Health Condition 1: B46- Zygomycosis
Conditions
Interventions
Intervention1: Combination of Liposomal Amphotericin B plus Tablet Posaconazole: In intervention arm, study particiants will receive combination of Liposomal Amphotericin B plus Tablet Posaconazole
Do
Sponsors
AIIMS Department of Medicine
Eligibility
Inclusion criteria
Inclusion criteria: All patients aged 18 years or more, newly diagnosed probable (clinical and radiological) or proven invasive mucormycosis will be included.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete or partial response at week 3Timepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Complete response at week 6 and week 12 Timepoint: 6 weeks, 12 weeks;3.Reduction in all-cause mortalityTimepoint: 12 months; 2.Increased survival at week 12, 6 months and 12 months. Timepoint: 3, 6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Rohit Kumar
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed