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

2024-518772-32-00 Protocol HIGH-SHORT RP Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol HIGH-SHORT RP

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 40
Countries 1
Sites 2

Tuberculosis

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.

Key facts

Sponsor
Region Oestergoetland
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial)
2024-10-18
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518772-32-00
EudraCT number
2019-003721-25

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Dose response, Safety

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.

Conditions and MedDRA coding

Tuberculosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Confirmed active pulmonary tuberculosis, through positive culture or positive PCR test for M.tuberculosis-complex.
  2. Has provided written consent
  3. Assigned for TB-treatment (first-line drugs) but not yet started treatment

Exclusion criteria 2

  1. Has received treatment for active TB in the past 12 months leading up to inclusion in the study
  2. 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 and secondary outcome measures (English text)

Primary endpoints 1

  1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Pyrazinamide

SCP134380 · ATC

Active substance
Pyrazinamide
Route of administration
ORAL
Max daily dose
3750 mg milligram(s)
Max total dose
450000 mg milligram(s)
Max treatment duration
4 Month(s)
Authorisation status
Authorised
ATC code
J04AK01 — PYRAZINAMIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rifampicin

SCP135738 · ATC

Active substance
Rifampicin
Substance synonyms
RIFAMPIN
Route of administration
ORAL
Max daily dose
3300 mg milligram(s)
Max total dose
396000 mg milligram(s)
Max treatment duration
4 Month(s)
Authorisation status
Authorised
ATC code
J04AB02 — RIFAMPICIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oestergoetland

12 Total trials 8 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Region Oestergoetland
Address
Universitetssjukhuset I
City
Linkoping
Postcode
58185
Country
Sweden

Scientific contact point

Organisation
Region Oestergoetland
Contact name
Katarina Niward

Public contact point

Organisation
Region Oestergoetland
Contact name
Katarina Niward

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Authorised, recruitment pending 40 2
Rest of world — 0 —

Investigational sites

Sweden

2 sites · Authorised, recruitment pending
Region Oestergoetland
Infektionskliniken i Östergötland, Linköpings universitetssjukhus, Universitetssjukhuset I, 58185, Linkoping
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Infektionskliniken i Östergötland, Vrinnevisjukhuset, Norrköpng, S Borg, Gamla Ovagen 25, Norrkoping

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Studieprotokoll HSRP 3
Recruitment arrangements (for publication) Blankt dokument_High-short_RP 1
Subject information and informed consent form (for publication) 5a Patientinformation_HighShort_RP_US_20200712_clean_FINAL 1
Subject information and informed consent form (for publication) 5a Patientinformation_HighShort_RP_US_TOLK_20200712_clean_FINAL 1
Subject information and informed consent form (for publication) 5b Patientinformation_HighShort_RP_20200712_ovriga site_clean_FINAL 1
Subject information and informed consent form (for publication) 5b Patientinformation_HighShort_RP_20200712_ovriga site_TOLK_clean_FINAL 1
Subject information and informed consent form (for publication) 6a 2020-02-12 Dagbok for High-short RP_interventionsgruppen 1
Subject information and informed consent form (for publication) 6b 2020-02-12 Dagbok for High-short RP_kontrollgruppen 1
Synopsis of the protocol (for publication) Synopsis 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-08 Sweden Acceptable
2024-10-17
 2024-10-18

Related clinical trials