Effect of Lactoferrin in Pneumonia Treatment

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Efficacy of Lactoferrin as Adjunct Therapy for Pneumonia in Children and Adolescents

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Lactoferrin
* Drug: Pneumonia treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with pneumonia who receive only treatment for pneumonia<br>They receive only treatment for pneumonia | Drug: Pneumonia treatment<br>* Antibiotics for pneumonia<br>|
| Experimental: pneumonia patients receive treatment for pneumonia and lactoferrin<br>They receive treatment for pneumonia and lactoferrin | Drug: Lactoferrin<br>* 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<br>Drug: Pneumonia treatment<br>* Antibiotics for pneumonia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate. | Comparing the influence of the intervention on the Survival rate. | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the disease severity (clinical assessment) | Recording the changes from severe to moderate or mild and the time taken | Up to 4 weeks |