Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients

NCT01049022 on ClinicalTrials.gov Phase 1 Bayer (industry) Started 2010-05-31 Completed

Riskier than 34% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 6% 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 (776 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 2013-08-31, after 2010-05-31 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 2013-08-31. 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) (raises risk) · Wording Phrases that raised it: chronicintravenouschildrendiseasehours
Phrases that lowered it: pharmacokineticssafety ofpatientsbodytaking
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Design: single group (raises risk) · Design
Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 129 (lowers risk) · Sponsor's track record
Sponsor's past trials: 320 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Maximum age: 14 (raises risk) · Who can join
Number of arms: 3 (lowers 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: 3 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: basic science (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 0.25 (typical: 18)
Maximum age: 14 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 320 (typical: 32)
Sponsor's past termination rate: 5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 129 (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: 1185 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 243 (typical: 412.5)
Drug's FAERS reports marked serious: 86.5% (typical: 85.6%)
Drug's FAERS reports with a death: 13.8% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: moxifloxacin

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

Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults NCT01073891 · started 2010 · scored riskier than 0% of active trials completed
Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani Subjects NCT05307614 · started 2019 · scored riskier than 0% of active trials completed
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years NCT03962062 · started 2021 · scored riskier than 17% of active trials completed
Bioequivalence Study of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects NCT04873570 · started 2021 · scored riskier than 0% of active trials completed
Pharmacokinetics of Intravenous Metamizole in Children Less Than 6 Years Old NCT02660177 · started 2016 · scored riskier than 8% 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.