Urea in Blood; HighNCT04020406
Antibacterial Activity of Urea Against Ocular Bacteria
An observational study of Urea in Blood; High, run by Assiut University at 1 site in Egypt.
Trial summary
Antibacterial properties of urea was tested against 35 isolates from ocular infections. Read more about this study
- Who is it for?
- Ages 5 months to 65 years
- Conditions the study is for
- Urea in Blood; High
- What is being tested?
- Antibacterial Activity
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Nov 2018
- 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 5 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: individuals with any ocular infection
Who may be able to join
- ocular infection
Who cannot join
- Local antibiotics treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Evaluation of Antibacterial Activity of Urea Solution Against Ocular Bacterial Isolates
Antibacterial properties of urea was tested against 35 isolates from ocular infections.
Read the detailed description
In vitro susceptibility testing was performed with commercially available antibiotic discs, homemade urea discs saturated with urea solution at a concentration of 96 mmol. The weight of urea in one drop = 0.37 mg, in one ml = 10.34 mg (5 microliter/ disc) discs and combined discs (antibiotic discs to which urea solution was added). Combined discs provided better in vitro susceptibility results than antibiotics alone.
Scanning electron micrographs of bacterial isolates incubated overnight with urea solution showed marked disruption of bacterial aggregative patterns and irregularities of their cell walls.
Western blotting showed marked reduction in total proteins in bacterial isolates incubated overnight with urea solution. These findings may explain the possible mechanisms for antibacterial activity of urea solution as a result of protein denaturation.
- Conditions
- Urea in Blood; High
- Being tested
- Antibacterial Activity
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibacterial ActivityBiological
Antibacterial Activity of Urea Solution against Ocular Bacterial Isolates
| Study group | Role | What they receive |
|---|---|---|
| Antibacterial Activity of Urea | Activity of Urea Solution against Ocular Bacterial Isolates Receives: Biological: Antibacterial Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibacterial effect of Urea Solution against Ocular Bacterial
Samples were both inoculated on Muller Agar (Sigma-Aldrich) plates and directly examined under the microscope using Gram stained smears. Inoculated plates were incubated at 37oC for 48 hrs.
Gram negative isolates were sub-cultured on MacConkey's, Eosin Methelyene Blue (EMB) and Cystine Lactose Electrolyte Deficient (CLED) agar plates (Sigma-Aldrich). Gram positive isolates were sub-cultured on Mannitol Salt agar plates (Sigma-Aldrich).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Nov 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urea in Blood; HighStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Lotfy Fahmy, Assiut University
- Investigators
- Hassan 58 Lotfy, Professor, Principal investigator, Assiut T
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020406
- Sponsor's protocol ID
- 2323297
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Evaluation of Antibacterial Activity of Urea Solution Against Ocular Bacterial Isolates
- ClinicalTrials.gov ID
- NCT04020406
- Acronym / sponsor ID
- 2323297
- Conditions
- Urea in Blood; High
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 16 Jul 2019 (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.
Antibacterial properties of urea was tested against 35 isolates from ocular infections.
Detailed description
In vitro susceptibility testing was performed with commercially available antibiotic discs, homemade urea discs saturated with urea solution at a concentration of 96 mmol. The weight of urea in one drop = 0.37 mg, in one ml = 10.34 mg (5 microliter/ disc) discs and combined discs (antibiotic discs to which urea solution was added). Combined discs provided better in vitro susceptibility results than antibiotics alone.
Scanning electron micrographs of bacterial isolates incubated overnight with urea solution showed marked disruption of bacterial aggregative patterns and irregularities of their cell walls.
Western blotting showed marked reduction in total proteins in bacterial isolates incubated overnight with urea solution. These findings may explain the possible mechanisms for antibacterial activity of urea solution as a result of protein denaturation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antibacterial Activity of Urea | – | Biological: Antibacterial ActivityActivity of Urea Solution against Ocular Bacterial Isolates |
Who may qualify
- Ages
- 5 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- individuals with any ocular infection
Key inclusion criteria (1 listed)
- ocular infection
Key exclusion criteria (1 listed)
- Local antibiotics treatment
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 |
|---|---|---|
| Antibacterial ActivityAntibacterial Activity of Urea Solution against Ocular Bacterial Isolates | Biological | Antibacterial Activity of Urea |
Primary outcome
Antibacterial effect of Urea Solution against Ocular Bacterial
Time frame: 6 month
Samples were both inoculated on Muller Agar (Sigma-Aldrich) plates and directly examined under the microscope using Gram stained smears. Inoculated plates were incubated at 37oC for 48 hrs. Gram negative isolates were sub-cultured on MacConkey's, Eosin Methelyene Blue (EMB) and Cystine Lactose Electrolyte Deficient (CLED) agar plates (Sigma-Aldrich). Gram positive isolates were sub-cultured on Mannitol Salt agar plates (Sigma-Aldrich).
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 16 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Hassan 58 Lotfy, Professor principal investigator
Assiut T
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 Urea in Blood; High, 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 16 Jul 2019. 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?
Antibacterial effect of Urea Solution against Ocular Bacterial (time frame: 6 month). 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 16 Jul 2019.