Covid19NCT04479982
Microbial Infection and AMR in Hospitalized Patients With Covid 19
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
Trial summary
To detect microbial infection and AMR associated with COVID 19 infection. To correlate risk factors of COVID 19 patients with microbial infections and their effects on disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients with covid 19
Who may be able to join
- Patients with Covid infection
Who cannot join
- Patients without covid 19
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut hopital
Asyut, 6001
shimaa faheem, master
About this study
Official title: Microbial Infections and Antimicrobial Resistance (AMR) Patterns Associated With Hospitalized Patients With 2019 Novel Coronavirus Disease (COVID 19)
To detect microbial infection and AMR associated with COVID 19 infection.
To correlate risk factors of COVID 19 patients with microbial infections and their effects on disease.
Read the detailed description
The most common type of infection among ICU patients was bacterial or fungal pneumonia; bloodstream and urinary tract infections were also noted. Organisms cultured from patients included pandrug-resistant Acinetobacter baumannii, Klebsiella pneumoniae carbapenemase-producing K. pneumoniae, extended-spectrum β-lactamase (ESBL)- producing K. pneumoniae, ESBL-producing Pseudomonas aeruginosa, Enterobacter cloacae, Serratia marcescens, Aspergillus fumigatus, Aspergillus flavus, Candida albicans, and Candida glabrata .
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial infections and antimicrobial resistance (AMR) patterns associated with hospitalized patients with 2019 novel coronavirus disease (COVID 19)
The correlation between microbial infection and COVID 19 infection and their effect on prognosis and disease outcome.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start24 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALShymaa faheem solyman ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479982
- Sponsor's protocol ID
- Microbial infection with covid
- Status last verified
- Sep 2020
- First submitted
- 17 Jul 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Infections and Antimicrobial Resistance (AMR) Patterns Associated With Hospitalized Patients With 2019 Novel Coronavirus Disease (COVID 19)
- ClinicalTrials.gov ID
- NCT04479982
- Acronym / sponsor ID
- Microbial infection with covid
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To detect microbial infection and AMR associated with COVID 19 infection.
To correlate risk factors of COVID 19 patients with microbial infections and their effects on disease.
Detailed description
The most common type of infection among ICU patients was bacterial or fungal pneumonia; bloodstream and urinary tract infections were also noted. Organisms cultured from patients included pandrug-resistant Acinetobacter baumannii, Klebsiella pneumoniae carbapenemase-producing K. pneumoniae, extended-spectrum β-lactamase (ESBL)- producing K. pneumoniae, ESBL-producing Pseudomonas aeruginosa, Enterobacter cloacae, Serratia marcescens, Aspergillus fumigatus, Aspergillus flavus, Candida albicans, and Candida glabrata .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients with covid 19
Key inclusion criteria (1 listed)
- Patients with Covid infection
Key exclusion criteria (1 listed)
- Patients without covid 19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbial infections and antimicrobial resistance (AMR) patterns associated with hospitalized patients with 2019 novel coronavirus disease (COVID 19)
Time frame: baseline
The correlation between microbial infection and COVID 19 infection and their effect on prognosis and disease outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshymaa Ali, PHD (01090581638, shimaafahim25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial infections and antimicrobial resistance (AMR) patterns associated with hospitalized patients with 2019 novel coronavirus disease (COVID 19) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.