Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers

NCT02393586 on ClinicalTrials.gov Phase 1 National University Hospital, Singapore (academic or other) Started 2015-02-28 Completed

Riskier than 2% of active trials

Model scores of the 29,894 trials active now.

Model score 3% for any early termination, 1% 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

Completed on 2015-10-31, after 2015-02-28 start.

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 2015-10-31. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: evidenceknowncurrent useuse ofwilling and
Phrases that lowered it: healthyvolunteerssinglepharmacokineticswhole blood
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 2.2% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Minimum age: 21 (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 34 (lowers risk) · Sponsor's track record
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 10.8% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 46 (lowers risk) · Sponsor's track record
Blinding: none (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area

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: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 21 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 46 (typical: 32)
Sponsor's past termination rate: 2.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 34 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 6 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 30069 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5833 (typical: 412.5)
Drug's FAERS reports marked serious: 87.9% (typical: 85.6%)
Drug's FAERS reports with a death: 10.8% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: amoxicillin, amoxicillin clavulanate, amoxicillin clavulanic acid, clavulanic acid, faropenem, rifampin

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

Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers NCT02381470 · started 2019 · scored riskier than 22% of active trials completed
Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers NCT02602509 · started 2015 · scored riskier than 3% of active trials completed
Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Pyrazinamide Plus Allopurinol in Healthy Volunteers NCT02700347 · started 2016 · scored riskier than 3% of active trials completed
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010) NCT00944021 · started 2009 · scored riskier than 9% of active trials completed
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers NCT00990990 · started 2009 · scored riskier than 13% 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.