Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

Pertussis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004422
• Other study ID #: 199/13322
• Secondary ID: IWK-FDR001044P97
• Status: Completed
• Phase: Phase 3
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: August 1997
• Est. completion date: September 2002

Study information

• Verified date: June 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years
• Eligibility: - Documented infection with Bordetella pertussis

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

Drug:
• immune globulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre