Trial · NCT05101187
Olorofim Aspergillus Infection Study
NCT05101187, Phase 3, Completed, F2G Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Olorofim Aspergillus Infection Study. Trials, record NCT05101187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05101187
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olorofim Aspergillus Infection Study
- NCT number
- NCT05101187
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 225 participants, actual
- Lead sponsor
- F2G Ltd
- Conditions
- Invasive Aspergillosis
- Interventions
- Olorofim, AmBisome®
- First posted
- 2021-11-01
- Last updated
- 2026-10-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause mortality | Treatment Day 42 | To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) Aspergillus species (invasive aspergillosis, IA). |
| Secondary | Adjudicated Assessment of Overall outcome | Day 42, Day 84, and End of Treatment (anytime during the study between first administration and Day 84) | To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Data Review Committee (DRC)-adjudicated assessment of overall outcome in patients with proven IA or probable LRTD IA at Day 42, Day 84, and End of Treatment. |
| Secondary | Investigator-assessed overall response | Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]), and 4-week Follow-up (FU). | Investigator-assessed overall response (integrating clinical, radiological, and mycological response). |
| Secondary | To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Galactomannan index. | Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) and 4-week Follow-up (FU) | The Sponsor's expert advisors suggested that an appropriate rule would be a failure of the GM to decline from baseline. The experts also state that they have seen very significant variation on retesting of both BAL and serum GM samples and believe it is more appropriate to state a fixed reduction of ≥ 1.0 units than any percentage reduction. These rules are used for changes in GM that document failure of therapy: 1. Serum: After 8 or more days of treatment, serum GM has neither (1) fallen by ≥ 1 unit nor (2) to \< 0.5 based on measurements taken at least 8 days apart. 2. BAL: After 8 or more days of treatment, positive GM from BAL in a patient with a previous BAL test that did not meet the definition of positive (too low or entirely negative) without regard for the interval of time between samples. |
| Secondary | To collect additional olorofim and the disproportionate metabolite H26C pharmacokinetic (PK) data for inclusion in a Population PK model | Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 70, Day 84, and at EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) | To collect plasma concentration of olorofim and H26C metabolic for for PK analysis (pre-dose and intensive PK). No non-compartmental PK analysis will be performed on the data relating to pre-dose samples and intensive PK samples, apart from data collected from selected regions, which will be reported separately. All relevant olorofim data will be provided to support population PK modelling, which will be reported separately. |
| Secondary | Data Review Committee's Assessment of Patient Mortality | Day 42 and 84 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) | Study data will be independently assessed by a blinded DRC consisting of independent experts in the diagnosis and management of IA, providing an independent adjudication of each patient's mortality based on the survival status collect at time frame. |
| Secondary | Diagnosis of a secondary fungal infection | at any time through End Of Treatment | To compare incidence of a secondary fungal infection when patients treated with olorofim versus treatment with AmBisome followed by SOC. |
| Secondary | Quality of life as measured by the 5 Level 5 Dimension (EQ-5D-5L) at Baseline | Days 14 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) | To assess patient's quality of life measured by the 5-Level 5-Dimension EuroQol Group Health-related Quality of Life Questionnaire (EQ-5D-5L) in both treatment groups |
| Secondary | Survival status | Day 42, Day 84, and End Of Treatment and at the 4 weeks ± 7 days FU | All-cause mortality will be assessed using survival status at time frame. |
| Secondary | Safety Assessment | up to the Day 84 and 4-week Follow-up (FU) | To monitor incidence of Adverse Events and Serious Adverse Events in both treatment arms (Olorofim or AmBisome followed by Standard of Care). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42446237 | DERIVED |
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/NCT05101187
GET https://conductscience.org/api/trials/v1/NCT05101187/registered