- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06267326
World Health Organization (WHO) , COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
February 16, 2024 updated by: Nasser Institute For Research and Treatment
Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Omar Elmonofy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- all patients with mucormycosis post covid 19
Exclusion Criteria:
- The patient not suffered from covid 19
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years
Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids.
patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients.
Hyperbaric oxygen was used in five patients post-surgically.
all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal.
The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors
|
resection of dead bone
Other Names:
|
|
Experimental: Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17
Twenty-one (60%) males and fourteen (40%) females, mean age was 44.17 years eighteen patients presented with COVID 19 and seventeen patients presented to our hospital post healing with history of using large doses of systemic corticosteroids.
patients were managed by aggressive surgical debridement, antifungal drugs Amphotericin B and adjunctive treatment like local irrigation with amphotericin B and hyperbaric oxygen according to systemic conditions of patients.
Hyperbaric oxygen was used in five patients post-surgically.
all investigations were done with mean values of blood glucose level, hemoglobin and WBC were noticeably abnormal.
The degree of severity, length of stay, and mortality rate were significantly correlated with the severity of systemic predisposing factors
|
resection of dead bone
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
35 patients suffering from mucormycosis infection post covid 19
Time Frame: 2 years
|
Ratio Scale.
Visual Analog Score for pain Ratio Scale.
Ratio Scale.
ratio scale
|
2 years
|
|
25 patients were cured with comorbidity and 10 pateints died
Time Frame: 2 years
|
ordinal scale Visual Analog Score for pain
|
2 years
|
|
pain
Time Frame: two years
|
Visual Analog Score for pain
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Score for pain
Time Frame: 2years
|
pain
|
2years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2021
Primary Completion (Actual)
June 12, 2022
Study Completion (Actual)
August 21, 2023
Study Registration Dates
First Submitted
January 20, 2024
First Submitted That Met QC Criteria
February 16, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nasser institute
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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