Multicenter Study of Tetanus Patients in Fujian Province... | NCT04165928

Studies
Multicenter Study of Tetanus Patients in Fujian Province of China

NCT04165928

Sponsor

Fujian Provincial Hospital

Status

Completed

Last Update Posted

Nov 18, 2019Actual

Enrollment

95Actual

Phase

Not provided

Conditions

Tetanus

Interventions

Not provided

Countries

China

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

Nov 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

Jul 1, 2018Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Oct 31, 2019Actual

First Submitted Date

Nov 13, 2019

First Submission Date that Met QC Criteria

Nov 14, 2019

First Posted Date

Nov 18, 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

Nov 14, 2019

Last Update Posted Date

Nov 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiuling Shang, Deputy Director of the Physician, Fujian Provincial HospitalPrincipal Investigator

Lead Sponsor

Fujian Provincial HospitalOTHER

Collaborators

Not provided

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

Background: Tetanus is a life-threatening disease in developing countries, and accompanied by a high mortality rate. China is the world's largest developing country, and Fujian Province is a typical coastal province in China with a relatively developed economy. Therefore, the purpose of this study was to investigate the epidemiology, incidence and management of tetanus in Fujian Province and to understand the current treatment and prognosis of tetanus patients in China.

Methods: This was a retrospective multicenter observational study of patients who presented with a clinical diagnosis of tetanus at 5 general hospitals in Fujian. Data was analyzed using computer software system.

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

No data available

No data is available for this block.

Enrollment

95Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Outcomes of the tetanus patients	The survival data of tetanus patients.	2008-01-01~2018-10-31

Secondary Outcomes

Measure	Description	Time Frame
The hospitalization time.	The total length of hospitalization and the length of stay in the ICU.	2008-01-01~2018-10-31

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Provincial Hospital		Fuzhou	Fujian	350000	China

Condition Browse Module

MeSH Terms

ID	Term
D013742	Tetanus

Ancestor Terms

ID	Term
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided