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Streptococcus Group ANCT00170521

Mol Epi GrAS in Nicaragua

An observational study of Streptococcus Group A, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Nicaragua.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the epidemiology of throat isolates of group A streptococci among 3-15 year-old children with pharyngitis (sore throat) living in Leon, Nicaragua. Read more about this study

Who is it for?
Ages 3 to 15 years
Conditions the study is for
Streptococcus Group A
How many people
13,000 participants
Where
1 siteNicaragua
Study dates
Aug 2006to Aug 2008
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 3 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1. All children 3- to 15-years old with pharyngitis who are seen at a participating site will be invited to participate.

Who cannot join

  • Subjects whose parents are unable or unwilling to provide informed consent will be excluded from the study.
  • Children who are 13 years or older and unable or unwilling to provide informed consent will be excluded form the study.

Trial locations and contacts

1 site in 1 country.

Nicaragua1 site
  • National Autonomous University of Nicaragua, Leon

    León

About this study

Official title: The Molecular Epidemiology of Streptococcus Pyogenes Among Children in Leon, Nicaragua

The purpose of this study is to determine the epidemiology of throat isolates of group A streptococci among 3-15 year-old children with pharyngitis (sore throat) living in Leon, Nicaragua.

Read the detailed description

Streptococcus pyogenes (GrAS) is a human pathogen that leads to great disease burden throughout the world. In the United States, an estimated 30 million infections occur yearly. Most of these are local infections of the skin or the throat but still lead to considerable use of health-care resources. These common, simple forms of GrAS disease may progress to or be followed by the more serious GrAS-related illnesses acute rheumatic fever, post-streptococcal glomerulonephritis, streptococcal toxic shock syndrome, sepsis, pneumonia, or other invasive illnesses. Outside the U.S., in the developing world, the burden of GrAS-related disease is presumed to be even higher, but is not completely elucidated in many of the poorer regions of the world. It is known, though, that rheumatic heart disease causes more cardiovascular morbidity in the children of the world than any other illness. Although the incidence of rheumatic fever in the U.S. has fallen to levels of approximately 0.5 per 100,000 per year, in some areas, the developing world's children still have rates over 100 per 100,000 per year. The percentage of cardiac admissions attributable to rheumatic heart disease in hospitals located in the developing world remains in the range of 30 to 50%, where it has been studied. GrAS is one of the best characterized human pathogens with regards to its microbiology, its spectrum of diseases, and its ability to lead to serious sequelae such as rheumatic fever and glomerulonephritis. Yet, efforts to control it through the use of antibiotics have been only partially successful in the United States and largely unsuccessful in the developing world. The health impact of uncomplicated streptococcal infections, such as pharyngitis, and the less common but more severe diseases, such as rheumatic heart disease, must be better studied in order to move forward with control measures. In this study, patients aged 3-15 presenting with sore throat, fever and cervical lymphadenopathy will be examined and a throat swab will be submitted to the lab for culture. All of these patients will be treated with either benzathine penicillin or, if they have a history of allergy to penicillin, oral erythromycin. The parent will be given a follow-up appointment to convey the result of the culture and to evaluate the course of the child's illness. Children presenting with sore throat only will be cultured and given a follow-up appointment to return after the result of the culture is known. Antibiotic treatment is given only if the culture is positive for group A streptococci. Within this algorithm is latitude for the physician to treat any patient based on clinical signs and symptoms and the concern that a particular child may not return for treatment if it is delayed based on the culture result. The overriding goal is the prevention of acute rheumatic fever and suppurative complications. The primary objective of this study is to characterize the GrAS isolates genotypically (emm type or sub-type). The secondary objective is to describe the epidemiology of throat isolates of GrAS among 3- to 15- year old children with pharyngitis living in Leon, Nicaragua. Primary endpoint of the study is the frequency and proportion of each emm-type among children with pharyngitis. Secondary Endpoints for the study are as follows: The proportion of children with pharyngitis from whom GrAS is isolated. The minimal incidence of GrAS pharyngitis in children based on annual cases per 100,000 children in the catchment areas. The age, gender, and ethnicity-specific minimal incidence rates of GrAS pharyngitis in children living in the catchment areas.

Keywords
group A streptococci, pharyngitis, epidemiology, Streptococcus pyogenes, children, Nicaragua
Medical subject headings
Pharyngitis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startAug 2006
  3. Study completionAug 2008

Resources

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
13,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00170521
Sponsor's protocol ID
05-0018
Other IDs
Leon GrAS2000
Status last verified
Dec 2006
First submitted
12 Sep 2005
Last updated
27 Aug 2010
Results posted
No

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 1 site in Nicaragua.

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 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: stopped early, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nicaragua. 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 was stopped early. Results are not available in the source record.

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 27 Aug 2010.

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