A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis.
Alexa DierigM HoelscherS SchultzL HoffmannA Jarchow-MacDonaldE M SvenssonL Te BrakeR AarnoutseM BoereeT D McHughL M WildnerX GongPpj PhillipsL T MinjaN NtinginyaS MpagamaA LiyoyoR S WallisM SebeF A MhimbiraB MbeyaM RassoolL GeiterY L ChoN HeinrichPublished in: Trials (2023)
DECODE was registered in ClinicalTrials.gov before recruitment start on 22 October 2021 (NCT04550832).
Keyphrases
- pulmonary tuberculosis
- open label
- phase iii
- newly diagnosed
- phase ii
- mycobacterium tuberculosis
- study protocol
- clinical trial
- drug resistant
- multidrug resistant
- phase ii study
- placebo controlled
- double blind
- randomized controlled trial
- squamous cell carcinoma
- emergency department
- adverse drug
- electronic health record