Antibacterial Activity of Urea Against Ocular Bacteria | NCT04020406

Studies
Antibacterial Activity of Urea Against Ocular Bacteria

NCT04020406

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jul 16, 2019Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Urea in Blood; High

Interventions

Antibacterial Activity

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Nov 1, 2018Actual

Completion Date

Nov 1, 2018Actual

First Submitted Date

Jul 7, 2019

First Submission Date that Met QC Criteria

Jul 11, 2019

First Posted Date

Jul 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2019

Last Update Posted Date

Jul 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antibacterial Activity of Urea		Activity of Urea Solution against Ocular Bacterial Isolates	Biological: Antibacterial Activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibacterial Activity	Biological	Antibacterial Activity of Urea Solution against Ocular Bacterial Isolates	Antibacterial Activity of Urea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ocular infection

Exclusion Criteria:

Local antibiotics treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Months

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

individuals with any ocular infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hassan 58 Lotfy, Professor	Assiut T	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hassan Lotfy Fahmy		Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014511	Uremia

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

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