Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization

NCT02814318 | Terminated

• 1 other identifier: 16-008
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Group B Streptococcal Infection

Keywords

Vancomycin; Penicillin; Clindamycin; Group B streptococcal infection; Rectovaginal GBS colonization; Vaginal GBS colonization; Intrapartum; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• GBS colonization levels after admission to labor and delivery

  At 8 hours

Study Arms (2)

IV Vancomycin

GBS positive laboring women who are allergic to penicillin and clindamycin and are treated using IV vancomycin.

Biological: Vaginal and rectovaginal swab cultures

IV Penicillin

GBS positive laboring women who are not allergic to penicillin and are treated using IV penicillin.

Biological: Vaginal and rectovaginal swab cultures

Interventions

Vaginal and rectovaginal swab cultures BIOLOGICAL

The only intervention that will occur in this study is obtaining vaginal and recto-vaginal swab cultures upon admission to the labor and delivery room and every two hours to follow until 8 hours after administration of IV vancomycin or IV penicillin.

IV Penicillin; IV Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GBS positive laboring women aged at least 18 years old with pregnancies of 37 weeks gestational age or greater.

You may qualify if:

• 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

You may not qualify if:

• 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
• Women aged 18 years or older
• Women who are GBS positive
• Pregnancies of at least 37w0d gestation at delivery
• Immunocompromised patients
• History of chronic steroid use in current pregnancy
• Patient with fever or signs of chorioamnionitis on admission

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (2)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Related Publications (6)

• 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.

  PMID: 23476109 BACKGROUND

• 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.

  PMID: 21780879 BACKGROUND

• 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. doi: 10.1016/j.ajog.2007.08.045.

  PMID: 18060942 BACKGROUND

• 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.

  PMID: 23606801 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000260388.78339.b6.

  PMID: 17470590 BACKGROUND

• 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.

  PMID: 24679944 BACKGROUND

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• William Kim Brady, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 27, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)