Completed

Study of Human Botulism Immunoglobulin in Infants With Botulism

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What is being tested

botulism immune globulin

Drug
Who is being recruted

Bacterial Infections and Mycoses+16

+ Foodborne Diseases

+ Infections

Until 1 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 1998
See protocol details

Summary

Principal SponsorCalifornia Department of Health Services
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1998

Actual date on which the first participant was enrolled.

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

NCT00004401
Principal SponsorCalifornia Department of Health Services
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 1 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesFoodborne DiseasesInfectionsNervous System DiseasesNeuromuscular DiseasesPathologic ProcessesPoisoningPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsNeurotoxicity SyndromesNeuromuscular Junction DiseasesDisease AttributesChemically-Induced DisordersBacterial InfectionsBotulismClostridium InfectionsCommunicable DiseasesImmune System DiseasesRare Diseases

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

California Department of Health Services

Berkeley, United StatesOpen California Department of Health Services in Google Maps
CompletedOne Study Center