Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00170521 |
| Other study ID # |
05-0018 |
| Secondary ID |
Leon GrAS2000 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
September 12, 2005 |
| Last updated |
August 26, 2010 |
| Start date |
August 2006 |
| Est. completion date |
August 2008 |
Study information
| Verified date |
December 2006 |
| Source |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical 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.
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.
