Role of combination antifungal therapy (Liposomal Amphotericin B and Posaconazole) in Mucormycosis
- Conditions
- Health Condition 1: B46- Zygomycosis
- Registration Number
- CTRI/2021/07/034907
- Lead Sponsor
- AIIMS Department of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete or partial response at week 3Timepoint: 3 weeks
- Secondary Outcome Measures
Name Time Method 1.Complete response at week 6 and week 12 <br/ ><br>Timepoint: 6 weeks, 12 weeks;3.Reduction in all-cause mortalityTimepoint: 12 months; <br/ ><br>2.Increased survival at week 12, 6 months and 12 months. <br/ ><br> <br/ ><br>Timepoint: 3, 6 and 12 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.