Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial

NCT05764746 on ClinicalTrials.gov Phase 2/3 Muhimbili University of Health and Allied Sciences (academic or other) Started 2023-05-01 Completed

Riskier than 14% of active trials

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (81 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2025-01-01, after 2023-05-01 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 2025-01-01. 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: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: severenewtherapyhoursacute
Phrases that lowered it: childrentrialdayefficacyand safety
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 0.5 (lowers risk) · Who can join
Responsible party: principal investigator (lowers risk) · Design
Drug's FAERS reports marked serious: 97.3% (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: 10.4% (lowers risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Phase: 2/3 (raises risk) · Design
Collaborators: 2 (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Blinding: double (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: 2/3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 2 (typical: 0)
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 0.5 (typical: 18)
Maximum age: 10 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 7 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 490 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 51 (typical: 412.5)
Drug's FAERS reports marked serious: 97.3% (typical: 85.6%)
Drug's FAERS reports with a death: 10.4% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: amodiaquine, artemether lumefantrine, artesunate

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

A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs. NCT03923725 · started 2020 · scored riskier than 14% of active trials completed
Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children NCT01082705 · started 2010 · scored riskier than 24% of active trials completed
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia) NCT03939104 · started 2021 · scored riskier than 14% of active trials completed
A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC) NCT02453308 · started 2015 · scored riskier than 17% of active trials completed
Artemisinin-Based Antimalarial Combinations and Clinical Response in Cameroon NCT01845701 · started 2010 · scored riskier than 12% 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.