Streptococcal InfectionsNCT00299663
Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract
An observational study of Streptococcal Infections, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Group A streptococcus (GAS) causes a variety of human infections. It is also an uncommon but serious cause of postpartum infections. In contrast to group B streptococcus (GBS) infection, which causes illness and death in newborns disproportionately more often than it does in mothers, perinatal GAS infection primarily… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Streptococcal Infections
- How many people
- 61 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2006to Oct 2011
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population that participate in the study are women who were udentified with positive culture of group A streptoccoci in the genital tracts, starting from 2003 and on.
Who may be able to join
- Patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Group A streptococcus (GAS) causes a variety of human infections. It is also an uncommon but serious cause of postpartum infections. In contrast to group B streptococcus (GBS) infection, which causes illness and death in newborns disproportionately more often than it does in mothers, perinatal GAS infection primarily affects mothers . Invasive GAS infection is defined by the isolation of GAS from a normally sterile site (e.g., blood) or by the isolation of GAS from a nonsterile site in the presence of the streptococcal toxic shock syndrome or necrotizing fasciitis. A postpartum case of invasive GAS is defined as isolation of GAS during the postpartum period, in association with a clinical postpartum infection (e.g., endometritis) or from either a sterile site or a wound infection.
Because of the burden and severity of invasive GAS infection, the Centers for Disease Control and Prevention (CDC) hosted a meeting in to formulate guidelines for responding to postpartum and postsurgical GAS infections. However, we could not find any recommendations for long-term follow-up of patients who had GAS infection subsequent to delivery or gynaecological procedures, or further recommendations regarding subsequent delivery or gynaecological invasive procedures. It is possible that women who had GAS as a cause of vaginal infection may have a tendency to be carriers of this organism, but this has never been proven. We believe it is of importance to determine if women who have had one infection may be long-term carriers which may pose a risk during future pregnancies.
Read more
The objective of the present study is to evaluate the incidence of long term gynaecological carrier state of patients who had GAS invasive infection following delivery, and to provide guidelines for follow-up and treatment of such patients.
The proposed study may answer the question whether this endogenous GAS origin represents chronic GAS carrier state, similar to the known GBS carrier state. As some of these patients had severe infections (sometimes life threatening) a protocol for long-term follow up and management is necessary in case an invasive procedure is done (IUD insertion, endometrial biopsy, curettage or delivery) in order to prevent recurrent infection. The information collected in the study will enable us to afford recommendations for follow up and prophylaxis in the future.
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Read the detailed description
Research plan The study population will include patients diagnosed with GAS invasive infection following delivery or gynaecological procedures (such as endometrial biopsy, D\&C or IUD insertion) at Hadassah university hospitals, and patients in whom an isolation of GAS from the vagina without infection was reported. The study will consist of two parts, prospective and retrospective.
- Retrospective study
- The records of all patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005) will be reviewed. The estimated occurrence of GAS isolation from the genital tract in Hadassah hospital is 15 cases every year (Moses personal communication).
- Patients' files will be reviewed for demographic and clinical variables associated with the development of GAS infection (age, parity, obstetric history), its clinical course and subsequent progress to septic shock, and the site of GAS isolation (blood, vaginal discharge, wound etc).
- Additional information will be obtained from the patients in order to evaluate the incidence of gynaecological infections and risk factors for such infections. These include events of pelvic inflammatory disease, contraceptive methods, subsequent deliveries or D\&C (a questionnaire is attached).
- Vaginal cultures and pharyngeal swabs will be taken from all women with previous gynecological GAS infection/isolation participating in the study, in order to evaluate whether carriage of GAS in the vagina occurs.
- emm typing Since we have the original isolates from women with invasive disease (those presenting with bacteremia) we will be able to compare the specific type isolate obtained in consequent cultures with the original isolate. Isolates will be compared by several known bacterial attributes such as emm type, T type, and the presence of genes for the different exotoxins. emm typing PCR of streptococcal isolates will be performed as previously described [11], according to the recommendations of the Division of Bacterial and Mycotic Diseases, Streptococcus pyogenes emm sequence database (http://www.cdc.gov/ncidod/biotech/strep/doc.htm).
- Prospective study- In addition to the above patients, women presenting from the beginning of the study for two years, with an isolation of GAS from the vagina (even without overt disease), will be followed in order to evaluate the significance of such isolates. These isolates will be collected for comparison with surveillance cultures which will be taken in the future. Vaginal cultures and pharyngeal swabs will be taken every 2 months during the year.
- Conditions
- Streptococcal Infections
- Keywords
- group A streptococcal infection, genital tract, CARRIER, patients with GAS isolation, Streptococcus Group A
- Medical subject headings
- Streptococcal Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startFeb 2006
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Streptococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- ALLON MOSES, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299663
- Sponsor's protocol ID
- GAS-HMO-CTIL
- Status last verified
- Jan 2012
- First submitted
- 5 Mar 2006
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Chuang I, Van Beneden C, Beall B, Schuchat A. Population-based surveillance for postpartum invasive group a streptococcus infections, 1995-2000. Clin Infect Dis. 2002:15;35:665-70. 2. Centers for Disease Control and Prevention. Active bacterial core surveillance (ABCs) report: group A Streptococcus, 2000. 3. The Working Group on Severe Streptococcal Infections. Defining the group A streptococcal toxic shock syndrome. Rationale and consensus definition. JAMA 1993; 269:390 1. 4. Stevens DL, Tanner MH, Winship J, et al. Severe group A streptococcal infections associated with a toxic shock like syndrome and scarlet fever toxin A. N Engl J Med 1989; 321:1 7. 5. Centers for Disease Control and Prevention. Case definitions for infectious conditions under public health surveillance. MMWR Recomm Rep 1997;46(RR-10):1 55. 6. Prevention of Invasive Group A Streptococcal Infections Workshop Participants .Prevention of invasive group A streptococcal disease among household contacts of case patients and among postpartum and postsurgical patients: recommendations from the Centers for Disease Control and Prevention. Clin Infect Dis. 2003 15;36:243.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract
- ClinicalTrials.gov ID
- NCT00299663
- Acronym / sponsor ID
- GAS-HMO-CTIL
- Conditions
- Streptococcal Infections
- Keywords
- group A streptococcal infection, genital tract, CARRIER, patients with GAS isolation, Streptococcus Group A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Mar 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.
Group A streptococcus (GAS) causes a variety of human infections. It is also an uncommon but serious cause of postpartum infections. In contrast to group B streptococcus (GBS) infection, which causes illness and death in newborns disproportionately more often than it does in mothers, perinatal GAS infection primarily affects mothers . Invasive GAS infection is defined by the isolation of GAS from a normally sterile site (e.g., blood) or by the isolation of GAS from a nonsterile site in the presence of the streptococcal toxic shock syndrome or necrotizing fasciitis. A postpartum case of invasive GAS is defined as isolation of GAS during the postpartum period, in association with a clinical postpartum infection (e.g., endometritis) or from either a sterile site or a wound infection.
Because of the burden and severity of invasive GAS infection, the Centers for Disease Control and Prevention (CDC) hosted a meeting in to formulate guidelines for responding to postpartum and postsurgical GAS infections. However, we could not find any recommendations for long-term follow-up of patients who had GAS infection subsequent to delivery or gynaecological procedures, or further recommendations regarding subsequent delivery or gynaecological invasive procedures. It is possible that women who had GAS as a cause of vaginal infection may have a tendency to be carriers of this organism, but this has never been proven. We believe it is of importance to determine if women who have had one infection may be long-term carriers which may pose a risk during future pregnancies.
The objective of the present study is to evaluate the incidence of long term gynaecological carrier state of patients who had GAS invasive infection following delivery, and to provide guidelines for follow-up and treatment of such patients.
The proposed study may answer the question whether this endogenous GAS origin represents chronic GAS carrier state, similar to the known GBS carrier state. As some of these patients had severe infections (sometimes life threatening) a protocol for long-term follow up and management is necessary in case an invasive procedure is done (IUD insertion, endometrial biopsy, curettage or delivery) in order to prevent recurrent infection. The information collected in the study will enable us to afford recommendations for follow up and prophylaxis in the future.
.
Detailed description
Research plan The study population will include patients diagnosed with GAS invasive infection following delivery or gynaecological procedures (such as endometrial biopsy, D\&C or IUD insertion) at Hadassah university hospitals, and patients in whom an isolation of GAS from the vagina without infection was reported. The study will consist of two parts, prospective and retrospective.
- Retrospective study
- The records of all patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005) will be reviewed. The estimated occurrence of GAS isolation from the genital tract in Hadassah hospital is 15 cases every year (Moses personal communication).
- Patients' files will be reviewed for demographic and clinical variables associated with the development of GAS infection (age, parity, obstetric history), its clinical course and subsequent progress to septic shock, and the site of GAS isolation (blood, vaginal discharge, wound etc).
- Additional information will be obtained from the patients in order to evaluate the incidence of gynaecological infections and risk factors for such infections. These include events of pelvic inflammatory disease, contraceptive methods, subsequent deliveries or D\&C (a questionnaire is attached).
- Vaginal cultures and pharyngeal swabs will be taken from all women with previous gynecological GAS infection/isolation participating in the study, in order to evaluate whether carriage of GAS in the vagina occurs.
- emm typing Since we have the original isolates from women with invasive disease (those presenting with bacteremia) we will be able to compare the specific type isolate obtained in consequent cultures with the original isolate. Isolates will be compared by several known bacterial attributes such as emm type, T type, and the presence of genes for the different exotoxins. emm typing PCR of streptococcal isolates will be performed as previously described [11], according to the recommendations of the Division of Bacterial and Mycotic Diseases, Streptococcus pyogenes emm sequence database (http://www.cdc.gov/ncidod/biotech/strep/doc.htm).
- Prospective study- In addition to the above patients, women presenting from the beginning of the study for two years, with an isolation of GAS from the vagina (even without overt disease), will be followed in order to evaluate the significance of such isolates. These isolates will be collected for comparison with surveillance cultures which will be taken in the future. Vaginal cultures and pharyngeal swabs will be taken every 2 months during the year.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population that participate in the study are women who were udentified with positive culture of group A streptoccoci in the genital tracts, starting from 2003 and on.
Key inclusion criteria (1 listed)
- Patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005)
Key exclusion criteria (0 listed)
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 18 Jan 2012.
- Background1. Chuang I, Van Beneden C, Beall B, Schuchat A. Population-based surveillance for postpartum invasive group a streptococcus infections, 1995-2000. Clin Infect Dis. 2002:15;35:665-70. 2. Centers for Disease Control and Prevention. Active bacterial core surveillance (ABCs) report: group A Streptococcus, 2000. 3. The Working Group on Severe Streptococcal Infections. Defining the group A streptococcal toxic shock syndrome. Rationale and consensus definition. JAMA 1993; 269:390 1. 4. Stevens DL, Tanner MH, Winship J, et al. Severe group A streptococcal infections associated with a toxic shock like syndrome and scarlet fever toxin A. N Engl J Med 1989; 321:1 7. 5. Centers for Disease Control and Prevention. Case definitions for infectious conditions under public health surveillance. MMWR Recomm Rep 1997;46(RR-10):1 55. 6. Prevention of Invasive Group A Streptococcal Infections Workshop Participants .Prevention of invasive group A streptococcal disease among household contacts of case patients and among postpartum and postsurgical patients: recommendations from the Centers for Disease Control and Prevention. Clin Infect Dis. 2003 15;36:243.
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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.
ALLON MOSES study director
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Infections, run by Hadassah Medical Organization at 1 site in Israel.
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 0 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 18 Jan 2012. 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 Israel. 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 NCT00299663, which also lists 1 linked publication.
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 18 Jan 2012.