PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE) (NCT04550832) | Clinical Trial Compass
CompletedPhase 2
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
South Africa, Tanzania76 participantsStarted 2021-10-28
Plain-language summary
This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose Bedaquiline, Delamanid and Moxifloxacin alone
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provide written, informed consent prior to all trial-related procedures including HIV testing.
✓. Male or female, aged between 18 and 65 years, inclusive.
✓. Body weight between 40 and 90 kg, inclusive.
✓. Newly diagnosed, previously untreated, drug susceptible pulmonary TB: presence of MTB complex and rapid molecular tests result confirming susceptibility to RIF and INH such as GeneXpert and/or HAIN MTBDR plus.
✓. A chest X-ray (no older than 2 weeks) which, in the opinion of the Investigator, is consistent with TB.
✓. Sputum positive on microscopy from concentrated sputum for acid-fast bacilli on at least one sputum sample (at least 1+ on the IUATLD/WHO scale).
✓. The participant is willing to forgo consumption of foods high in tyramine for the period of taking study medication (See Appendix, section 20.2, page 92).
✓. The participant is either unable to conceive/father children AND/OR his/her partner is unable to conceive/father children AND/OR they will consent to be using effective methods of contraception when engaging in heterosexual intercourse, as defined below:
Exclusion criteria
✕. Circumstances that raise doubt about free, unconstrained consent to study participation (e.g. prisoner or mentally handicapped person)
✕. Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.
What they're measuring
1
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Timeframe: week0 - week52
2
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_AUC0-24
Timeframe: Week 0 - Week 16
3
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmax
Timeframe: Week 0 - Week 16
4
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmin
. Poor social condition which would make it unlikely that the patient would be able to complete follow-up
✕. The patient is pregnant or breast-feeding.
✕. The patient is infected with HIV with a CD4 count \<220 cells/mm3. If \>220 cells/mm3, patients will be included only if any of the following is applicable:
✕. The patient has a known intolerance to any of the study drugs or concomitant disorders or conditions for which study drugs or standard TB treatment are contraindicated
✕. The patient has a history of, or current evidence of clinically relevant cardiovascular metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or any other condition that will influence treatment response, study adherence or survival in the judgement of the investigator, especially:
✕. Neuropathy, or significant psychiatric disorder like depression or schizophrenia; especially if treatment for those has ever been required or is anticipated to be required