NCT04531332

Brief Summary

The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

July 30, 2020

Last Update Submit

September 10, 2021

Conditions

Pneumonia

Keywords

linezolid continuous infusionpneumoniacritically ill patients

Outcome Measures

Primary Outcomes (2)

  • Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group

    The primary efficacy endpoint will be evaluated as clinical cure on day 7 of Linezolid initiation. Clinical cure defined by normalized body temperature, TLC less than 10,000/mL, absence of purulent secretions, and improvement of radiological findings (x-ray), in addition to Pao2/Fio2 greater than 250 in patients.

    through study completion, over one year

  • Percentage of occurrence of anemia and thrombocytopenia

    The patients' hematological parameters (hemoglobin (Hb), hematocrit (Hct), and platelets (PLTs) counts) will be compared every 2 days during linezolid treatment between two groups. Anemia is defined as decrease in hemoglobin level \<10 g/dl and Thrombocytopenia is defined as decrese in platelets count \<100 × 103/mm3

    through study completion, over one year

Study Arms (2)

Continuous infusion

EXPERIMENTAL

Patients will be received linezolid 600 mg intravenous Loading dose over 30 to 60 minutes followed by 1200 mg/ day by Continuous infusion (50 mg /hr)

Drug: Continuous infusion Linezolid

Intermittent dosing

ACTIVE COMPARATOR

Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes

Drug: intermittent dosing linezolid

Interventions

Continuous infusion LinezolidDRUG

Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )

Also known as: intervention
Continuous infusion
intermittent dosing linezolidDRUG

Linezolid 600 mg intravenous twice daily

Also known as: control
Intermittent dosing

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAdult, Older Adult
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to ICUs diagnosed as HAP or VAP
  • Chest X-ray/ computed tomography showing new or progressive infiltrate.
  • New onset of purulent sputum or change in sputum character.
  • Body temperature greater than 38 ℃ or less than 35.5℃.
  • White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.
  • Significant quantitative pathogen cultures from respiratory secretions.

You may not qualify if:

  • Age \<18 years, Pregnancy, Lactation
  • Previous known allergic reaction to linezolid
  • Creatinine Clearance (CrCl) \<10 mL/min, calculated according to the Cockcroft-Gault formula
  • Thrombocytopenia (platelet count less than 80,000/mm3)
  • Severe hepatic failure (Child-Pugh C)
  • Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)
  • Acute DIC score \> 4 points or hematological disorder
  • Concurrent drug-associated Thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef University

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

Methods

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ahmed Essam, BSc

    October 6 University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed E Abou warda, BSc

CONTACT

00201007647696ahmed.essam@o6u.edu.eg

Rania M Sarhan, PhD

CONTACT

0021008789509

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 28, 2020

Study Start

November 15, 2019

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)