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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: Completed NA study of Botulism and Infant Botulism, sponsored by California Department of Health Services.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 1998-01 |
| Est. Completion | 1998-06 |
| Phase | NA |
What the finished NCT00004401 record still lists
NCT00004401 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00004401's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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