NCT05431023

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

March 12, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

March 12, 2022

Last Update Submit

June 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival rate.

    Comparing the influence of the intervention on the Survival rate.

    Up to 8 weeks

Secondary Outcomes (1)

  • Mean change in the disease severity (clinical assessment)

    Up to 4 weeks

Study Arms (2)

Patients with pneumonia who receive only treatment for pneumonia

EXPERIMENTAL

They receive only treatment for pneumonia

Drug: Pneumonia treatment

pneumonia patients receive treatment for pneumonia and lactoferrin

EXPERIMENTAL

They receive treatment for pneumonia and lactoferrin

Drug: LactoferrinDrug: Pneumonia treatment

Interventions

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

pneumonia patients receive treatment for pneumonia and lactoferrin

Antibiotics for pneumonia

Patients with pneumonia who receive only treatment for pneumoniapneumonia patients receive treatment for pneumonia and lactoferrin

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Neonates and any children with :
  • immune deficiency
  • congenital heart disease
  • neuromascular disorder
  • genetic syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteins

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
Principal investigator

Study Record Dates

First Submitted

March 12, 2022

First Posted

June 24, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2024

Last Updated

June 24, 2022

Record last verified: 2022-06