Unresolving Pneumonia in ChildrenNCT06727188
Atypical Pneumonia
An observational study of Unresolving Pneumonia in Children, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about causes of unresolved pneumonia in children who take appropriate antimicrobial therapy. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Unresolving Pneumonia in Children
- What is being tested?
- Laboratory as cbc crp
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 2 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children included in the definition of unresolving pneumonia
Who may be able to join
- Patients with incomplete resolution by 4 weeks despite appropriate antimicrobial therapy.
- From the age of one month to the age of 6 years old.
Who cannot join
- *Age of the patient below one month and above 6 years old.
- Patients with chronic lung diseases.
- Patients with immunodeficiency.
- Patient with aspiration pneumonia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinico Laboratory Study of Unresolving Pneumonia in Children
The goal of this observational study is to learn about causes of unresolved pneumonia in children who take appropriate antimicrobial therapy.
Read the detailed description
Recurrent pneumonia is defined as two episodes of pneumonia in 1 year or three episodes over any time frame. Non resolving pneumonias are characterized by the persistence of symptoms and roentgenographic abnormalities for more than 1 month. The key step in evaluating the patient referred for recurrent or persistent pneumonia is to review the clinical and radiographic features of the episodes to determine if there is adequate documentation to proceed with treatment. After deciding that a patient has had a persistent episode of pneumonia or the requisite number of recurrent episodes of pneumonia (accompanied by radiographic evidence of pulmonary infiltrates), it is essential to classify the episodes into those involving single or multiple lobes. On the basis of this classification.
- Conditions
- Unresolving Pneumonia in Children
- Being tested
- Laboratory as cbc crp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory as cbc crpDiagnostic test
Using laboratory and imaging investigations to help in diagnosis and follow up the cases
What is being measured
The primary outcome is the main question the study is designed to answer.
studying the prevalence of unresolving pneumonia and determining the underlying ateology .
Recurrent pneumonia is defined as two episodes of pneumonia in 1 year or three episodes over any time frame. Non resolving pneumonias are characterized by the persistence of symptoms and roentgenographic abnormalities for more than 1 month. The key step in evaluating the patient referred for recurrent or persistent pneumonia is to review the clinical and radiographic features of the episodes to determine if there is adequate documentation to proceed with treatment. After deciding that a patient has had a persistent episode of pneumonia or the requisite number of recurrent episodes of pneumonia (accompanied by radiographic evidence of pulmonary infiltrates), it is essential to classify the episodes into those involving single or multiple lobes. On the basis of this classification.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresolving Pneumonia in ChildrenStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal hussein, Assiut University
- Investigators
- Maher Mokhtar Ahmed, Professor, Study director, AssiutUniversityAhlam Badawi Ali, Doctor, Study director, AssiutUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727188
- Sponsor's protocol ID
- Atypical pneumonia
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Silva GD, Lamabadusuriya SP, Abeywickrema R. Unresolving pneumonia in a child? Look for an aspirated foreign body. Ceylon Med J. 1996 Dec;41(4):159. No abstract available.
PubMed 9141762
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinico Laboratory Study of Unresolving Pneumonia in Children
- ClinicalTrials.gov ID
- NCT06727188
- Acronym / sponsor ID
- Atypical pneumonia
- Conditions
- Unresolving Pneumonia in Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 10 Dec 2024 (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.
The goal of this observational study is to learn about causes of unresolved pneumonia in children who take appropriate antimicrobial therapy.
Detailed description
Recurrent pneumonia is defined as two episodes of pneumonia in 1 year or three episodes over any time frame. Non resolving pneumonias are characterized by the persistence of symptoms and roentgenographic abnormalities for more than 1 month. The key step in evaluating the patient referred for recurrent or persistent pneumonia is to review the clinical and radiographic features of the episodes to determine if there is adequate documentation to proceed with treatment. After deciding that a patient has had a persistent episode of pneumonia or the requisite number of recurrent episodes of pneumonia (accompanied by radiographic evidence of pulmonary infiltrates), it is essential to classify the episodes into those involving single or multiple lobes. On the basis of this classification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children included in the definition of unresolving pneumonia
Key inclusion criteria (2 listed)
- Patients with incomplete resolution by 4 weeks despite appropriate antimicrobial therapy.
Key exclusion criteria (4 listed)
- *Age of the patient below one month and above 6 years old.
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 |
|---|---|---|
| Laboratory as cbc crpUsing laboratory and imaging investigations to help in diagnosis and follow up the cases | Diagnostic test | – |
Primary outcome
studying the prevalence of unresolving pneumonia and determining the underlying ateology .
Time frame: One year
Recurrent pneumonia is defined as two episodes of pneumonia in 1 year or three episodes over any time frame. Non resolving pneumonias are characterized by the persistence of symptoms and roentgenographic abnormalities for more than 1 month. The key step in evaluating the patient referred for recurrent or persistent pneumonia is to review the clinical and radiographic features of the episodes to determine if there is adequate documentation to proceed with treatment. After deciding that a patient has had a persistent episode of pneumonia or the requisite number of recurrent episodes of pneumonia (accompanied by radiographic evidence of pulmonary infiltrates), it is essential to classify the episodes into those involving single or multiple lobes. On the basis of this classification.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Results publication: PubMed 9141762de Silva GD, Lamabadusuriya SP, Abeywickrema R. Unresolving pneumonia in a child? Look for an aspirated foreign body. Ceylon Med J. 1996 Dec;41(4):159. No abstract available.
- Individual participant dataSharing planned: No
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.
Maher Mokhtar Ahmed, Professor study director
AssiutUniversity
Ahlam Badawi Ali, Doctor study director
AssiutUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresolving Pneumonia in Children, run by Assiut University at 1 site in Egypt.
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 4 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: opening soon, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Gamal Hussein, Resident doctor (800-555-5555 ext. 01060617625, yoyo74031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
studying the prevalence of unresolving pneumonia and determining the underlying ateology . (time frame: One year). 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 NCT06727188, which also lists 1 linked publication.
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 10 Dec 2024.