NCT03636711

Brief Summary

Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /

  • Pneumoniae
  • Urinary tract infection
  • Cellulitis
  • Meningitis
  • Malaria
  • Febrile neutropenia
  • Febrile acute diarrhea
  • Fever back to the tropics
  • Angina
  • sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

July 9, 2018

Last Update Submit

August 16, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • List of Antibiotic treatment

    Description of the prescribed antibiotic treatment depending of infectious syndrome: name, duration for each treatment during hospitalization Data will be collected in the medical files: * date of introduction of antibiotic treatment * withdrawal dates * stop dates * antibiotic classes

    up to 12 weeks

  • Adverse events

    Description of the cause of non adherence to antibiotic treatment initiates at hospital admission of antibiotherapy: Data will be collected in the medical files of patients: events leading to withdrawal or stop treatment (insufficiency renal, allergic reaction ... etc) date of events aggravation or recovery

    up to 12 weeks

Study Arms (1)

experimental group

• Patient admitted to emergency for infectious syndrome Description of antibiotic protocol, according to a syndromic approach will be performed

Other: antibiotic protocol, according to a syndromic approach

Interventions

Description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols

experimental group

Eligibility Criteria

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

Patients who present a infectious syndrom

You may qualify if:

  • Patient admitted to emergency for infectious syndrome
  • Patient \> 18 years old.
  • Patient who accept to have his medical records reviewed for research.

You may not qualify if:

  • Patient \< 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13005, France

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • EMILIE GARRIDO PRADALIE

    APHM

    STUDY DIRECTOR

Central Study Contacts

PHILIPPE PAROLA, MD

CONTACT

CECILE LAVOUTE, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 17, 2018

Study Start

September 1, 2018

Primary Completion

July 1, 2021

Study Completion

January 1, 2022

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations