial as for mild-to-moderate TB.
- Earlier treatment
- Must be assigned to first-line TB drugs but not yet started them. Cannot have had treatment for active TB in the past 12 months.
- Biomarker or test result
- Positive culture or positive PCR test for M. tuberculosis-complex. No resistance to RIF, INH, PZA or EMB.
Main reasons for not taking part
- Treatment for active TB in the past 12 months
- Resistance to any of the standard TB drugs (RIF, INH, PZA, EMB)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received treatment for active TB in the past 12 months leading up to inclusion in the study
- Resistance to any of the drugs (RIF, INH, PZA, EMB) included in the standard TB treatment according to molecular biological or phenotypic drug susceptibility testing.
Who the study is looking for
- Confirmed active pulmonary tuberculosis, through positive culture or positive PCR test for M.tuberculosis-complex.
- Has provided written consent
- Assigned for TB-treatment (first-line drugs) but not yet started treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Oestergoetland | Linkoping | Sweden | Recruiting |
| Vrinnevisjukhuset I Norrkoeping Region Oestergoetland | Norrkoping | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.