Trial · NCT07357103
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hierarchical composite outcome | Day 30 | Hierarchical composite of Win Ratio at day 30: * death; * new extracorporeal membrane oxygenation (ECMO), * new invasive mechanical ventilation; * severe (CTCAE grade 4) adverse drug event (dermatologic, nephrologic, hematologic, neurologic, and/or endocrinologic) considered at least probable (by Leape and Bates criteria); * new non-invasive ventilation; * change of therapy (i.e., dose or agent) due to presumed treatment failure or probable adverse drug reaction (by Leape and Bates criteria); and * length of stay in hospital (amongst survivors) |
| Secondary | Proportion of patients that die (death) | Day 30 | Mortality at day 30 |
| Secondary | Proportion of patients with a need for new extracorporeal membrane oxygenation (ECMO), | Day 30 | New initiation of extracorporeal membrane oxygenation during hospitalization following initiation of assigned PCP treatment strategy. |
| Secondary | Proportion of patients requiring new Invasive Mechanical Ventilation | Day 30 | Initiation of invasive mechanical ventilation via endotracheal intubation during hospitalization following initiation of the assigned PCP treatment strategy. |
| Secondary | Proportion of patients with severe (CTCAE grade 4) adverse drug event | Day 30 | Proportion of patients with occurence of severe (CTCAE grade 4) adverse drug event (dermatologic, nephrologic, hematologic, neurologic, and/or endocrinologic) considered at least probable (by Leape and Bates criteria). |
| Secondary | Proportion of patients with need for new non-invasive ventilation; | Day 30 | initiation of non-invasive ventilation (including continuous positive airway pressure \[CPAP\] or bilevel positive airway pressure \[BiPAP\] during hospitalization following initiation of the assigned PCP treatment strategy. |
| Secondary | Proportion of patients requiring escalation or change of PCP -directed therapy | Day 30 | Proportion of patients with escalation or change of PCP -directed therapy due to inadequate clinical response, disease progression, or treatment-limiting toxicity during the treatment or follow-up period. |
| Secondary | Median length of stay in hospital amongst survivors | Day 30 | Length of hospital stay, measured in days from hospital admission to discharge among participants who survive to hospital discharge. |
| Other | Tertiary outcome measure of quality of life at day 30 | Day 30 | Quality of life (EQ-5D-5L) wherein a higher score indicates better quality of life. |
| Other | Tertiary outcome measure of all-cause mortality | Day 180 | All-cause mortality, defined as death from any cause. |
| Other | Tertiary Outcome Measure of PCP recurrence | Day 180 | Recurrence of pneumocystis pneumonia, defined as a new episode of clinically and/or microbiologically confirmed PCP after initial resolution. |
| Other | Tertiary Outcome measure of quality of life at day 180 | Day 180 | Quality of life assessed using a EQ-5D-5L questionnaire. High score indicates better quality of life. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07357103/registered