NCT00844038

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

Same day

First QC Date

February 12, 2009

Last Update Submit

February 12, 2009

Conditions

Stevens-Johnson Syndrome

Keywords

Steven-Johnson syndromeerythema multiformautoimmune disease

Study Arms (1)

1

Sick

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

1

You may qualify if:

  • Stevens-Johnson syndrome associated with antimicrobial

You may not qualify if:

  • Not sick

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pernambuco

Recife, Pernambuco, 52021220, Brazil

Location

Related Publications (1)

  • Vanfleteren I, Van Gysel D, De Brandt C. Stevens-Johnson syndrome: a diagnostic challenge in the absence of skin lesions. Pediatr Dermatol. 2003 Jan-Feb;20(1):52-6. doi: 10.1046/j.1525-1470.2003.03012.x.

    PMID: 12558848RESULT

MeSH Terms

Conditions

Stevens-Johnson SyndromeAutoimmune Diseases

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Edwaldo Dr Dourado, Doctor

    University of Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

August 1, 2008

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

BR(1)