Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract
|First Received Date ICMJE||March 5, 2006|
|Last Updated Date||January 15, 2012|
|Start Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00299663 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract|
|Official Title ICMJE||Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Cross-Sectional|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|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.|
|Condition ICMJE||Streptococcal Infections|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00299663|
|Other Study ID Numbers ICMJE||GAS-HMO-CTIL|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Ahinoam Lev-Sagie, MD, Hadassah Medical Organization|
|Study Sponsor ICMJE||Hadassah Medical Organization|
|Collaborators ICMJE||Not Provided|
|PRS Account||Hadassah Medical Organization|
|Verification Date||January 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP