- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00844038
Stevens-Johnson Syndrome Antimicrobial
February 12, 2009 updated by: University of Pernambuco
Stevens-Johnson Syndrome Associated With Antimicrobial
Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance, with skin involvement and mucous membranes, related to several factors, such as, viral or bacterial infections and mainly the administration of medicines, in general painkillers and antibiotics.
The objective of this work is report the emergence of ulcerative vesicle -bubble chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old patient, leucoderma and masculine gender, in treatment of breathing infection with sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.
Study Overview
Status
Completed
Conditions
Detailed Description
Among the serious medicaments reactions, there are as great representative the Mucocutaneous Disorders immunological mediated.
Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance, with skin involvement and mucous membranes, related to several factors, such as, viral or bacterial infections and mainly the administration of medicines, in general painkillers and antibiotics.
The objective of this work is report the emergence of ulcerative vesicle -bubble chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old patient, leucoderma and masculine gender, in treatment of breathing infection with sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 52021220
- University of Pernambuco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
1
Description
Inclusion Criteria:
- Stevens-Johnson syndrome associated with antimicrobial
Exclusion Criteria:
- Not sick
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Sick
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edwaldo Dr Dourado, Doctor, University of Pernambuco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
February 12, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (Estimate)
February 13, 2009
Study Record Updates
Last Update Posted (Estimate)
February 13, 2009
Last Update Submitted That Met QC Criteria
February 12, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Skin Diseases
- Immune System Diseases
- Disease
- Stomatognathic Diseases
- Mouth Diseases
- Hypersensitivity
- Erythema
- Skin Diseases, Vesiculobullous
- Dermatitis
- Drug-Related Side Effects and Adverse Reactions
- Stomatitis
- Drug Eruptions
- Erythema Multiforme
- Drug Hypersensitivity
- Syndrome
- Stevens-Johnson Syndrome
Other Study ID Numbers
- SSJ1
- 558187121279
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.