Intravenous Pertussis Immune Globulin in Patients With Se... | NCT00004422

Studies
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

NCT00004422

Sponsor

IWK Health Centre

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

174

Phase

Phase 3

Conditions

Pertussis
Whooping Cough

Interventions

immune globulin

Countries

Not provided

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

Jun 2000

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

Aug 1997

Primary Completion Date

Not provided

Completion Date

Sep 2002

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

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

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Description Module

Brief Summary

OBJECTIVES:

Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive an infusion of either pertussis immune globulin or placebo (0.9% saline).

Patients are followed every 2 weeks for up to 6 months.

Completion date provided represents the completion date of the grant per OOPD records

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

174

Name	Type	Description	Arm Group Labels	Other Names
immune globulin	Drug

Eligibility Module

Eligibility Criteria

Documented infection with Bordetella pertussis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Scott A. Halperin	IWK Health Centre	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D014917	Whooping Cough
D001424	Bacterial Infections
D007154	Immune System Diseases
D003141	Communicable Diseases
D035583	Rare Diseases

Ancestor Terms

ID	Term
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007136	Immunoglobulins

Ancestor Terms

ID	Term
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
IWK-FDR001044
P9701