Status:
UNKNOWN
PRACTECAL-PKPD Sub Study
Lead Sponsor:
Medecins Sans Frontieres, Netherlands
Collaborating Sponsors:
London School of Hygiene and Tropical Medicine
Global Alliance for TB Drug Development
Conditions:
Multi-drug Resistant Tuberculosis
Extensively Drug-Resistant Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial ...
Detailed Description
PRACTECAL-PKPD is a sub-study of the main TB-PRACTECAL phase II-III trial for the treatment of biologically confirmed pulmonary multi drug or extensively drug-resistant TB (M/XDR-TB). TB-PRACTECAL is ...
Eligibility Criteria
Inclusion
- Main study inclusion criteria\*:
- Patients eligible for inclusion in the trial must fulfil all of the following criteria:
- Male or female subjects aged 15 years of age or above, regardless of HIV status;
- Microbiological test (molecular or phenotypic) confirming presence of M. tuberculosis;
- Resistant to at least rifampicin by either molecular or phenotypic drug susceptibility test;
- Completed informed consent form (ICF);
- Main study exclusion criteria:
- Known allergies, hypersensitivity, or intolerance to any of the study drugs;
- Pregnant or breast-feeding; or unwilling to use appropriate contraceptive measures
- Liver enzymes \>3 times the upper limit of normal;
- Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe;
- Taking any medications contraindicated with the medicines in the trial; QTcF \> 450ms;
- One or more risk factors for QT prolongation (excluding age and gender) or other uncorrected risk factors for TdP;
- History of cardiac disease, syncopal episodes, symptomatic or asymptomatic arrhythmias (with the exception of sinus arrhythmia);
- Any baseline biochemical laboratory value consistent with Grade 4 toxicity.
- Moribund
- Known resistance to bedaquiline, pretomanid, delamanid or linezolid.
- Prior use of bedaquiline and/or pretomanid and/or linezolid and/or delamanid for one or more months.
- Patients not eligible to start a new course of MDR-TB/XDR-TB treatment according to local protocol, including but not limited to:
- currently on MDR-TB treatment for more than 2 weeks (and not failing)
- unstable address
- loss to follow-up in previous treatment with no change in circumstance and motivation.
- Tuberculous meningoencephalitis, brain abscesses, osteomyelitis or arthritis.
- \*PKPD inclusion/exclusion:
- Adult patients (aged 18 years or above) recruited into the investigational arms of the TB-PRACTECAL trial in the approved sites.
- Willing to sign the sub-study informed consent form after agreeing to the additional blood draws.
Exclusion
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04081077
Start Date
August 6 2019
End Date
September 30 2022
Last Update
May 14 2021
Active Locations (5)
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1
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital
Minsk, Belarus
2
Helen Jospeh Hospital
Johannesburg, Gauteng, South Africa, 2092
3
THINK Clinical Trial Unit, Hillcrest
Durban, KwaZulu-Natal, South Africa, 3650
4
King DinuZulu Hospital
Durban, KwaZulu-Natal, South Africa, 4091