Streptococcus Group ANCT00264771
Hospital Based Incidence of Group A Streptococcal Disease in Fiji
An observational study of Streptococcus Group A, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Fiji.
Trial summary
The purpose of this ongoing study (Part II) is to estimate the incidence of acute rheumatic fever, rheumatic heart disease, acute post-streptococcal glomerulonephritis (kidney disease), and invasive group A streptococcal (GAS) disease (strep infection) in Fiji to help develop better treatments and vaccines. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Streptococcus Group A
- How many people
- 550 participants
- Where
- 2 sitesFiji
- Study dates
- Dec 2005to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent will be obtained from all study participants. Children between 0 -17 years of age will be enrolled in the APSGN study. Children between 3-17 years of age and adults between 18-40 years will be enrolled in the ARF study. Children and adults of all ages will be enrolled in the RHD and invasive GAS studies.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Fiji2 sites
Lautoka Hospital
Lautoka
Colonial War Memorial Hospital
Suva
About this study
Official title: The Hospital Based Incidence of Acute Rheumatic Fever and Rheumatic Heart Disease, Acute Post Streptococcal Glomerulonephritis and Invasive Group A Streptococcal Disease in Fiji
The purpose of this ongoing study (Part II) is to estimate the incidence of acute rheumatic fever, rheumatic heart disease, acute post-streptococcal glomerulonephritis (kidney disease), and invasive group A streptococcal (GAS) disease (strep infection) in Fiji to help develop better treatments and vaccines. Group A streptococcal disease is caused by the bacterium group A streptococcus. It is commonly found in the nose and throat of normal healthy adults and children, and can cause illness. The bacterium is spread by close contact with patients or carriers, through things like coughing, sneezing, kissing, or sharing a drink and can cause a wide variety of illnesses. These illnesses may be a sore throat, skin sores, and less commonly acute rheumatic fever or kidney disease. Participants of all ages will be recruited through the Colonial War Memorial and Lautoka Hospital. A blood sample will be collected from each study participant. Subject participation should be less than one day.
Read the detailed description
This study is a prospective active surveillance study of group A streptococcal (GAS) diseases across two hospital sites designed to estimate the local incidence of acute rheumatic fever (ARF), rheumatic heart disease (RHD), acute post streptococcal glomerulonephritis (APSGN) and invasive GAS disease. It is part II of a series of 5 studies including DMID protocols 05-0081, 05-0117, 05-0118, and 06-0081. The study is also designed to assess the clinical features of these GAS diseases. The study will also provide detailed information about the molecular epidemiology of GAS from these diseases. The study will establish an active surveillance system for cases of ARF and APSGN and invasive GAS disease at the Colonial War Hospital, in Suva Fiji and at Lautoka Hospital, Lautoka. In addition, the study will establish an active surveillance system for patients presenting with complications of established RHD at the Colonial War Memorial Hospital in Suva Fiji. The primary objectives of the study are to estimate the incidence of: acute rheumatic fever in the Western and Central divisions of Fiji in children 3-17 years of age and adults 18-40 years; RHD in all ages in the Central division of Fiji; APSGN in the Western and Central divisions of Fiji in children 0-17 years of age; and invasive GAS disease in the Western and Central divisions of Fiji in all ages. The secondary objectives of the study are to: describe the clinical features of patients presenting with complications of established RHD in the central division of Fiji; establish an ongoing surveillance system for GAS diseases in the Western and Central divisions; describe the clinical features of patients presenting with ARF, APSGN and invasive GAS disease in Fiji; genotypically characterize GAS isolates from patients with ARF, APSGN and invasive GAS disease in Fiji; and measure anti-J8 antibodies in patients with GAS disease. The primary endpoints of the study are to determine the incidence of: confirmed and probable ARF, both first presentation and recurrent cases; RHD in all ages in the Central division of Fiji; confirmed and probable APSGN; and confirmed and probable invasive GAS disease. The secondary endpoints of the study include: incidence of heart failure, atrial fibrillation, stroke and infective endocarditis in patients with RHD presenting to Colonial War Memorial Hospital; distribution of symptoms and signs of ARF in patients presenting to hospital with ARF; distribution of sites of infection in cases of invasive GAS disease; incidence of necrotizing fasciitis and streptococcal toxic shock syndrome; proportion of GAS isolates from patients with ARF, APSGN and invasive GAS disease that contain the J8 epitope and the overall emm-type distribution of GAS isolates; characterization of GAS isolates (C repeat region sequencing and emm-typing); and measurement of anti-J8 antibodies in patients with GAS disease.
- Conditions
- Streptococcus Group A
- Keywords
- Fiji, Group A streptococcus, rheumatic, glomerulonephritis
- Medical subject headings
- Glomerulonephritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startDec 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Group AStudies 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
- Time perspective
- Prospective
- Enrolment
- 550 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264771
- Sponsor's protocol ID
- 05-0082
- Status last verified
- Oct 2007
- First submitted
- 9 Dec 2005
- Last updated
- 2 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hospital Based Incidence of Acute Rheumatic Fever and Rheumatic Heart Disease, Acute Post Streptococcal Glomerulonephritis and Invasive Group A Streptococcal Disease in Fiji
- ClinicalTrials.gov ID
- NCT00264771
- Acronym / sponsor ID
- 05-0082
- Conditions
- Streptococcus Group A
- Keywords
- Fiji, Group A streptococcus, rheumatic, glomerulonephritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2005
- Study completion
- Dec 2007
- First posted
- 13 Dec 2005 (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.
The purpose of this ongoing study (Part II) is to estimate the incidence of acute rheumatic fever, rheumatic heart disease, acute post-streptococcal glomerulonephritis (kidney disease), and invasive group A streptococcal (GAS) disease (strep infection) in Fiji to help develop better treatments and vaccines. Group A streptococcal disease is caused by the bacterium group A streptococcus. It is commonly found in the nose and throat of normal healthy adults and children, and can cause illness. The bacterium is spread by close contact with patients or carriers, through things like coughing, sneezing, kissing, or sharing a drink and can cause a wide variety of illnesses. These illnesses may be a sore throat, skin sores, and less commonly acute rheumatic fever or kidney disease. Participants of all ages will be recruited through the Colonial War Memorial and Lautoka Hospital. A blood sample will be collected from each study participant. Subject participation should be less than one day.
Detailed description
This study is a prospective active surveillance study of group A streptococcal (GAS) diseases across two hospital sites designed to estimate the local incidence of acute rheumatic fever (ARF), rheumatic heart disease (RHD), acute post streptococcal glomerulonephritis (APSGN) and invasive GAS disease. It is part II of a series of 5 studies including DMID protocols 05-0081, 05-0117, 05-0118, and 06-0081. The study is also designed to assess the clinical features of these GAS diseases. The study will also provide detailed information about the molecular epidemiology of GAS from these diseases. The study will establish an active surveillance system for cases of ARF and APSGN and invasive GAS disease at the Colonial War Hospital, in Suva Fiji and at Lautoka Hospital, Lautoka. In addition, the study will establish an active surveillance system for patients presenting with complications of established RHD at the Colonial War Memorial Hospital in Suva Fiji. The primary objectives of the study are to estimate the incidence of: acute rheumatic fever in the Western and Central divisions of Fiji in children 3-17 years of age and adults 18-40 years; RHD in all ages in the Central division of Fiji; APSGN in the Western and Central divisions of Fiji in children 0-17 years of age; and invasive GAS disease in the Western and Central divisions of Fiji in all ages. The secondary objectives of the study are to: describe the clinical features of patients presenting with complications of established RHD in the central division of Fiji; establish an ongoing surveillance system for GAS diseases in the Western and Central divisions; describe the clinical features of patients presenting with ARF, APSGN and invasive GAS disease in Fiji; genotypically characterize GAS isolates from patients with ARF, APSGN and invasive GAS disease in Fiji; and measure anti-J8 antibodies in patients with GAS disease. The primary endpoints of the study are to determine the incidence of: confirmed and probable ARF, both first presentation and recurrent cases; RHD in all ages in the Central division of Fiji; confirmed and probable APSGN; and confirmed and probable invasive GAS disease. The secondary endpoints of the study include: incidence of heart failure, atrial fibrillation, stroke and infective endocarditis in patients with RHD presenting to Colonial War Memorial Hospital; distribution of symptoms and signs of ARF in patients presenting to hospital with ARF; distribution of sites of infection in cases of invasive GAS disease; incidence of necrotizing fasciitis and streptococcal toxic shock syndrome; proportion of GAS isolates from patients with ARF, APSGN and invasive GAS disease that contain the J8 epitope and the overall emm-type distribution of GAS isolates; characterization of GAS isolates (C repeat region sequencing and emm-typing); and measurement of anti-J8 antibodies in patients with GAS disease.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent will be obtained from all study participants. Children between 0 -17 years of age will be enrolled in the APSGN study. Children between 3-17 years of age and adults between 18-40 years will be enrolled in the ARF study. Children and adults of all ages will be enrolled in the RHD and invasive GAS studies.
Key exclusion criteria (1 listed)
- None
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 2 May 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Streptococcus Group A, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Fiji.
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 1 inclusion and 1 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 2 May 2008. 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 Fiji. 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?
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 2 May 2008.