search
Back to results

Effect of Lactoferrin in Pneumonia Treatment

Primary Purpose

Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactoferrin
Pneumonia treatment
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pneumonia patients
  • from the age of one month to the age of 18 years .

Exclusion Criteria:

Neonates and any children with :

  • immune deficiency
  • congenital heart disease
  • neuromascular disorder
  • genetic syndromes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Patients with pneumonia who receive only treatment for pneumonia

    pneumonia patients receive treatment for pneumonia and lactoferrin

    Arm Description

    They receive only treatment for pneumonia

    They receive treatment for pneumonia and lactoferrin

    Outcomes

    Primary Outcome Measures

    Survival rate.
    Comparing the influence of the intervention on the Survival rate.

    Secondary Outcome Measures

    Mean change in the disease severity (clinical assessment)
    Recording the changes from severe to moderate or mild and the time taken

    Full Information

    First Posted
    March 12, 2022
    Last Updated
    June 18, 2022
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05431023
    Brief Title
    Effect of Lactoferrin in Pneumonia Treatment
    Official Title
    Efficacy of Lactoferrin as Adjunct Therapy for Pneumonia in Children and Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Pneumonia is defind as the inflammation of lung tissue caused by an infectious agent that results in acute respiratory signs and symptoms. Community acquired pneumonia (CAP) is a major cause of morbidity and increased health care costs. In developing nations, pneumonia remains a significant cause of mortality in children. Pneumonia occurs in 30 to 45 of every 1,000 children under 5 years of age; it is less common in 5- to 9-year olds (16 to 22/1,000) and in older children (7 to 16/1,000). Streptococcus pneumoniae is the primary bacterial cause of pneumonia in infants and children. Viral etiologies become less prevalent and mycoplasmal and chlamydial infections become more prevalent with increasing age
    Detailed Description
    Lactoferrin (LF) is iron-binding glycoprotein of the transferrin family that is expressed and secreted by glandular cells and is found in most body fluids . It appears at especially high concentrations in mammalian milk and was first identified in bovine milk , and was subsequently isolated from human milk. LFs bacteriostatic function is due to its ability to take up the Fe3+ ion, limiting use of this nutrient by bacteria at the infection site and inhibiting the growth of these microorganisms as well as the expression of their virulence factors .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with pneumonia who receive only treatment for pneumonia
    Arm Type
    Experimental
    Arm Description
    They receive only treatment for pneumonia
    Arm Title
    pneumonia patients receive treatment for pneumonia and lactoferrin
    Arm Type
    Experimental
    Arm Description
    They receive treatment for pneumonia and lactoferrin
    Intervention Type
    Drug
    Intervention Name(s)
    Lactoferrin
    Intervention Description
    Lactoferrin binds to and blocks glycosaminoglycan viral receptors, especially heparan sulfate (HS). The binding of LF and HS prevents the first contact between virus and host cell and therefore prevents the infection
    Intervention Type
    Drug
    Intervention Name(s)
    Pneumonia treatment
    Intervention Description
    Antibiotics for pneumonia
    Primary Outcome Measure Information:
    Title
    Survival rate.
    Description
    Comparing the influence of the intervention on the Survival rate.
    Time Frame
    Up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Mean change in the disease severity (clinical assessment)
    Description
    Recording the changes from severe to moderate or mild and the time taken
    Time Frame
    Up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pneumonia patients from the age of one month to the age of 18 years . Exclusion Criteria: Neonates and any children with : immune deficiency congenital heart disease neuromascular disorder genetic syndromes

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Lactoferrin in Pneumonia Treatment

    We'll reach out to this number within 24 hrs