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Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization

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ClinicalTrials.gov Identifier: NCT02814318
Recruitment Status : Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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.


Condition or disease Intervention/treatment
Group B Streptococcal Infection Biological: Vaginal and rectovaginal swab cultures

Detailed Description:

Prophylaxis of group B streptococcus has been a major component of prenatal care in preventing early onset of neonatal sepsis. While penicillin remains the gold standard medication for prophylaxis, this medication is not an option in women who have high risk allergic reactions to this class of medications. Furthermore, with rising rates of antibiotic resistance to erythromycin and clindamycin, more women are requiring vancomycin for GBS prophylaxis. While the CDC and ACOG recommend vancomycin as an alternative to penicillin for GBS prophylaxis, little research has been conducted investigating the transplacental passage of vancomycin.

Because of the gap in knowledge regarding intrapartum effects of IV vancomycin on GBS colonization, neonates of women who received vancomycin are considered as inadequately treated for GBS prophylaxis, and subsequently undergo additional observation, prolonged hospitalization, and possible septic workup in the immediate postpartum period. Because of this gap in knowledge, this research study investigates how quickly vaginal and recto-vaginal GBS colonization is eradicated to aid in timing of delivery in patients with GBS colonization who require vancomycin intrapartum.

In addition, the studies that investigated the duration of time of IV penicillin and IV clindamycin necessary for eradication of GBS colonization only investigated vaginal colonization, not recto-vaginal colonization. Their rationale was based on the assumption that most cases of neonatal GBS sepsis are caused by vaginal colonization. Given that the standard of care for GBS screening includes screening for colonization of both vaginal and rectal mucosa, investigators also plan to compare rates of eradication of GBS in vaginal colonies compared to recto-vaginal colonies.


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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
Study Start Date : June 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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
GBS positive laboring women who are not allergic to penicillin and are treated using IV penicillin.
Biological: Vaginal and rectovaginal swab cultures
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.




Primary Outcome Measures :
  1. GBS colonization levels after admission to labor and delivery [ Time Frame: At 8 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814318


Locations
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United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: William Kim Brady, MD TriHealth Inc.

Publications:
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02814318     History of Changes
Other Study ID Numbers: 16-008
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by TriHealth Inc.:
Vancomycin
Penicillin
Clindamycin
Group B streptococcal infection
Rectovaginal GBS colonization
Vaginal GBS colonization
Intrapartum
Prophylaxis

Additional relevant MeSH terms:
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Vancomycin
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Clindamycin
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action