Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

NCT01103063 on ClinicalTrials.gov Phase 3 Pfizer (industry) Started 2010-10-31 Terminated

Riskier than 11% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 10% of the time (1,463 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

Terminated on 2013-11-30, after 2010-10-31 start.

Reason given by the sponsor: “other”

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 2013-11-30. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: ventricularchronicevidenceenrollmentcardiac
Phrases that lowered it: the studyevaluatelaboratoryefficacyoral
Sponsor's past termination rate: 14.9% (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 396 (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Drug's FAERS reports with a death: 10.4% (lowers risk) · Drug's FDA history
Sponsor's past trials: 821 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 16 (raises risk) · Who can join
Collaborators: 2 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 2 (typical: 0)
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 16 (typical: 18)
Maximum age: 35 (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 821 (typical: 32)
Sponsor's past termination rate: 14.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 396 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 4 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 7543 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1780 (typical: 412.5)
Drug's FAERS reports marked serious: 84.0% (typical: 85.6%)
Drug's FAERS reports with a death: 10.4% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: azithromycin, chloroquine, pyrimethamine, sulfadoxine

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

Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa NCT01103713 · started 2011 · scored riskier than 99% of active trials terminated
Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria NCT00852423 · started 2010 · scored riskier than 25% of active trials completed
Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy NCT01054248 · started 2010 · scored riskier than 20% of active trials completed
Efficacy,Safety and Tolerability of Dihydroartemisinin-Piperaquine for Uncomplicated Malaria in Pregnancy in Ghana NCT01231113 · started 2011 · scored riskier than 21% of active trials completed
Efficacy and Safety of IPTp-DP Versus IPTp-SP in Malawi NCT03009526 · started 2017 · 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.