Study of Human Botulism Immunoglobulin in Infants With Botulism - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

January 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004401 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Human Botulism Immunoglobulin in Infants With Botulism

Official Title ^ICMJE

Brief Summary

OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis).

II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence of complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.

Detailed Description

PROTOCOL OUTLINE: This is an open label, multicenter study. Patients should begin therapy within 72 hours of hospital admission, but may receive human botulism immunoglobulin (BIG) in certain circumstances after 72 hours. Patients receive (BIG) IV. Patients are monitored for side effects, disease severity, complications, and length of hospital stay.

Patients are followed at 2 weeks after treatment, then every 4 weeks for 6 months.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Infant Botulism
Botulism

Intervention ^ICMJE

Drug: botulism immune globulin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Clinical diagnosis of infant botulism in previously healthy infant
Bulbar palsies
Constipated Lethargy
Diminished head control
Poor feeding
Generalized weakness and hypotonia
Weak cry
Afebrile (unless secondary infection present)
Subacute to acute onset
Normal electrolytes
Any patient eligible provided no treatment available for life-threatening condition

Gender

Both

Ages

up to 1 Year

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004401

Responsible Party

Study ID Numbers ^ICMJE

199/13253, CDHS-FDU000476

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

California Department of Health Services

Investigators ^ICMJE

Study Chair:

Stephen S. Arnon

California Department of Health Services

Information Provided By

FDA Office of Orphan Products Development

Verification Date

March 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP