Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 15% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (340 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-09-26, after 2019-10-11 start.
Reason given by the sponsor: “efficacy”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-09-26. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Sponsor's past termination rate: 23.6% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: admissionpriortime ofthe timeobjective
Phrases that lowered it: severeliver50single doseat time -
Phase: 1 (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 10.9% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 25 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Design: parallel (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 50 (lowers risk) · Who can join
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Keywords listed: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 81.0% (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 72 (typical: 32)
- Sponsor's past termination rate
- 23.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 25 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 40416 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6323 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, urogenital
- Drugs matched to FDA substances
- metronidazole
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women NCT04638257 · started 2013 · scored riskier than 92% of active trials completed
- Prevention of Persistence of Bacterial Vaginosis NCT00741845 · started 2008 · scored riskier than 21% of active trials terminated
- Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology NCT02527941 · started 2015 · scored riskier than 6% of active trials completed
- Randomized Controlled Trial of Treatment of Male Partners of Women With BV NCT02209519 · started 2015 · scored riskier than 36% of active trials completed
- A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women NCT02210689 · started 2014 · scored riskier than 11% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.