Streptococcus Group A Clinical Trial
Official title:
The Molecular Epidemiology of Streptococcus Pyogenes Among Children in Bamako, Mali (Bamako BGAS2000)
The purpose of this study is to learn more about sore throats caused by the germ Group A Streptococcus (GAS) or "Strep". When "Strep" causes a sore throat, it can be treated with medicines called antibiotics. However, if not treated, it can lead to heart problems and other serious diseases. This study will identify the different types of "Strep" that are present in children with sore throats. Researchers will check children with sore throats at least twice weekly among a group of approximately 12,000 children. Study participants will include children, ages 5-16, attending the public elementary schools in Djikoroni-Sébénikoro, a low income community in Bamako, Mali. Throat swabs will be obtained and free treatment is available when a child enrolled in the group complains of a sore throat. The information from this study may help make a vaccine to prevent "Strep" infection in Malian children. Children may participate for the 3 year duration of the study.
Status | Completed |
Enrollment | 1757 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 16 Years |
Eligibility |
Inclusion Criteria: - 5 to 16 years old (at enrollment/beginning of the school year). - Enrolled at one of the 4 participating elementary schools in Djikoroni-para/Sébénikoro. - A parent or guardian provides informed, written consent. - A child 13 years or older (at enrollment/beginning of the school year) who provides assent. Exclusion Criteria: No exclusion criteria included in this protocol. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Mali | Center for Vaccine Development - Mali | Bamako |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
Mali,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of each emm-type among children with GAS pharyngitis. | Baseline day 0 through 3 year study period. | No | |
Secondary | Proportion of children with GAS pharyngitis who experience symptoms such as fever, exudative pharyngitis, tender cervical adenopathy, or scarletiniform rash, overall and by age in years. | Baseline day 0 through 3 year study period. | No | |
Secondary | The incidence density (number of cases per children-weeks of follow up) of GAS pharyngitis among enrolled school children overall and according to: age in years, year of study, and season (cold or dry). | Baseline day 0 through 3 year study period. | No | |
Secondary | The minimal incidence of GAS pharyngitis per 100,000 children in the catchment area of Djikoroni-para-Sébénikoro overall and according to: age in years, gender, year of study, and season (cold or dry). | Baseline day 0 through 3 year study period. | No | |
Secondary | The proportion of each emm-type among children with GAS pharyngitis overall and according to: age in years, year of study, and season (cold or dry). | Baseline day 0 through 3 year study period. | No | |
Secondary | The proportion of children with pharyngitis from whom GAS is isolated. | Baseline day 0 through 3 year study period. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00307112 -
Rheumatic Heart Disease Prevalence in Leon, Nicaragua
|
||
Completed |
NCT00284882 -
Incidence of Group A Strep Pharyngitis in School Children in Fiji
|
N/A | |
Completed |
NCT00284843 -
Prevalence of RHD, Pyoderma and Scabies in Children in Fiji
|
N/A | |
Completed |
NCT00436891 -
Streptococcal Infections in Fiji - Prevalence of Group A Streptococcal Pyoderma and Scabies in Infants in Fiji
|
N/A | |
Completed |
NCT00264771 -
Hospital Based Incidence of Group A Streptococcal Disease in Fiji
|
N/A | |
Completed |
NCT00264784 -
GAS Epi Study to Measure Age-Related Antibody Titers to J8 Vaccine
|
N/A | |
Terminated |
NCT00170521 -
Mol Epi GrAS in Nicaragua
|
N/A |