NCT00004401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 1998

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2000

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Infant BotulismBotulism

Keywords

bacterial infectionclostridium infectionimmunologic disorders and infectious disordersinfant botulismrare disease

Interventions

botulism immune globulinDRUG

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

California Department of Health Services

Berkeley, California, 94704-1011, United States

Location

MeSH Terms

Conditions

BotulismBacterial InfectionsClostridium InfectionsImmune System DiseasesCommunicable DiseasesRare Diseases

Interventions

botulism immune globulin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial Infections and MycosesInfectionsNeuromuscular Junction DiseasesNeuromuscular DiseasesNervous System DiseasesNeurotoxicity SyndromesFoodborne DiseasesPoisoningChemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen S. Arnon

    California Department of Health Services

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

January 1, 1998

Study Completion

June 1, 1998

Last Updated

March 25, 2015

Record last verified: 2000-03

Locations

US(1)