Clinical Presentations, Microbiology, Antibiotic Resistan... | NCT04395586

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to COVID-19 panemic

Expanded Access Info

Start Date

Jul 1, 2020Estimated

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

May 15, 2020

First Submission Date that Met QC Criteria

May 15, 2020

First Posted Date

May 20, 2020Actual

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

Dec 11, 2021

Last Update Posted Date

Jan 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdullah M. Algarni, Family medicine senior registrar, Aseer Central HospitalPrincipal Investigator

Lead Sponsor

Aseer Central HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The characteristics of patients as well as microbiologic profile of culture-proven infection will be studies in conjunction with clinical outcome within 28-days

Detailed Description

Not provided

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

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Culture-proven infected patients			Other: Culture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Culture	Other	Culture	Culture-proven infected patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	All-cause and disease specific mortality	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any individual aged ≥13 year old requested for him/her bacterial/fungal culture.
Able to provide a written informed consent.

Exclusion Criteria:

Age <13 years old.
Unable/unwilling to provide a written informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Any individual aged ≥13 year old requested for him/her bacterial/fungal culture.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdullah M Algarni, MBBS	Aseer Central Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D066298	In Vitro Techniques
D008919	Investigative Techniques