Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305123
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2006-03-17
Brief Title:
Molecular Epidemiology of Streptococcus Pyogenes Among Children in Bamako Mali
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Molecular Epidemiology of Streptococcus Pyogenes Among Children in Bamako Mali Bamako BGAS2000
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 12000 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
Detailed Description:
Data on the epidemiology of group A streptococci GAS infection in developing countries is limited Available publications suggest that not only is disease prevalent but severe manifestations continue to occur at a high rate Several promising GAS vaccine candidates are in pre-clinical and clinical development One approach that has entered clinical trial is the use of a multivalent recombinant fusion peptide vaccine containing amino-terminal M protein fragments In animal models these M-protein type-specific epitopes induce protective opsonic antibodies that do not cross-react with human tissues If type-specific vaccines are to be used in developing countries then the molecular epidemiology of GAS in these settings must be better characterized The primary objective of this study is to identify the genotypes emm type or sub-type of GAS isolated from 5 to 16 year old schoolchildren with pharyngitis living in a poor urban community in Bamako Mali The secondary objectives are to characterize the molecular epidemiology of GAS pharyngitis among Malian schoolchildren by determining the distribution of genotypes according to age in years year of study and season cold or dry to estimate the incidence of GAS pharyngitis among 5 to 16 year old schoolchildren living in a poor urban community in Bamako Mali overall and by age gender year of study and season and to describe the clinical features of GAS pharyngitis among the Malian schoolchildren Surveillance for pharyngitis will be conducted at least twice weekly among a cohort of approximately 12000 children ages 5-16 attending the four public elementary schools in Djikoroni-para-Sébénikoro a low-income community in Bamako Mali Throat swabs will be obtained when a child enrolled in the cohort complains of a sore throat GAS isolated from the swabs will be characterized by emm typing The primary endpoint of the study is the proportion of each emm-type among children with GAS pharyngitis The secondary endpoints include the following 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 the proportion of children with pharyngitis from whom GAS is isolated the minimal incidence of GAS pharyngitis per 100000 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 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 and the 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 It is clear that GAS is an important worldwide pathogen and that it has been understudied in much of the developing world Given the early successes of multivalent M type-specific vaccines investigations of the molecular epidemiology delineating the distribution of the emm-types of the organism associated with pharyngitis and therefore presumably acute rheumatic fever are crucial for designing a vaccine that has utility in preventing rheumatic heart disease and other GAS disease in the developing world The current protocol is intended to provide data to address these goals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Bamako BGAS2000 | None | None | None |