Group B Streptococcal InfectionNCT02814318
Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
An observational study of Group B Streptococcal Infection, run by TriHealth Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcal Infection
- What is being tested?
- Vaginal and rectovaginal swab cultures
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: GBS positive laboring women aged at least 18 years old with pregnancies of 37 weeks gestational age or greater.
Who may be able to join
- 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
Show all 9Show fewer
- Women aged 18 years or older
- Women who are GBS positive
- Pregnancies of at least 37w0d gestation at delivery
Who cannot join
- 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
Show all 11Show fewer
- Patient with fever or signs of chorioamnionitis on admission
- Penicillin Arm
- Immunocompromised patients
- History of chronic steroid use in current pregnancy
- Patient with fever or signs of chorioamnionitis on admission
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
About this study
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.
Read the 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.
- Conditions
- Group B Streptococcal Infection
- Being tested
- Vaginal and rectovaginal swab cultures
- Keywords
- Vancomycin, Penicillin, Clindamycin, Group B streptococcal infection, Rectovaginal GBS colonization, Vaginal GBS colonization, Intrapartum, Prophylaxis
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal and rectovaginal swab culturesBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| IV Vancomycin | GBS positive laboring women who are allergic to penicillin and clindamycin and are treated using IV vancomycin. Receives: Biological: Vaginal and rectovaginal swab cultures | |
| IV Penicillin | GBS positive laboring women who are not allergic to penicillin and are treated using IV penicillin. Receives: Biological: Vaginal and rectovaginal swab cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
GBS colonization levels after admission to labor and delivery
Measured: At 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: Ancef (Cefazolin) became the new standard of care (instead of Vancomycin) for GBS prophylaxis if the patient is allergic to penicillin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Group B Streptococcal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Kim Brady, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814318
- Sponsor's protocol ID
- 16-008
- Status last verified
- Mar 2020
- First submitted
- 9 Jun 2016
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23476109Knight 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.
PubMed 21780879McNanley 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.
PubMed 18060942Turrentine 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.
PubMed 23606801Laiprasert 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.
PubMed 17470590Onwuchuruba 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.
PubMed 24679944
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
- ClinicalTrials.gov ID
- NCT02814318
- Acronym / sponsor ID
- 16-008
- Conditions
- Group B Streptococcal Infection
- Keywords
- Vancomycin, Penicillin, Clindamycin, Group B streptococcal infection, Rectovaginal GBS colonization, Vaginal GBS colonization, Intrapartum, Prophylaxis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ancef (Cefazolin) became the new standard of care (instead of Vancomycin) for GBS prophylaxis if the patient is allergic to penicillin.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Vancomycin | – | Biological: Vaginal and rectovaginal swab culturesGBS positive laboring women who are allergic to penicillin and clindamycin and are treated using IV vancomycin. |
| IV Penicillin | – | Biological: Vaginal and rectovaginal swab culturesGBS positive laboring women who are not allergic to penicillin and are treated using IV penicillin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- GBS positive laboring women aged at least 18 years old with pregnancies of 37 weeks gestational age or greater.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal and rectovaginal swab culturesThe 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. | Biological | IV Penicillin, IV Vancomycin |
Primary outcome
GBS colonization levels after admission to labor and delivery
Time frame: At 8 hours
Results and safety
The study was stopped early (reason given: Ancef (Cefazolin) became the new standard of care (instead of Vancomycin) for GBS prophylaxis if the patient is allergic to penicillin.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Background: PubMed 23476109Paccione 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.
- Background: PubMed 21780879Knight 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.
- Background: PubMed 18060942McNanley 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.
- Background: PubMed 23606801Turrentine 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.
- Background: PubMed 17470590Laiprasert 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.
- Background: PubMed 24679944Onwuchuruba 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Kim Brady, MD principal investigator
TriHealth Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group B Streptococcal Infection, run by TriHealth Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Ancef (Cefazolin) became the new standard of care (instead of Vancomycin) for GBS prophylaxis if the patient is allergic to penicillin.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GBS colonization levels after admission to labor and delivery (time frame: At 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814318, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.