Rhino-orbital mucormycosis infection. Mucormycosis, unspecified
Conditions
Interventions
Intervention 1: Intervention group: For patients with mucormycosis included in the intervention group, an initial loading dose of liposomal amphotericin B will be administered for 3 days at a rate of
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Having a probable diagnosis of Mucormycosis based on the treating physician's opinion. Rhino-orbital involvement with mucormycosis Patient consent
Exclusion criteria
Exclusion criteria: Central nervous system involvement by mucormycosis Contraindications to the use of liposomal amphotericin B Not benefiting from the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New organ involvement. Timepoint: Daily, from the start of the intervention until the end of the treatment period or four weeks. Method of measurement: Based on clinical and radiological findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute kidney Injury. Timepoint: Daily, from the start of the intervention until the end of the treatment period or four weeks. Method of measurement: Laboratory Test for measuring Blood Creatinine level: Serum creatinine levels will be measured daily using an automated enzymatic method with validated commercial kits (such as Pars Azmun) and automatic biochemical analyzers (e.g., HITACHI). Daily monitoring and documentation of serum creatinine changes will be performed in both study groups. The incidence of acute kidney injury (AKI) will be defined and assessed based on the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.;Incidence of changes in blood potassium level. Timepoint: Before the intervention begins, and then twice a week for up to four weeks. Method of measurement: Laboratory Test on blood samples: The incidence of changes in serum potassium levels will be assessed. Blood samples are collected before the intervention begins and then twice a week for up to four weeks. Serum potassium levels will be measured biochemically and automatically using the MEDICA Easy Lyte automated electrolyte analyzer. This device uses ISE technology to measure blood electrolytes.;Mortality of patients during the treatment. Timepoint: four weeks after begining of the intervention. Method of measurement: Medical record.;Change in the status of eye involvement. Timepoint: Before the intervention and 4 weeks after the intervention initiation. Method of measurement: Based on clinical and radiological findings.;The extent of the need to add a second antifungal drug to the treatment. Timepoint: Before the intervention and four weeks after the start of the intervention. Method of measurement: Medical record.;CNS involvement. Timepoint: Before the intervention and four weeks after the start of the intervention. Method of measurement: Based on clinical and radiological findings.;Number of debridement procedures required after enrollment in the study. Timepoint: At | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadreza Salehi
Tehran University of Medical Sciences
Outcome results
None listed