NCT05606627

Brief Summary

Correlation between antibiotic resistance and incidence of sepsis in community acquired pneumonia in RICU patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

October 22, 2022

Last Update Submit

November 3, 2022

Conditions

Community-acquired PneumoniaAntibiotic ResistanceSepsis

Outcome Measures

Primary Outcomes (1)

  • 1.Define antibiotic resistant organisms 2.Assess correlation between antibiotic resistance and incidence of sepsis in CAP patiants 3. Assess incidence of sepsis in CAP patiants using SOFA score.

    October 2022/ April 2024

Secondary Outcomes (1)

  • 1.Decrease MDR phenomenon 2.improving mortality and morbidity of patients with sever CAP in ICU.

    October 2022/April 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to RICU with sever community acquired pneumonia.

You may qualify if:

  • \- 1. Patients above 18 yrs. old. 2. Patients with sever community acquired bacterial pneumonia confirmed by clinical symptoms (CURB-65 scores \>= 4) and culture.
  • Informed consent to participate in the study is provided.

You may not qualify if:

  • \- 1. Patients below 18 yrs. old. 2. Patient don't meet the criteria of community acquired bacterial pneumonia (viral, fungal, chemical,…etc.).
  • \. Patients with comorbid respiratory diseases. 4. Patients with Hospital acquired pneumonia. 5. Patients receiving empirical antibiotics. 6. Patients receiving anti-TB drugs, systemic steroids or chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Community-Acquired PneumoniaSepsis

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Aya Abdelrhman Kotb

CONTACT

01069555261ayaabdelrhman409@gmail.com

Atef Farouk El-karn

CONTACT

01006474200Afaroukeg@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

October 22, 2022

First Posted

November 7, 2022

Study Start

December 1, 2022

Primary Completion

October 1, 2023

Study Completion

April 1, 2024

Last Updated

November 7, 2022

Record last verified: 2022-11