Trial · NCT03604705
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
NCT03604705, Phase 2, Completed, Basilea Pharmaceutica; results first posted 2021-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia. Trials, record NCT03604705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03604705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
- NCT number
- NCT03604705
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Basilea Pharmaceutica
- Conditions
- Candidemia
- Interventions
- APX001
- First posted
- 2018-07-27
- Last updated
- 2025-09-16
- Results first posted
- 2021-08-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC) | One to forty-two days | Treatment Success is defined as meeting all of the following criteria: Two consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment |
| Secondary | Time to First Negative Blood Culture | One to forty-nine days | Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-Baseline negative blood culture + 1. Patients without a negative blood culture at post-Baseline visits were censored at the last assessment date. |
| Secondary | Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT) | |
| Secondary | Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | 2 and 4 weeks after end of treatment (EOT) | |
| Secondary | Overall Survival at Study Day 30 | Day 30 | |
| Secondary | Number of Patients With Treatment Emergent Adverse Events (TEAEs) | One to forty-nine days |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC) | One to forty-two days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to First Negative Blood Culture | One to forty-nine days | Days | MEAN | |
| SECONDARY | Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | 2 and 4 weeks after end of treatment (EOT) | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival at Study Day 30 | Day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Treatment Emergent Adverse Events (TEAEs) | One to forty-nine days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC) | Treatment Period - MITT | 16 | Participants | ||
| Time to First Negative Blood Culture | MITT Population | 2.4 | Standard Deviation 1.13 | Days | |
| Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | EOST (End of Study Drug Treatment) | 16 | Participants | ||
| Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | EOT (End of Antifungal Treatment) | 15 | Participants | ||
| Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | Follow-up 2 Weeks After EOT | 1 | Participants | ||
| Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | Follow-up 4 Weeks After EOT | 0 | Participants | ||
| Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | Treatment Success 2 Weeks After EOT | 60.0 | percentage of participants | ||
| Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT) | Treatment Success 4 Weeks After EOT | 55.0 | percentage of participants | ||
| Overall Survival at Study Day 30 | MITT Population | 17 | Participants | ||
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) | Safety Population | 20 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | APX001 Treatment | 21 | |
| Overall Study | COMPLETED | APX001 Treatment | 20 | |
| Overall Study | NOT COMPLETED | APX001 Treatment | 1 |
Source ClinicalTrials.gov
Adverse events29
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bacteraemia | Infections and infestations | Safety Population | 2 | 21 | 2 |
| other | Septic shock | Infections and infestations | Safety Population | 2 | 21 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Safety Population | 3 | 21 | 3 |
| other | Vomiting | Gastrointestinal disorders | Safety Population | 3 | 21 | 3 |
| other | Nausea | Gastrointestinal disorders | Safety Population | 2 | 21 | 2 |
| other | Oedema peripheral | General disorders | Safety Population | 3 | 21 | 3 |
| other | Pyrexia | General disorders | Safety Population | 2 | 21 | 2 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Safety Population | 3 | 21 | 3 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Safety Population | 2 | 21 | 2 |
| other | Acute kidney injury | Renal and urinary disorders | Safety Population | 2 | 21 | 2 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Population | 5 | 21 |
| Total, other adverse events | Safety Population | 20 | 21 |
| Total, serious adverse events | Safety Population | 9 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37596890 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03604705
GET https://conductscience.org/api/trials/v1/NCT03604705/events?page=2