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Trial · NCT07357103

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryHierarchical composite outcomeDay 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)
SecondaryProportion of patients that die (death)Day 30Mortality at day 30
SecondaryProportion of patients with a need for new extracorporeal membrane oxygenation (ECMO),Day 30New initiation of extracorporeal membrane oxygenation during hospitalization following initiation of assigned PCP treatment strategy.
SecondaryProportion of patients requiring new Invasive Mechanical VentilationDay 30Initiation of invasive mechanical ventilation via endotracheal intubation during hospitalization following initiation of the assigned PCP treatment strategy.
SecondaryProportion of patients with severe (CTCAE grade 4) adverse drug eventDay 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).
SecondaryProportion 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.
SecondaryProportion of patients requiring escalation or change of PCP -directed therapyDay 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.
SecondaryMedian length of stay in hospital amongst survivorsDay 30Length of hospital stay, measured in days from hospital admission to discharge among participants who survive to hospital discharge.
OtherTertiary outcome measure of quality of life at day 30Day 30Quality of life (EQ-5D-5L) wherein a higher score indicates better quality of life.
OtherTertiary outcome measure of all-cause mortalityDay 180All-cause mortality, defined as death from any cause.
OtherTertiary Outcome Measure of PCP recurrenceDay 180Recurrence of pneumocystis pneumonia, defined as a new episode of clinically and/or microbiologically confirmed PCP after initial resolution.
OtherTertiary Outcome measure of quality of life at day 180Day 180Quality 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.

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