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NCT00004401 · ClinicalTrials.gov registry record · NA

Study of Human Botulism Immunoglobulin in Infants With Botulism

A NA study of Botulism and Infant Botulism, sponsored by California Department of Health Services.

Completed
Registry status
NA
Development phase
120
Enrollment target
1
Study location

NCT00004401 is a NA study of Botulism and Infant Botulism that has completed, run by California Department of Health Services. The registered enrollment target is 120 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT00004401, a NA study of Botulism and Infant Botulism, has completed, sponsored by California Department of Health Services.

COMPLETED
Registry status
NA
Development phase
120 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG botulism immune globulin

Study Locations (1)

California

  • California Department of Health Services - Berkeley

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 1998-01
Est. Completion 1998-06
Phase NA

What the Registry Record Tells You About NCT00004401

The ClinicalTrials.gov registry entry for NCT00004401 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is California Department of Health Services, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Botulism appearing as the primary indexed condition, and to 1 intervention - of which botulism immune globulin is the first listed.

NCT00004401 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00004401 about?

NCT00004401 is a clinical study titled "Study of Human Botulism Immunoglobulin in Infants With Botulism". 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 (res...

What is the current status of trial NCT00004401?

This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 1998-01. Estimated completion is 1998-06.

What conditions does trial NCT00004401 study?

This clinical trial studies the following conditions: Botulism, Infant Botulism.

What interventions are being tested in trial NCT00004401?

The interventions under investigation include: botulism immune globulin (DRUG).

Who is sponsoring clinical trial NCT00004401?

This trial is sponsored by California Department of Health Services, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00004401 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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