Streptococcal Infections Clinical Trial
Official title:
Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: Labor and Delivery Study
NCT number | NCT00330642 |
Other study ID # | HandyLab #VVP00103 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | May 26, 2006 |
Last updated | December 14, 2015 |
Start date | July 2006 |
Verified date | December 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The purpose of this study is to determine whether a rapid bedside diagnosis of group B strep (GBS) growing in the vagina and rectum can be performed with similar success to the routine culture in women who are in labor.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women 18 years of age or older - Mentally capable of giving informed consent - Symptoms and signs at presentation related to possible labor or ruptured membranes (leakage of fluid, uterine contractions, pelvic pressure) - Presentation for induction of labor irrespective of cause Exclusion Criteria: - Inability to give informed consent - Conditions where the time taken to obtain specimens are potentially harmful to one or one's baby (heavy bleeding, low fetal heart rate, preterm premature rupture of membranes) - Use of any antibacterials within the previous 7 days |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Hospital | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
ACOG committee opinion. Prevention of early-onset group B streptococcal disease in newborns. Number 173--June 1996. Committee on Obstetric Practice. American College of Obstetrics and Gynecologists. Int J Gynaecol Obstet. 1996 Aug;54(2):197-205. Review. — View Citation
Bergeron MG, Ke D, Ménard C, Picard FJ, Gagnon M, Bernier M, Ouellette M, Roy PH, Marcoux S, Fraser WD. Rapid detection of group B streptococci in pregnant women at delivery. N Engl J Med. 2000 Jul 20;343(3):175-9. — View Citation
Boyer KM, Gotoff SP. Prevention of early-onset neonatal group B streptococcal disease with selective intrapartum chemoprophylaxis. N Engl J Med. 1986 Jun 26;314(26):1665-9. — View Citation
Centers for Disease Control and Prevention (CDC). Laboratory practices for prenatal Group B streptococcal screening and reporting--Connecticut, Georgia, and Minnesota, 1997-1998. MMWR Morb Mortal Wkly Rep. 1999 May 28;48(20):426-8. — View Citation
Edwards RK, Clark P, Duff P. Intrapartum antibiotic prophylaxis 2: positive predictive value of antenatal group B streptococci cultures and antibiotic susceptibility of clinical isolates. Obstet Gynecol. 2002 Sep;100(3):540-4. — View Citation
Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC. MMWR Recomm Rep. 2002 Aug 16;51(RR-11):1-22. — View Citation
Walker CK, Crombleholme WR, Ohm-Smith MJ, Sweet RL. Comparison of rapid tests for detection of group B streptococcal colonization. Am J Perinatol. 1992 Jul;9(4):304-8. — View Citation
Yancey MK, Armer T, Clark P, Duff P. Assessment of rapid identification tests for genital carriage of group B streptococci. Obstet Gynecol. 1992 Dec;80(6):1038-47. Review. — View Citation
Yancey MK, Schuchat A, Brown LK, Ventura VL, Markenson GR. The accuracy of late antenatal screening cultures in predicting genital group B streptococcal colonization at delivery. Obstet Gynecol. 1996 Nov;88(5):811-5. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02052973 -
Efficacy of Propolis Varnish Against Oral Biofilm
|
Phase 1/Phase 2 | |
Completed |
NCT01412801 -
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
|
Phase 2 | |
Completed |
NCT00884728 -
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
|
N/A | |
Completed |
NCT01193920 -
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
|
Phase 1/Phase 2 | |
Terminated |
NCT00261742 -
Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis
|
Phase 4 | |
Completed |
NCT00169481 -
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine
|
Phase 2 | |
Completed |
NCT02270944 -
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
|
Phase 2 | |
Completed |
NCT03055728 -
Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
|
||
Withdrawn |
NCT00598429 -
Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
|
Phase 2 | |
Completed |
NCT01030731 -
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
|
Phase 1 | |
Completed |
NCT04100772 -
Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above
|
Phase 1 | |
Completed |
NCT01118143 -
Oral Health Literacy Tailored Communication
|
N/A | |
Completed |
NCT01026740 -
Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00299663 -
Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract
|
N/A | |
Completed |
NCT00646958 -
Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
|
Phase 2 | |
Completed |
NCT01026636 -
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
|
Phase 1 | |
Completed |
NCT00514527 -
A Study for Patients With Complicated Skin and Skin Structure Infections
|
Phase 2 | |
Completed |
NCT01026558 -
A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
|
Phase 1 | |
Completed |
NCT01156740 -
Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
|
N/A | |
Completed |
NCT04841369 -
Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)
|
Phase 3 |