Infant BotulismNCT00004401
Study of Human Botulism Immunoglobulin in Infants With Botulism
A study testing botulism immune globulin in people with Infant Botulism and Botulism, run by California Department of Health Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infant Botulism, Botulism
- What is being tested?
- botulism immune globulin
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Jun 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Department of Health Services
Berkeley, California, 94704-1011
About this study
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.
Read the 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.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Infant Botulism, Botulism
- Being tested
- botulism immune globulin
- Keywords
- bacterial infection, clostridium infection, immunologic disorders and infectious disorders, infant botulism, rare disease
- Medical subject headings
- Botulism, Bacterial Infections, Clostridium Infections, Immune System Diseases, Communicable Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulism immune globulinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJan 1998
- Study completionJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant BotulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Department of Health Services
- Sponsor type
- University, hospital or other
- Investigators
- Stephen S. Arnon, Study chair, California Department of Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004401
- Sponsor's protocol ID
- 199/13253
- Other IDs
- CDHS-FDU000476
- Status last verified
- Mar 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Human Botulism Immunoglobulin in Infants With Botulism
- ClinicalTrials.gov ID
- NCT00004401
- Acronym / sponsor ID
- 199/13253
- Conditions
- Infant Botulism, Botulism
- Keywords
- bacterial infection, clostridium infection, immunologic disorders and infectious disorders, infant botulism, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- California Department of Health ServicesUniversity, hospital or other
- Study start
- Jan 1998
- Study completion
- Jun 1998
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulism immune globulin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen S. Arnon study chair
California Department of Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulism immune globulin in people with Infant Botulism and Botulism, run by California Department of Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.