Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342199
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2006-06-19
Brief Title:
Surveillance of Streptococcal Infections in Children in India
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Epidemiological Surveillance in India of Group A Streptococcal Infections Including Pharyngitis and Impetigo Supported by Indo-US Vaccine Action Program
Status:
COMPLETED
Status Verified Date:
2014-02-26
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:
Information from this study is needed to plan an eventual trial of a GAS vaccine in India if and when one is available A GAS vaccine is currently a priority of the Indian Council for Medical Research ICMR and this project has been approved by the Joint Working Group US and Indian Delegates of the Vaccine Action Program a joint effort of the ICMR and NIAID to implement cooperative efforts between the two countries on mutual objectives in vaccine development Currently several GAS vaccines are in development supported by NIAID and other sources and one candidate is in phase one clinical trial authorized by the FDA Information on the antigenic structure of GAS isolated in India will be needed for planning vaccine composition It is the view of the Indian Ministry of Health and Indian Council for Medical Research that eventual prevention and control of rheumatic fever and rheumatic heart disease in India now a heavy burden on the children will require a GAS vaccine which requires both access to primary health care and a vaccine if and when it is available
Information on incidence is needed to determine the size of a future vaccine cohort in order to obtain a statistically significant result on vaccine efficacy Although unrelated to vaccine development information on the incidence of GAS pharyngitis is needed in India to implement primary and secondary acute rheumatic fever ARF and rheumatic heart disease RHD prevention programs as were implemented in the USA and Europe forty years ago
A vaccine trial is not part of this study nor is there any intervention other than antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo
An additional point should be made about the importance of obtaining epidemiological data on streptococcal disease in India and on the emm types of GAS that cause infections The population of India is over one billion people representing nearly twenty five percent of the worlds population Information on GAS epidemiology from India is scant to say the least and it is sorely needed We now know that streptococcal toxic shock syndrome and fasciitis that have occurred in the U S Europe Australia and Japan with greater frequency in recent years are caused by several genetically similar emm types of GAS The implication of such genetic and epidemiologic data is that these genetically related strains have spread worldwide Current information from India is far too limited to know if these virulent strains of GAS occur in India and if they do to what extent might they be the cause of frequent invasive disease in hospitalized patients
Equally important we do not know if a potentially high virulent GAS strain is currently emerging in some locales in India and what possible threat it might become if it were to be transported to other worldwide geographic regions Although not a specific aim of this proposal the surveillance conducted to accomplish the aims of this protocol will provide essential information on the possible emergence of an unexpected emm type with pathogenic potential
Information on incidence is needed to determine the size of a future vaccine cohort in order to obtain a statistically significant result on vaccine efficacy Although unrelated to vaccine development information on the incidence of GAS pharyngitis is needed in India to implement primary and secondary acute rheumatic fever ARF and rheumatic heart disease RHD prevention programs as were implemented in the USA and Europe forty years ago
A vaccine trial is not part of this study nor is there any intervention other than antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo
An additional point should be made about the importance of obtaining epidemiological data on streptococcal disease in India and on the emm types of GAS that cause infections The population of India is over one billion people representing nearly twenty five percent of the worlds population Information on GAS epidemiology from India is scant to say the least and it is sorely needed We now know that streptococcal toxic shock syndrome and fasciitis that have occurred in the U S Europe Australia and Japan with greater frequency in recent years are caused by several genetically similar emm types of GAS The implication of such genetic and epidemiologic data is that these genetically related strains have spread worldwide Current information from India is far too limited to know if these virulent strains of GAS occur in India and if they do to what extent might they be the cause of frequent invasive disease in hospitalized patients
Equally important we do not know if a potentially high virulent GAS strain is currently emerging in some locales in India and what possible threat it might become if it were to be transported to other worldwide geographic regions Although not a specific aim of this proposal the surveillance conducted to accomplish the aims of this protocol will provide essential information on the possible emergence of an unexpected emm type with pathogenic potential
Detailed Description:
This is an epidemiological study on the incidence of Group A beta hemolytic streptococcal GAS infections both pharyngitis and impetigo in school-age children in two rural area of India surveillance in four schools in the north in the Punjab near Chandigarh conducted by the medical staff of the Department of Community Medicine Post-graduate Institute for Medical Research and Training PGI and in one school in the south in Tamil Nadu near Vellore conducted by the medical staff of the Department of Community Medicine Christian Medical College CMC
Children and their teachers were questioned weekly for a history of GAS infection On all children suspected from the history of a streptococcal infection of the pharynx or the skin a physical examination of nose throat ears and skin was performed and throat culture and or skin culture and blood sample were taken for subsequent antibody determination The diagnosis of GAS infection was made on the basis of established clinical criteria and the isolation of GAS from throat and skin lesion cultures
The surveillance of the children was completed in March 04 in Vellore and in April 04 in Chandigarh For the next year there will be extensive analysis of the clinical data analysis of the isolated GAS for emm type and other bacteriologic characteristics and epidemiologic analysis in a search for patterns of distribution of GAS infections by sex age school and session
The general objectives have been
To establish population-based surveillance to determine the incidence of GAS infection in school children age 7-11 to characterize the M protein of the newly isolated strains of GAS by emm gene sequencing
1 to identify surrogate markers of protective immunity relevant to vaccine development such as serum antibody to the M type-specific peptides and cysteine protease and
2 to define the molecular epidemiology of GAS in terms of those characteristics that are relevant to vaccine-induced immunity
Information from this study is needed to plan an eventual trial of a vaccines if and when one is available Information on the antigenic structure of GAS isolated in India will be needed for planning vaccine composition Information on incidence is needed to determine the size of a future cohort that will be needed to obtain a statistically significant result on vaccine efficacy
A vaccine trial is not part of this study nor was there any intervention other than diagnostic procedures and antibiotic treatment of all who develop a GAS infection
Children and their teachers were questioned weekly for a history of GAS infection On all children suspected from the history of a streptococcal infection of the pharynx or the skin a physical examination of nose throat ears and skin was performed and throat culture and or skin culture and blood sample were taken for subsequent antibody determination The diagnosis of GAS infection was made on the basis of established clinical criteria and the isolation of GAS from throat and skin lesion cultures
The surveillance of the children was completed in March 04 in Vellore and in April 04 in Chandigarh For the next year there will be extensive analysis of the clinical data analysis of the isolated GAS for emm type and other bacteriologic characteristics and epidemiologic analysis in a search for patterns of distribution of GAS infections by sex age school and session
The general objectives have been
To establish population-based surveillance to determine the incidence of GAS infection in school children age 7-11 to characterize the M protein of the newly isolated strains of GAS by emm gene sequencing
1 to identify surrogate markers of protective immunity relevant to vaccine development such as serum antibody to the M type-specific peptides and cysteine protease and
2 to define the molecular epidemiology of GAS in terms of those characteristics that are relevant to vaccine-induced immunity
Information from this study is needed to plan an eventual trial of a vaccines if and when one is available Information on the antigenic structure of GAS isolated in India will be needed for planning vaccine composition Information on incidence is needed to determine the size of a future cohort that will be needed to obtain a statistically significant result on vaccine efficacy
A vaccine trial is not part of this study nor was there any intervention other than diagnostic procedures and antibiotic treatment of all who develop a GAS infection
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 |
|---|---|---|---|
| 01-I-N190 | None | None | None |