A prospective, open-label, randomisation-controlled trial of combination antifungal therapy (Liposomal Amphotericin B and Posaconazole) vs single antifungal (Liposomal Amphotericin B) for initial treatment in Mucormycosis (ComPLiMenT Trial) - ComPLiMenT Trial

AIIMS Department of Medicine0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•All patients aged 18 years or more, newly diagnosed probable (clinical and radiological) or proven invasive mucormycosis will be included.

•1 Patients not willing to consent.
•2 Patients with more than 5 days of primary antifungal therapy
•3 Patients unable to receive enteral medications.
•4 Co-existing conditions precluding the use of both Amphotericin B or Posaconazole
•a Liposomal Amphotericin B â?? history of hypersensitivity
•b Posaconazole â?? H/o hypersensitivity (other azoles), Concurrent drugs (Sirolimus: can result in sirolimus toxicity; CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of Torsades de Pointes; HMG-CoA Reductase Inhibitors Primarily Metabolized Through CYP3A4: can lead to rhabdomyolysis, Ergot alkaloids: can result in ergotism drug interactions); Transaminitis ( AST or ALT >5 times ULN)
•5 Patients who are critically ill/ hemodynamic instability
•6 Patients with active moderate and severe COVID19 illness at the time of recruitment
•7 Breastfeeding/ pregnancy
•8 Patient enrolled in other ongoing prospective drug trials for IM

发起方

AIIMS Department of Medicine