Invasive Infections in Children With Hemoglobinopathies | NCT00456443

Studies
Invasive Infections in Children With Hemoglobinopathies

NCT00456443

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Apr 5, 2007Estimated

Enrollment

200

Phase

Not provided

Conditions

Thalassemia
Sickle Cell Anemia

Interventions

Historical records

Countries

Israel

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

Apr 2007

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

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 5, 2007Estimated

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

Apr 4, 2007

Last Update Posted Date

Apr 5, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. The purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.

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

Not provided

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

200

Name	Type	Description	Arm Group Labels	Other Names
Historical records	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients treated in the Pediatric Hematology Unit.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ariel Koren, MD	Pediatric Hematology Unit, Ha'Emek Medical Center	Study Director
Waheeb Sakran, MD	Pediatric Dpt B - Ha'Emek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D013789	Thalassemia
D000755	Anemia, Sickle Cell
D007239	Infections
D011014	Pneumonia

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided