Group A Beta Hemolytic Streptococcal (GAS) InfectionNCT00342199
Surveillance of Streptococcal Infections in Children in India
An observational study of Group A Beta Hemolytic Streptococcal (GAS) Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Group A Beta Hemolytic Streptococcal (GAS) Infection
- How many people
- 663 participants
- Where
- 2 sitesIndia
- Study dates
- 3 Jul 2001to 26 Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All students (approximately 225-250) attending four classes in four rural schools, grades 2-5, in rural villages near Chandigarh, and all students in classes 2-6 approximately 225-250 attending one rural village school near Vellore were asked to participate.
- Approximately an equal number of boys and girls participated.
- Selection of the schools for the study was determined by such factors as the accessibility to a rural regional clinic, housing facilities for medical staff, and passable tertiary roads to the villages and the schools.
Who cannot join
- All volunteers had a history of acute rheumatic fever and acute glomerulonephritis and evidence of rheumatic fever and rheumatic heart disease on physical examination at the initial survey were excluded from the study.
- Excluded also was a child with a compromising illness such as cystic fibrosis that might require frequent or intermittent antibiotic treatment.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Post Graduate Institute of Medical and Experimental Research
Chandigarh
Christian Medical College
Vellore
About this study
Official title: Epidemiological Surveillance in India of Group A Streptococcal Infections Including Pharyngitis and Impetigo Supported by Indo-US Vaccine Action Program
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.
Read more
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 world's 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 locale(s) 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.
...
Read the 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,
- 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
- 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 vaccine(s) 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.
- Keywords
- Incidence, Prevalence, Immunity, Bacteriology, Pathogenesis
- Medical subject headings
- Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start3 Jul 2001
- Study completion26 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Group A Beta Hemolytic Streptococcal (GAS) InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Dean A Follmann, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342199
- Sponsor's protocol ID
- 999901190
- Other IDs
- 01-I-N190
- Status last verified
- 26 Feb 2014
- First submitted
- 19 Jun 2006
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Schwartz B, Facklam RR, Breiman RF. Changing epidemiology of group A streptococcal infection in the USA. Lancet. 1990 Nov 10;336(8724):1167-71. doi: 10.1016/0140-6736(90)92777-f.
PubMed 1978035Kaplan EL. T. Duckett Jones Memorial Lecture. Global assessment of rheumatic fever and rheumatic heart disease at the close of the century. Influences and dynamics of populations and pathogens: a failure to realize prevention? Circulation. 1993 Oct;88(4 Pt 1):1964-72. doi: 10.1161/01.cir.88.4.1964. No abstract available.
PubMed 8403347Gulley RL, Fex J, Wenthold RJ. Uptake of putative neurotransmitters in the organ of Corti. Acta Otolaryngol. 1979;88(3-4):177-82. doi: 10.3109/00016487909137157.
PubMed 40384
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Surveillance in India of Group A Streptococcal Infections Including Pharyngitis and Impetigo Supported by Indo-US Vaccine Action Program
- ClinicalTrials.gov ID
- NCT00342199
- Acronym / sponsor ID
- 999901190
- Keywords
- Incidence, Prevalence, Immunity, Bacteriology, Pathogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 3 Jul 2001
- Study completion
- 26 Feb 2014
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 world's 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 locale(s) 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,
- 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
- 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 vaccine(s) 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 design
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All students (approximately 225-250) attending four classes in four rural schools, grades 2-5, in rural villages near Chandigarh, and all students in classes 2-6 approximately 225-250 attending one rural village school near Vellore were asked to participate.
- Approximately an equal number of boys and girls participated.
- Selection of the schools for the study was determined by such factors as the accessibility to a rural regional clinic, housing facilities for medical staff, and passable tertiary roads to the villages and the schools.
Key exclusion criteria (2 listed)
- All volunteers had a history of acute rheumatic fever and acute glomerulonephritis and evidence of rheumatic fever and rheumatic heart disease on physical examination at the initial survey were excluded from the study.
- Excluded also was a child with a compromising illness such as cystic fibrosis that might require frequent or intermittent antibiotic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 1978035Schwartz B, Facklam RR, Breiman RF. Changing epidemiology of group A streptococcal infection in the USA. Lancet. 1990 Nov 10;336(8724):1167-71. doi: 10.1016/0140-6736(90)92777-f.
- Background: PubMed 8403347Kaplan EL. T. Duckett Jones Memorial Lecture. Global assessment of rheumatic fever and rheumatic heart disease at the close of the century. Influences and dynamics of populations and pathogens: a failure to realize prevention? Circulation. 1993 Oct;88(4 Pt 1):1964-72. doi: 10.1161/01.cir.88.4.1964. No abstract available.
- Background: PubMed 40384Gulley RL, Fex J, Wenthold RJ. Uptake of putative neurotransmitters in the organ of Corti. Acta Otolaryngol. 1979;88(3-4):177-82. doi: 10.3109/00016487909137157.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean A Follmann, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group A Beta Hemolytic Streptococcal (GAS) Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342199, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.