AspergillosisNCT04431804
THYME AND CARVACROLL Nanoparticle Effect on Fungi
An observational study of Aspergillosis, run by Assiut University at 1 site in Egypt.
Trial summary
Invasive Aspergillosis (IA) has increasingly been recognized as an emerging disease of non-neutropenic patients and in patients admitted to the ICU, even in the absence of an apparent predisposing immune-deficiency, with incidence ranges from 0.3% to 5.8% with an overall mortality rate exceeding 80%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aspergillosis
- What is being tested?
- silver nanoparticle
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2020to 30 Sep 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
- Child, Adult, Older adult
Study population: intensive care patients
Who may be able to join
- intensive care patients
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thyme and Carvacroll Nanoparticles on Aspergillus Fumigatus Isolate From Intensive Care Patients
Invasive Aspergillosis (IA) has increasingly been recognized as an emerging disease of non-neutropenic patients and in patients admitted to the ICU, even in the absence of an apparent predisposing immune-deficiency, with incidence ranges from 0.3% to 5.8% with an overall mortality rate exceeding 80%.
- Conditions
- Aspergillosis
- Being tested
- silver nanoparticle
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver nanoparticleOther
fungicidal effect of silver nanoparticles on aspergillus isolates
What is being measured
The primary outcome is the main question the study is designed to answer.
fungicidal effect of silver nanoparticles on aspergillus fumigatus
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start11 Jun 2020
- Primary completion20 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431804
- Sponsor's protocol ID
- wwww
- Status last verified
- Nov 2020
- First submitted
- 11 Jun 2020
- Last updated
- 5 Nov 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thyme and Carvacroll Nanoparticles on Aspergillus Fumigatus Isolate From Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04431804
- Acronym / sponsor ID
- wwww
- Conditions
- Aspergillosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Jun 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.
Invasive Aspergillosis (IA) has increasingly been recognized as an emerging disease of non-neutropenic patients and in patients admitted to the ICU, even in the absence of an apparent predisposing immune-deficiency, with incidence ranges from 0.3% to 5.8% with an overall mortality rate exceeding 80%.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- intensive care patients
Key inclusion criteria (1 listed)
- intensive care patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silver nanoparticlefungicidal effect of silver nanoparticles on aspergillus isolates | Other | – |
Primary outcome
fungicidal effect of silver nanoparticles on aspergillus fumigatus
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aspergillosis, 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: finished, as of the sponsor's last update on 5 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fungicidal effect of silver nanoparticles on aspergillus fumigatus (time frame: 24 hours). 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 5 Nov 2020.