Infant TB Infection Prevention Study
Model scores of the 29,894 trials active now.
Model score 5% 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 13% of the time (331 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-12-31, after 2016-08-31 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 2020-12-31. 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
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: infantscontrolledrandomizedtrialprevent
Phrases that lowered it: in hivhiv infectedtuberculosiskgcriteria hiv -
Phase: 2 (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Minimum age: 0.12 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 104 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 16.8% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor's past trials: 360 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past termination rate: 7.5% (raises risk) · Sponsor's track record
-
Disease area, infectious disease: Yes (lowers risk) · Disease area
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Collaborators: 1 (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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 0.12 (typical: 18)
- Maximum age
- 0.19 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 360 (typical: 32)
- Sponsor's past termination rate
- 7.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 104 (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
- 6612 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1114 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- isoniazid
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
- Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda NCT02606526 · started 2016 · scored riskier than 4% of active trials completed
- Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia NCT03915366 · started 2020 · scored riskier than 17% of active trials completed
- Study to Improve Survival Among HIV-Exposed Infants in Botswana NCT01229761 · started 2011 · scored riskier than 30% of active trials completed
- Safety and Immunogenicity of MVA85A Prime and Bacille Calmette-Guerin Boost Vaccination NCT01650389 · started 2012 · scored riskier than 6% of active trials completed
- Comparison of Efficacy and Safety of Infant Peri-exposure Prophylaxis With Lopinavir/Ritonavir Versus Lamivudine to Prevent HIV-1 Transmission by Breastfeeding NCT00640263 · started 2009 · 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.