Clinical trial • Phase IV • Infectious Disease

Pyrazinamide for Tuberculosis

Phase IV trial of Pyrazinamide for Tuberculosis.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Tuberculosis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-10-2024
First CTIS Authorization Date
18-10-2024

Trial design

Randomised, standard of care (standard first-line tb treatment). the protocol describes comparison with standard of care; standard first-line drugs referenced include rif, inh, pza, emb. specific comparator dosing and schedule not specified in the provided record.-controlled Phase IV trial across 2 sites in Sweden.

Randomised
Yes
Comparator
Standard of care (standard first-line TB treatment). The protocol describes comparison with standard of care; standard first-line drugs referenced include RIF, INH, PZA, EMB. Specific comparator dosing and schedule not specified in the provided record.
Target Sample Size
40

Eligibility

Recruits 40 No vulnerable populations selected. Inclusion requires 'Has provided written consent'. No mention of assent or parental consent for minors; no special vulnerable-population consent procedures described..

Vulnerable Population
No vulnerable populations selected. Inclusion requires 'Has provided written consent'. No mention of assent or parental consent for minors; no special vulnerable-population consent procedures described.

Inclusion criteria

  • {"criterion_text":"- Confirmed active pulmonary tuberculosis, through positive culture or positive PCR test for M.tuberculosis-complex.\n- Has provided written consent\n- Assigned for TB-treatment (first-line drugs) but not yet started treatment"}

Exclusion criteria

  • {"criterion_text":"- Has received treatment for active TB in the past 12 months leading up to inclusion in the study\n- 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."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary variable is the area under concentration and time curve (AUC0-24h) for high-dose RIF in a combination regimen with high-dose PZA on day 1 after the first dose and at week 2.","definition_or_measurement_approach":"Measurement of area under the concentration-time curve (AUC0-24h) for high-dose rifampicin in the combination regimen with high-dose pyrazinamide, assessed on day 1 after the first dose and at week 2."}

Recruitment

Planned Sample Size
40
Recruitment Window Months
97
Consent Approach
Written informed consent required from participants ('Has provided written consent'). Subject information and informed consent form documents are listed for the trial; versions include Swedish and English (US) and translated/interpreter versions, indicating multilingual consent materials. No mention of parental consent or assent for minors.

Geography

Total Number Of Sites
2
Total Number Of Participants
40

Sweden

Earliest CTIS Part Ii Submission Date
07-10-2024
Latest Decision Or Authorization Date
18-10-2024
Processing Time Days
11
Number Of Sites
2
Number Of Participants
40

Sites

Site Name
Universitetssjukhuset I
Department Name
Infektionskliniken i Östergötland, Linköpings universitetssjukhus
Principal Investigator Name
Katarina Niward
Principal Investigator Email
katarina.niward@liu.se
Contact Person Name
Katarina Niward
Contact Person Email
katarina.niward@liu.se
Site Name
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Department Name
Infektionskliniken i Östergötland, Vrinnevisjukhuset, Norrköpng
Principal Investigator Name
Katarina Niward
Principal Investigator Email
katarina.niward@liu.se
Contact Person Name
Katarina Niward
Contact Person Email
katarina.niward@liu.se

Sponsor

Primary sponsor

Full Name
Region Oestergoetland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
PYRAZINAMIDE
Active Substance
Pyrazinamide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Approved for the patient category (medicinal products in the study are approved for the patient category)
Maximum Dose
3750 mg per day
Investigational Product Name
RIFAMPICIN
Active Substance
Rifampicin
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Approved for the patient category (medicinal products in the study are approved for the patient category)
Maximum Dose
3300 mg per day
Combination Treatment
Yes

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