Fluconazole Versus Micafungin in Neonates With Candidiasis
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 7% of the time (56 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-11-30, after 2014-10-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2015-11-30. 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
-
Sponsor's past termination rate: 18.6% (raises risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: evidencehoursto determinetime oftreatment of
Phrases that lowered it: pharmacokineticthe pharmacokineticsparticipantsto comparecompare the -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports with a death: 25.8% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 30 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 0.46 (lowers risk) · Who can join
-
Disease area, infectious disease: Yes (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Keywords listed: 6 (lowers risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Phase: 2/3 (lowers risk) · Design
-
Maximum age: 0.81 (raises risk) · Who can join
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 0.46 (typical: 18)
- Maximum age
- 0.81 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 43 (typical: 32)
- Sponsor's past termination rate
- 18.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 30 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 19854 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2758 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- fluconazole, micafungin
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
- Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis NCT00815516 · started 2013 · scored riskier than 16% of active trials terminated
- Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight NCT00734539 · started 2008 · scored riskier than 13% of active trials completed
- Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064) NCT01945281 · started 2014 · scored riskier than 85% of active trials terminated
- Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis NCT03421002 · started 2015 · scored riskier than 56% of active trials completed
- Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease NCT02172768 · started 2014 · scored riskier than 48% 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.