Group B Streptococcal Infection Clinical Trial
Official title:
Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
NCT number | NCT02814318 |
Other study ID # | 16-008 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | October 2019 |
Verified date | March 2020 |
Source | TriHealth Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this project is to identify the duration of vancomycin administration at which
group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal
mucosa. This will aid in labor management and delivery planning to ensure that the mother
receives adequate GBS prophylaxis while also minimizing the duration of exposure to
vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic
workup of neonates whose mothers received vancomycin intrapartum.
This study aims to identify the time after administration of IV vancomycin at which GBS
colonies are 100% eradicated.
Status | Terminated |
Enrollment | 41 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Vancomycin Arm Inclusion Criteria - Women aged 18 years or older - Pregnancies of at least 37w0d gestation at delivery - History of high-risk allergy to penicillin (including pruritic rash, urticaria, swelling, anaphylaxis) - Women who are GBS positive - Culture proven resistance or - Unknown resistance to clindamycin or erythromycin Exclusion Criteria - Women with low risk allergy to penicillin - History of allergy to vancomycin - History of Red Man Syndrome - History of renal or hepatic disease - Immunocompromised patients - History of chronic steroid use in current pregnancy - Patient with fever or signs of chorioamnionitis on admission Penicillin Arm Inclusion Criteria - Women aged 18 years or older - Women who are GBS positive - Pregnancies of at least 37w0d gestation at delivery Exclusion Criteria - Immunocompromised patients - History of chronic steroid use in current pregnancy - Patient with fever or signs of chorioamnionitis on admission |
Country | Name | City | State |
---|---|---|---|
United States | Bethesda North Hospital | Cincinnati | Ohio |
United States | Good Samaritan Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
TriHealth Inc. |
United States,
Knight KM, Thornburg LL, McNanley AR, Hardy DJ, Vicino D, Glantz JC. The effect of intrapartum clindamycin on vaginal group B streptococcus colony counts. J Matern Fetal Neonatal Med. 2012 Jun;25(6):747-9. doi: 10.3109/14767058.2011.591458. Epub 2011 Jul 22. — View Citation
Laiprasert J, Klein K, Mueller BA, Pearlman MD. Transplacental passage of vancomycin in noninfected term pregnant women. Obstet Gynecol. 2007 May;109(5):1105-10. — View Citation
McNanley AR, Glantz JC, Hardy DJ, Vicino D. The effect of intrapartum penicillin on vaginal group B streptococcus colony counts. Am J Obstet Gynecol. 2007 Dec;197(6):583.e1-4. — View Citation
Onwuchuruba CN, Towers CV, Howard BC, Hennessy MD, Wolfe L, Brown MS. Transplacental passage of vancomycin from mother to neonate. Am J Obstet Gynecol. 2014 Apr;210(4):352.e1-352.e4. doi: 10.1016/j.ajog.2014.01.019. — View Citation
Paccione KA, Wiesenfeld HC. Guideline adherence for intrapartum group B streptococci prophylaxis in penicillin-allergic patients. Infect Dis Obstet Gynecol. 2013;2013:917304. doi: 10.1155/2013/917304. Epub 2013 Feb 12. — View Citation
Turrentine MA, Greisinger AJ, Brown KS, Wehmanen OA, Mouzoon ME. Duration of intrapartum antibiotics for group B streptococcus on the diagnosis of clinical neonatal sepsis. Infect Dis Obstet Gynecol. 2013;2013:525878. doi: 10.1155/2013/525878. Epub 2013 Mar 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GBS colonization levels after admission to labor and delivery | At 8 hours |
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