Complicated Pneumonia in PediatricsNCT05792904
Factors Associated With Complicated Pneumonia in Paedatrics
An observational study of Complicated Pneumonia in Pediatrics, run by Assiut University.
Trial summary
Detecting Factors associated with complicated pneumonia in pediatrics Read more about this study
- Who is it for?
- Ages 2 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Complicated Pneumonia in Pediatrics
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Apr 2024
- Phase
- Observational
- 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 2 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients included in the study will be divided into 3 groups Group1:patient with un complicated pneumonia. Group 2:patient who arrived with complicated pneumonia. Group3:patient who deveLoped pneumonia at hospital.
Who may be able to join
- Patient admitted at AUCH aged 2months up to 16 years old with sign and synptoms suggestive of pneumonia.
Who cannot join
- Immunodefiecency
- Hematological And Malignancy.
- NEONATAL PEROID.
Trial locations and contacts
No sites are listed yet.
About this study
Detecting Factors associated with complicated pneumonia in pediatrics
Read the detailed description
Community acquired pneumonia is the cause of morbidity and mortality in children worldwide ,complication of Community acquired pneumonia in paedatrics include para -pneumonic pleural effusion ,empyema, necrotizing pneumonia and lung abscess.( Sawicki GS,2008) Pediatric para-pneumonic pleural effusion and empyema are considered different stages of the same pathophysiological process in which pleural inflammation causes fluid to accumulate in the pleural cavity, Necrotizing pneumonia results from pulmonary necrosis and tissue liquefaction. ( Ira Erlichman, MD,2017) Recent reports have characterized the clinical presentation of this complication and have shown favorable outcomes in children.( Sawicki GS,2008) Complicated pneumonia was defined as clinical pneumonia and the presence of pleural effusion, empyema (EMP) or Para-pneumonic childhood EMP was defined as the presence of pus (purulent fluid and/or WBC count>5,000 permm3) or bacteria in the pleural fluid.
PPE was defined by pleural fluid not fitting criteria of EMP and the diagnosis of NP was made by the presence of multiple cavity gas-filled spaces within a pulmonary consolidation on chest X-rays or liquefaction of lung tissue according to CT scans as reviewed by a pediatric radiologist .( Ira Erlichman, MD 2017) Among patients with pneumonia AS MANY AS half may develop pleural effusions (i.e., fluid in THE PLEURAL SPACE); of these, 5-10 % MAY DEVELOP EMPYEMAN Ingeneral , "complicated pneumonia" refers to pneumonia accompanied by pleural effusion.( Byington CL,2010) Empyema is a serious COMPLICATIO characterized by pus and bacteria in the pleural space which may progress to necrosis, cavitation, or fistulas in the thoracic cavity. S. pneumoniae is the most common cause of complicated pneumonia in children (an M. A. Fletcher ETT 2014) Empyema among children age below 19 years in Utah (USA) (1994-2007)] and Australia(1998-2010)ranged from 0.9 to 12.5 per 100,000 (Byington CL,2010)the incidence was highest in children aged 0-4 and tend to increase over time. (Strachan RE,2013).
- Conditions
- Complicated Pneumonia in Pediatrics
What is being measured
The primary outcome is the main question the study is designed to answer.
patients will be assessed by complete blood count
Measured: Baseline
C-reactive protein level
Measured: Baseline
Chest x-ray or CT chest image
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complicated Pneumonia in PediatricsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marim Sedky Sedeek Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792904
- Sponsor's protocol ID
- Complicated pneumonia
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McIntosh K. Community-acquired pneumonia in children. N Engl J Med. 2002 Feb 7;346(6):429-37. doi: 10.1056/NEJMra011994. No abstract available.
PubMed 11832532Sawicki GS, Lu FL, Valim C, Cleveland RH, Colin AA. Necrotising pneumonia is an increasingly detected complication of pneumonia in children. Eur Respir J. 2008 Jun;31(6):1285-91. doi: 10.1183/09031936.00099807. Epub 2008 Jan 23.
PubMed 18216055Sahn SA. Diagnosis and management of parapneumonic effusions and empyema. Clin Infect Dis. 2007 Dec 1;45(11):1480-6. doi: 10.1086/522996. Epub 2007 Oct 24.
PubMed 17990232Strachan RE, Snelling TL, Jaffe A. Increased paediatric hospitalizations for empyema in Australia after introduction of the 7-valent pneumococcal conjugate vaccine. Bull World Health Organ. 2013 Mar 1;91(3):167-73. doi: 10.2471/BLT.12.109231. Epub 2012 Dec 11.
PubMed 23476089
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Complicated Pneumonia in Paedatrics
- ClinicalTrials.gov ID
- NCT05792904
- Acronym / sponsor ID
- Complicated pneumonia
- Conditions
- Complicated Pneumonia in Pediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 31 Mar 2023 (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.
Detecting Factors associated with complicated pneumonia in pediatrics
Detailed description
Community acquired pneumonia is the cause of morbidity and mortality in children worldwide ,complication of Community acquired pneumonia in paedatrics include para -pneumonic pleural effusion ,empyema, necrotizing pneumonia and lung abscess.( Sawicki GS,2008) Pediatric para-pneumonic pleural effusion and empyema are considered different stages of the same pathophysiological process in which pleural inflammation causes fluid to accumulate in the pleural cavity, Necrotizing pneumonia results from pulmonary necrosis and tissue liquefaction. ( Ira Erlichman, MD,2017) Recent reports have characterized the clinical presentation of this complication and have shown favorable outcomes in children.( Sawicki GS,2008) Complicated pneumonia was defined as clinical pneumonia and the presence of pleural effusion, empyema (EMP) or Para-pneumonic childhood EMP was defined as the presence of pus (purulent fluid and/or WBC count>5,000 permm3) or bacteria in the pleural fluid.
PPE was defined by pleural fluid not fitting criteria of EMP and the diagnosis of NP was made by the presence of multiple cavity gas-filled spaces within a pulmonary consolidation on chest X-rays or liquefaction of lung tissue according to CT scans as reviewed by a pediatric radiologist .( Ira Erlichman, MD 2017) Among patients with pneumonia AS MANY AS half may develop pleural effusions (i.e., fluid in THE PLEURAL SPACE); of these, 5-10 % MAY DEVELOP EMPYEMAN Ingeneral , "complicated pneumonia" refers to pneumonia accompanied by pleural effusion.( Byington CL,2010) Empyema is a serious COMPLICATIO characterized by pus and bacteria in the pleural space which may progress to necrosis, cavitation, or fistulas in the thoracic cavity. S. pneumoniae is the most common cause of complicated pneumonia in children (an M. A. Fletcher ETT 2014) Empyema among children age below 19 years in Utah (USA) (1994-2007)] and Australia(1998-2010)ranged from 0.9 to 12.5 per 100,000 (Byington CL,2010)the incidence was highest in children aged 0-4 and tend to increase over time. (Strachan RE,2013).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients included in the study will be divided into 3 groups Group1:patient with un complicated pneumonia. Group 2:patient who arrived with complicated pneumonia. Group3:patient who deveLoped pneumonia at hospital.
Key inclusion criteria (1 listed)
- Patient admitted at AUCH aged 2months up to 16 years old with sign and synptoms suggestive of pneumonia.
Key exclusion criteria (3 listed)
- Immunodefiecency
- Hematological And Malignancy.
- NEONATAL PEROID.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
patients will be assessed by complete blood count
Time frame: Baseline
C-reactive protein level
Time frame: Baseline
Chest x-ray or CT chest image
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Results publication: PubMed 11832532McIntosh K. Community-acquired pneumonia in children. N Engl J Med. 2002 Feb 7;346(6):429-37. doi: 10.1056/NEJMra011994. No abstract available.
- Results publication: PubMed 18216055Sawicki GS, Lu FL, Valim C, Cleveland RH, Colin AA. Necrotising pneumonia is an increasingly detected complication of pneumonia in children. Eur Respir J. 2008 Jun;31(6):1285-91. doi: 10.1183/09031936.00099807. Epub 2008 Jan 23.
- Results publication: PubMed 17990232Sahn SA. Diagnosis and management of parapneumonic effusions and empyema. Clin Infect Dis. 2007 Dec 1;45(11):1480-6. doi: 10.1086/522996. Epub 2007 Oct 24.
- Results publication: PubMed 23476089Strachan RE, Snelling TL, Jaffe A. Increased paediatric hospitalizations for empyema in Australia after introduction of the 7-valent pneumococcal conjugate vaccine. Bull World Health Organ. 2013 Mar 1;91(3):167-73. doi: 10.2471/BLT.12.109231. Epub 2012 Dec 11.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Pneumonia in Pediatrics, 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 1 inclusion and 3 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 31 Mar 2023. 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?
Contact mariam s sedek, MD (+201004781924, mailto:mariamaliismail08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients will be assessed by complete blood count (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792904, which also lists 4 linked publications.
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 31 Mar 2023.