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Recombinant Human Granulocyte Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis

NCT03123666 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-02-20

No results posted yet for this study

Summary

Informed consent obtained from the patient or the patient's legal surrogate. The window for randomization and initiation of study drug infusion is 2 days from day of Admission. All further time points are relative to the day of randomization. Patients will be randomized (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of 10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects will be stratified based on Child status. Patients who fulfil the inclusion criteria will receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline nebulization). Standard medical care will be given in both limbs.

Conditions

  • Cirrhosis

Interventions

DRUG

GMCSF

GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer

OTHER

Placebo

Placebo identical to GMCSF will be given

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2020-10-19
Completion
2020-10-19

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123666 on ClinicalTrials.gov