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
About this trial
This is an interventional treatment trial for Pneumonia
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
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
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
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