Prognostic Indicators of Recurrence of Bacterial Vaginosis

ABSTRACTFollowing all forms of therapy for bacterial vaginosis (BV), recurrence rates are extremely high. Many diagnostic tests are available that differentiate bacterial vaginosis from other types of vaginal disorders, but none predict recurrence after treatment, nor are any vetted for monitoring ongoing responses to treatment. Our goal was to determine which tests, and at what optimal times, have prognostic value in predicting recurrence. This prospective cohort study monitored 74 highly recurrent BV patients for up to 9 months. Symptomatic BV patients were treated with oral metronidazole and were evaluated at cessation of treatment and monthly. Index tests included Amsel, Nugent, BV Blue, and Affirm VPIII, as well as a quantitative PCR (qPCR)-based test under initial evaluation here. The qPCR-based LbRC (LactobacillusRelativeComposition) assay predicted BV recurrence when performed shortly after oral metronidazole treatment, with both 90% positive predictive values (PPV) and 74% negative predictive values (NPV); the Nugent scores had 93% PPV but poor NPV (57%). No test, at any other visit, was prognostic. The LbRC assay and, to a lesser extent, Nugent tests scored a week after oral metronidiazole predicted recurrence, suggesting that the recurrence in this cohort was predominantly by relapse due to incomplete restoration of eubiosis soon after therapy. This is the first study in an under evaluated population of recurrent BV patients that emphasizes the need for and a pathway to a possible prognostic modality. Given the high recurrence rates of BV, prognostic tests that could influence individualized treatment alternatives are urgently needed.

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Faculty Opinions recommendation of High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.14169.471671 ◽

2006 ◽

Author(s):

Bryan Larsen

Keyword(s):

Bacterial Vaginosis ◽

Recurrence Rates ◽

Factors Associated ◽

Oral Metronidazole

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High Recurrence Rates of Bacterial Vaginosis over the Course of 12 Months after Oral Metronidazole Therapy and Factors Associated with Recurrence

The Journal of Infectious Diseases ◽

10.1086/503780 ◽

2006 ◽

Vol 193 (11) ◽

pp. 1478-1486 ◽

Cited By ~ 324

Author(s):

Catriona S. Bradshaw ◽

Anna N. Morton ◽

Jane Hocking ◽

Suzanne M. Garland ◽

Margaret B. Morris ◽

...

Keyword(s):

Bacterial Vaginosis ◽

Recurrence Rates ◽

Factors Associated ◽

Oral Metronidazole

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The Effect of Oral Metronidazole on the Vaginal Microbiome of Patients with Recurrent Bacterial Vaginosis: A Pilot Investigational Study

Human Microbiome Journal ◽

10.1016/j.humic.2021.100081 ◽

2021 ◽

pp. 100081

Author(s):

Oluwatosin Goje ◽

Elizabeth O. Shay ◽

Metabel Markwei ◽

Roshan Padmanabhan ◽

Charis Eng

Keyword(s):

Bacterial Vaginosis ◽

Vaginal Microbiome ◽

Oral Metronidazole

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Clindamycin Vaginal Cream Versus Oral Metronidazole in the Treatment of Bacterial Vaginosis

Southern Medical Journal ◽

10.1097/00007611-199211000-00006 ◽

1992 ◽

Vol 85 (11) ◽

pp. 1077-1080 ◽

Cited By ~ 24

Author(s):

FRANK J. ANDRES ◽

REBECCA PARKER ◽

IAN HOSEIN ◽

GUY I. BENRUBI

Keyword(s):

Bacterial Vaginosis ◽

Vaginal Cream ◽

Oral Metronidazole

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Combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis

International Journal of Gynecology & Obstetrics ◽

10.1002/ijgo.12805 ◽

2019 ◽

Vol 145 (3) ◽

pp. 261-267

Author(s):

Wichinee Chooprasertsuk ◽

Woraluk Somboonporn ◽

Sukree Soontrapa ◽

LingLing Salang ◽

Siriruthai Amnatbuddee

Keyword(s):

Bacterial Vaginosis ◽

Benzalkonium Chloride ◽

Vaginal Administration ◽

Oral Metronidazole

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Diagnostic and prognostic value of the D-dimer test in emergency department patients: secondary analysis of an observational study

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2019-0391 ◽

2019 ◽

Vol 57 (11) ◽

pp. 1730-1736 ◽

Cited By ~ 1

Author(s):

Alaadin Vögeli ◽

Mohammad Ghasemi ◽

Claudia Gregoriano ◽

Angelika Hammerer ◽

Sebastian Haubitz ◽

...

Keyword(s):

Emergency Department ◽

False Positive ◽

Prognostic Value ◽

Secondary Analysis ◽

Area Under The Curve ◽

Thromboembolic Disease ◽

Predictive Values ◽

Emergency Department Patients ◽

D Dimer ◽

Rule Out

Abstract Background D-dimer measurement improves the rule-out of thromboembolic disease. However, little is known about the risk of false positive results for the diagnosis of thromboembolic disease and its prognostic value. Herein, we investigated factors influencing the accuracy of D-dimer and its prognostic value in a large cohort of emergency department (ED) patients. Methods This is a secondary analysis of a prospective observational single center, cohort study. Consecutive patients, for whom a D-dimer test was requested by the treating physician, were included. Associations of clinical parameters on admission with false positive D-dimer results for the diagnosis of thromboembolic disease were investigated with logistic regression analysis. Results A total of 3301 patients were included, of which 203 (6.1%) had confirmed thromboembolic disease. The negative and positive predictive values of the D-dimer test at the 0.5 mg/L cut-off were 99.9% and 11.4%, respectively. Several factors were associated with positive D-dimer results potentially falsely indicating thromboembolic disease in multivariate analysis including advanced age (odds ratio [OR] 1.04, 95% confidence interval [CI] 1.04–1.05, p < 0.001), congestive heart failure (CHF) (OR 2.79, 95% CI 1.77–4.4, p < 0.01), renal failure (OR 2.00, 95% CI 1.23–3.24, p = 0.005), history of malignancy (OR 2.6, 95% CI 1.57–4.31, p < 0.001), C-reactive protein (CRP) (OR 1.02, 95% CI 1.01–1.02, p < 0.001) and glomerular filtration rate (GFR) (OR 0.99, 95% CI 0.99–1.00, p = 0.003). Regarding its prognostic value, D-dimer was associated with a 30-day mortality (adjusted OR 1.05, 95% CI 1.02–1.09, p = 0.003) with an area under the curve (AUC) of 0.79. Conclusions While D-dimer allows an accurate rule-out of thromboembolic disease, its positive predictive value in routine ED patients is limited and largely influenced by age, comorbidities and acute disease factors. The strong prognostic value of D-dimer in this population warrants further investigation.

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Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

BMC Infectious Diseases ◽

10.1186/s12879-020-05563-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lenka A. Vodstrcil ◽

◽

Erica L. Plummer ◽

Michelle Doyle ◽

Christopher K. Fairley ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bacterial Vaginosis ◽

Controlled Trial ◽

Male Partner ◽

Standard Of Care ◽

Trial Registration ◽

Current Standard ◽

Randomised Controlled ◽

Oral Metronidazole ◽

Amsel Criteria

Abstract Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

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Prognostic Value of the Neurological Examination in Cardiac Arrest Patients After Therapeutic Hypothermia

The Neurohospitalist ◽

10.1177/1941874417733217 ◽

2017 ◽

Vol 8 (2) ◽

pp. 66-73 ◽

Cited By ~ 8

Author(s):

Elizabeth A. Matthews ◽

Jessica Magid-Bernstein ◽

Evie Sobczak ◽

Angela Velazquez ◽

Cristina Maria Falo ◽

...

Keyword(s):

Cardiac Arrest ◽

Therapeutic Hypothermia ◽

Neurological Examination ◽

Prognostic Value ◽

Strong Predictor ◽

Cerebral Performance Category ◽

Light Response ◽

Columbia University ◽

Predictive Values ◽

Poor Outcome

Objectives: Current prognostication guidelines for cardiac arrest (CA) survivors predate the use of therapeutic hypothermia (TH). The prognostic value and ideal timing of the neurological examination remain unknown in the setting of TH. Design: Patients (N = 291) admitted between 2007 and 2015 to Columbia University intensive care units for TH following CA had neurological examinations performed on days 1, 3, 5, and 7 postarrest. Absent pupillary light response (PLR), absent corneal reflexes (CRs), and Glasgow coma scores motor (GCS-M) no better than extension were considered poor examinations. Poor outcome was recorded as cerebral performance category score ≥3 at discharge and 1 year. Predictive values of examination maneuvers were calculated for each time point. Main Results: Among the 137 survivors to day 7, sensitivities and negative predictive values were low at all time points. The PLR had false positive rates (FPRs) of 0% and positive predictive values (PPV) of 100% from day 3 onward. For the CR and GCS-M, the FPRs decreased from day 3 to 5 (9% vs 3%; 21% vs 9%), while PPVs increased (91% vs 96%; 90% vs 95%). Excluding patients who died due to withdrawal of life-sustaining therapy (WLST) did not significantly affect FPRs or PPVs, nor did assessing outcome at 1 year. Conclusions: A poor neurological examination remains a strong predictor of poor outcome, both at hospital discharge and at 1 year, independent of WLST. Following TH, the predictive value of the examination is insufficient at day 3 and should be delayed until at least day 5, with some additional benefit beyond day 5.

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Prognostic value of post-induction PET/CT in untreated multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT).

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e21006 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e21006-e21006

Author(s):

Lale Kostakoglu ◽

David Dingli ◽

Meral Beksac ◽

Elena Zamagni ◽

Tomer Martin Mark ◽

...

Keyword(s):

Prognostic Value ◽

Progression Free Survival ◽

Scoring Systems ◽

Prognostic Indicators ◽

Cell Transplant ◽

Liver Uptake ◽

Durable Response ◽

Pet Ct ◽

Inadequate Sample Size

e21006 Background: Induction with novel biological agents has significantly improved progression free survival (PFS) of MM pts. However, role and timing of ASCT is unclear and there remains a need for a practical means to predict post-ASCT outcome. Our goal was to determine the prognostic value of FDG PET/CT (PET) after induction therapy (IT) in comparison with other prognostic factors and International Myeloma Working Group (IMWG) response criteria. Methods: Prospective, multicenter study of 113 newly diagnosed MM pts undergoing IT+ASCT. IT was not controlled and consisted of 2 or 3 novel agent combinations. The tested variables to predict PFS are shown in table. Two PET scoring systems were used: Score1, positive>marrow uptake; Score2, positive>liver uptake. ROC analysis determined the SUV cut-off. Results: With a median follow-up of 29.5 mo 56 (49.6%) pts relapsed (median PFS: 24.3 mo). Results are displayed in table. Post-IT, when a "+" PET (Score2) was associated with less than a VGPR response, relapses occurred in 83% of pts vs. in only 30% when PET was "-" and pts were in CR or VGPR. Multivariate analysis revealed only ISS to be an independent predictor of PFS (p=0.014). Conclusions: Post-IT a "-" PET associated with CR+VGPR suggests a durable response. Qualitative PET evaluation using a more liberal threshold (liver) to define positivity can be used to accurately assess response in MM. These data failed to prove the post-IT IMWG and PET response to be independent prognosticators while ISS was a superior predictor. This may be attributed to inadequate sample size, nonuniform pre- and post-ASCT treatments, varying follow-up times. Further analyses with stratifying various prognostic indicators and therapy schemes in a larger population are underway to determine a definitive role for PET as a predictor of post-ASCT outcome. [Table: see text]

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