Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
Stopped early
Conditions studied: Group B Streptococcal Infection
In brief
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.
Key facts
- Study ID
- NCT02814318
- Run by
- TriHealth Inc.
- People needed
- 41
- Starts
- 2016-06-01
- Expected to finish
- 2019-10-01
- Last updated by the study team
- 2020-04-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
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
- 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
Where it is running
- Good Samaritan Hospital — Cincinnati, Ohio, United States
- Bethesda North Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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