PneumoniaNCT05431023
Effect of Lactoferrin in Pneumonia Treatment
A study testing Lactoferrin and Pneumonia treatment in people with Pneumonia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Lactoferrin and Pneumonia treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pneumonia patients
- from the age of one month to the age of 18 years .
Who cannot join
- Neonates and any children with :
- immune deficiency
- congenital heart disease
- neuromascular disorder
- genetic syndromes
About this study
Official title: Efficacy of Lactoferrin as Adjunct Therapy for Pneumonia in Children and Adolescents
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
Read the 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 .
- Conditions
- Pneumonia
- Being tested
- Lactoferrin, Pneumonia treatment
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDrug
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 treatmentDrug
Antibiotics for pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Patients with pneumonia who receive only treatment for pneumonia | Experimental | They receive only treatment for pneumonia Receives: Drug: Pneumonia treatment |
| pneumonia patients receive treatment for pneumonia and lactoferrin | Experimental | They receive treatment for pneumonia and lactoferrin Receives: Drug: Lactoferrin; Drug: Pneumonia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate.
Comparing the influence of the intervention on the Survival rate.
Measured: Up to 8 weeks
Secondary outcomes (1)
Mean change in the disease severity (clinical assessment)
Recording the changes from severe to moderate or mild and the time taken
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omima mahran hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431023
- Sponsor's protocol ID
- Pneumonia
- Status last verified
- Jun 2022
- First submitted
- 12 Mar 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactoferrin as Adjunct Therapy for Pneumonia in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05431023
- Acronym / sponsor ID
- Pneumonia
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pneumonia who receive only treatment for pneumonia | Experimental | Drug: Pneumonia treatmentThey receive only treatment for pneumonia |
| pneumonia patients receive treatment for pneumonia and lactoferrin | Experimental | Drug: Lactoferrin, Drug: Pneumonia treatmentThey receive treatment for pneumonia and lactoferrin |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pneumonia patients
- from the age of one month to the age of 18 years .
Key exclusion criteria (5 listed)
- immune deficiency
- congenital heart disease
- neuromascular disorder
- genetic syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactoferrinLactoferrin 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 | Drug | pneumonia patients receive treatment for pneumonia and lactoferrin |
| Pneumonia treatmentAntibiotics for pneumonia | Drug | Patients with pneumonia who receive only treatment for pneumonia, pneumonia patients receive treatment for pneumonia and lactoferrin |
Primary outcome
Survival rate.
Time frame: Up to 8 weeks
Comparing the influence of the intervention on the Survival rate.
1 secondary outcome
Mean change in the disease severity (clinical assessment)
Time frame: Up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin and Pneumonia treatment in people with Pneumonia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate. (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.