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Trial · NCT01653665

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryNeutrophil phagocytosis2 days after GMCSF/placebo administrationneutrophil phagocytic capacity will be measured as the percentage of neutrophils ingesting 2 or more zymosan particles ex vivo
Secondaryneutrophil phagocytic capacity on alternate study days0 - 9 daysMeasured on alternate days and also as 'area under the curve' over the study period
SecondaryOther measures of neutrophil function0-9 daysMay include but not limited to: ROS generation, migration capacity and apoptotic rate
SecondaryMonocyte HLA-DR expression0-9 daysAlternate days by flow-cytometry
SecondarySerum measures of inflammatory response0-9 daysMay include but not limited to: cytokine levels
SecondarySequential organ failure assessment (SOFA)up to end of study participation, a maximum of 30 days for each participant
SecondaryLength of ICU stayUp to end of participation in study, a maximum of 30 days
SecondaryIncidence of ICUAIs (Intensive care unit acquired infection)Up to end of study participation, a maximum of 30 days for each patientsAs defined by hospitals in europe link for infection control surveillance (HELICS)
SecondaryAll cause mortality30 days post randomisation
SecondaryNumber of days of mechanical ventilationUp to end of study participation, a maximum of 30 days
SecondaryBlood sample analysis0-9 days
To measure safety of study medication from blood samples, which will include measures of Full blood count, white cell count (including differential), U\&Es and LFTs, development of neutralising antibodies to GMCSF

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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