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Streptococcus Group ANCT00305123

Molecular Epidemiology of Streptococcus Pyogenes Among Children in Bamako, Mali

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to learn more about sore throats caused by the germ Group A Streptococcus (GAS) or "Strep". When "Strep" causes a sore throat, it can be treated with medicines called antibiotics. However, if not treated, it can lead to heart problems and other serious diseases. Read more about this study

Who is it for?
Ages 5 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Streptococcus Group A
How many people
1,757 participants
Where
1 siteMali
Study dates
Apr 2006to Sep 2009
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 5 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: 5-16 year old children with complaints consistent with pharyngitis attending 4 public schools in Bamako, Mali.

Who may be able to join

  • 5 to 16 years old (at enrollment/beginning of the school year).
  • Enrolled at one of the 4 participating elementary schools in Djikoroni-para/Sébénikoro.
  • A parent or guardian provides informed, written consent.
  • A child 13 years or older (at enrollment/beginning of the school year) who provides assent.

Who cannot join

  • No exclusion criteria included in this protocol.

Trial locations and contacts

1 site in 1 country.

Mali1 site
  • Center for Vaccine Development - Mali

    Bamako, Bamako

Other trials in Mali

About this study

Official title: The Molecular Epidemiology of Streptococcus Pyogenes Among Children in Bamako, Mali (Bamako BGAS2000)

The purpose of this study is to learn more about sore throats caused by the germ Group A Streptococcus (GAS) or "Strep". When "Strep" causes a sore throat, it can be treated with medicines called antibiotics. However, if not treated, it can lead to heart problems and other serious diseases. This study will identify the different types of "Strep" that are present in children with sore throats. Researchers will check children with sore throats at least twice weekly among a group of approximately 12,000 children. Study participants will include children, ages 5-16, attending the public elementary schools in Djikoroni-Sébénikoro, a low income community in Bamako, Mali. Throat swabs will be obtained and free treatment is available when a child enrolled in the group complains of a sore throat. The information from this study may help make a vaccine to prevent "Strep" infection in Malian children. Children may participate for the 3 year duration of the study.

Read the detailed description

Data on the epidemiology of group A streptococci (GAS) infection in developing countries is limited. Available publications suggest that not only is disease prevalent, but severe manifestations continue to occur at a high rate. Several promising GAS vaccine candidates are in pre-clinical and clinical development. One approach that has entered clinical trial is the use of a multivalent recombinant fusion peptide vaccine containing amino-terminal M protein fragments. In animal models, these M-protein type-specific epitopes induce protective opsonic antibodies that do not cross-react with human tissues. If type-specific vaccines are to be used in developing countries, then the molecular epidemiology of GAS in these settings must be better characterized. The primary objective of this study is to identify the genotypes (emm type or sub-type) of GAS isolated from 5 to 16 year old schoolchildren with pharyngitis living in a poor urban community in Bamako, Mali. The secondary objectives are: to characterize the molecular epidemiology of GAS pharyngitis among Malian schoolchildren by determining the distribution of genotypes according to age in years, year of study, and season (cold or dry); to estimate the incidence of GAS pharyngitis among 5 to 16 year old schoolchildren living in a poor urban community in Bamako, Mali overall and by age, gender, year of study, and season; and to describe the clinical features of GAS pharyngitis among the Malian schoolchildren. Surveillance for pharyngitis will be conducted at least twice weekly among a cohort of approximately 12,000 children, ages 5-16, attending the four public elementary schools in Djikoroni-para-Sébénikoro, a low-income community in Bamako, Mali. Throat swabs will be obtained when a child enrolled in the cohort complains of a sore throat. GAS isolated from the swabs will be characterized by emm typing. The primary endpoint of the study is the proportion of each emm-type among children with GAS pharyngitis. The secondary endpoints include the following: the proportion of each emm-type among children with GAS pharyngitis overall and according to age in years, year of study, and season (cold or dry); the proportion of children with pharyngitis from whom GAS is isolated; the minimal incidence of GAS pharyngitis per 100,000 children in the catchment area of Djikoroni-para-Sébénikoro overall and according to: age in years, gender, year of study, and season (cold or dry); the incidence density (number of cases per children-weeks of follow up) of GAS pharyngitis among enrolled school children overall and according to: age in years, year of study, and season (cold or dry); and the proportion of children with GAS pharyngitis who experience symptoms such as fever, exudative pharyngitis, tender cervical adenopathy, or scarletiniform rash, overall and by age in years. It is clear that GAS is an important worldwide pathogen and that it has been understudied in much of the developing world. Given the early successes of multivalent M type-specific vaccines, investigations of the molecular epidemiology delineating the distribution of the emm-types of the organism associated with pharyngitis (and therefore presumably acute rheumatic fever) are crucial for designing a vaccine that has utility in preventing rheumatic heart disease and other GAS disease in the developing world. The current protocol is intended to provide data to address these goals.

Keywords
Pharyngitis, Mali, Group A Streptococcus, Children
Medical subject headings
Pharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00305123
Study groupRoleWhat they receive
112,000 children 5 to 16 years of age attending the 4 public elementary schools in Djikoroni-para-Sébénikoro, Bamako, Mali.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of each emm-type among children with GAS pharyngitis.

    Measured: Baseline day 0 through 3 year study period.

Secondary outcomes (5)
  1. Proportion of children with GAS pharyngitis who experience symptoms such as fever, exudative pharyngitis, tender cervical adenopathy, or scarletiniform rash, overall and by age in years.

    Measured: Baseline day 0 through 3 year study period.

  2. The incidence density (number of cases per children-weeks of follow up) of GAS pharyngitis among enrolled school children overall and according to: age in years, year of study, and season (cold or dry).

    Measured: Baseline day 0 through 3 year study period.

  3. The minimal incidence of GAS pharyngitis per 100,000 children in the catchment area of Djikoroni-para-Sébénikoro overall and according to: age in years, gender, year of study, and season (cold or dry).

    Measured: Baseline day 0 through 3 year study period.

  4. The proportion of each emm-type among children with GAS pharyngitis overall and according to: age in years, year of study, and season (cold or dry).

    Measured: Baseline day 0 through 3 year study period.

  5. The proportion of children with pharyngitis from whom GAS is isolated.

    Measured: Baseline day 0 through 3 year study period.

Timeline

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

  1. First posted21 Mar 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,757 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00305123
Sponsor's protocol ID
06-0002
Other IDs
Bamako BGAS2000
Status last verified
Oct 2009
First submitted
17 Mar 2006
Last updated
15 Feb 2013
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 Mali.

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 4 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 15 Feb 2013. 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 Mali. 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.

What does the primary outcome measure?

The proportion of each emm-type among children with GAS pharyngitis. (time frame: Baseline day 0 through 3 year study period.). It is what the study was designed to measure, not a finding.

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 15 Feb 2013.

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