Severe PneumoniaPhase 4NCT05768204
Research on the Treatment of Severe Community-acquired Pneumonia in Children
A Phase 4 study testing Prednisolone Acetate in people with Severe Pneumonia, run by Baoping XU at 3 sites in China.
Trial summary
The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Severe Pneumonia
- What is being tested?
- Prednisolone Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesChina
- Study dates
- 10 Mar 2023to 1 Dec 2025
- Phase
- Phase 4
- 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
- 1 month-< 18 years old.
- Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes).
- Meet any of the following:
- (1) the general condition is very poor;
- (2) refusal to eat or dehydration;
- (3) Significantly increased respiratory rate (70 times/min > infants, 50 times/min for older children>);
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- (4) dyspnea (three concave sign, moaning, nasal flapping)
- (5) hypoxemia (cyanosis, transcutaneous oxygen saturation< 92% (not oxygenated));
- (6) Pulmonary infiltration≥ 2/3 lung or multilobar infiltration;
- (7) There is a pleural effusion;
- (8) Extrapulmonary complications
Who cannot join
- Systemic corticosteroids have been used to treat pneumonia before admission.
- Use systemic glucocorticoids within 3 months before admission.
- Hospital-acquired pneumonia.
- Children with history of tuberculosis, branch expansion, tumors, immune deficiency, congenital heart, chronic pulmonary heart disease, kidney disease, severe malnutrition, recurrent respiratory infections, congenital bronchopulmonary dysplasia (BPD) and other underlying diseases.
- Unconscious, need endotracheal intubation, children admitted to ICU.
- Those who are allergic to the drugs or their preparation components involved in the study.
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- Those with hormonal contraindications: hypertension, diabetes, active peptic ulcer, adrenal hyperfunction, corneal ulcer, increased intraocular pressure, severe psychosis.
- There is a current infection that is difficult to control with antibacterial drugs.
- Children who are participating in other clinical trials.
- The investigator believes that it is not suitable to participate in the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Baoding Children's Hospital
Baoding
he zhang, master
- Recruiting
Beijing Children's Hospital
Beijing
yongkang wang, bachelor
- Recruiting
Beijing Fangshan District Health Care Hospital
Beijing
jianxin He, doctor
About this study
The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia.
Read the detailed description
The use of glucocorticoid for severe community-acquired pneumonia in children is still controversial in clinic. There is still a lack of high quality clinical research results in this field. That's the purpose of this study. The study used oral glucocorticoids and placebos. It was a multicenter clinical study involving 160 people. The enrolled subjects were treated for 5 days after basic assessment, and the use of experimental drugs and changes in clinical manifestations and laboratory examination were strictly recorded. The possible adverse hormonal reactions such as hyperglycemia, hypertension and gastrointestinal ulcer bleeding should be closely monitored and appropriate treatment measures should be taken in time. Subject will be allowed to terminate the test if necessary. Record and discuss similar events. The double blind principle is strictly observed during the experiment to ensure the authenticity and reliability of the experimental data.
- Conditions
- Severe Pneumonia
- Being tested
- Prednisolone Acetate, placebo
- Keywords
- Severe pneumonia, children, glucocorticoid, Randomized Controlled Trial
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone AcetateDrug
Also called Prednisolone
The experimental group took prednisolone acetate which is a kind of oral glucocorticoid.
placeboOther
A placebo consistent in appearance with the prednisolone acetate.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Prednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days. Receives: Drug: Prednisolone Acetate |
| Placebo group | Placebo comparator | The same amount of placebo was taken orally as the trial for 5 days Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of early treatment success
temperature is normal, clinical manifestations are significantly improved, pulmonary signs are significantly improved or disappeared, and white blood cell\C reactive protein\procalcitonin returns to normal
Measured: third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start10 Mar 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baoping XU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baoping XU, Beijing Children's Hospital
- Investigators
- Baoping Xu, Study director, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768204
- Sponsor's protocol ID
- BCH lung 020
- Status last verified
- Mar 2023
- First submitted
- 20 Dec 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Treatment of Severe Community-acquired Pneumonia in Children
- ClinicalTrials.gov ID
- NCT05768204
- Acronym / sponsor ID
- BCH lung 020
- Conditions
- Severe Pneumonia
- Keywords
- Severe pneumonia, children, glucocorticoid, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Baoping XUUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 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.
The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia.
Detailed description
The use of glucocorticoid for severe community-acquired pneumonia in children is still controversial in clinic. There is still a lack of high quality clinical research results in this field. That's the purpose of this study. The study used oral glucocorticoids and placebos. It was a multicenter clinical study involving 160 people. The enrolled subjects were treated for 5 days after basic assessment, and the use of experimental drugs and changes in clinical manifestations and laboratory examination were strictly recorded. The possible adverse hormonal reactions such as hyperglycemia, hypertension and gastrointestinal ulcer bleeding should be closely monitored and appropriate treatment measures should be taken in time. Subject will be allowed to terminate the test if necessary. Record and discuss similar events. The double blind principle is strictly observed during the experiment to ensure the authenticity and reliability of the experimental data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Prednisolone AcetatePrednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days. |
| Placebo group | Placebo comparator | Other: placeboThe same amount of placebo was taken orally as the trial for 5 days |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 1 month-< 18 years old.
- Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes).
- Meet any of the following:
Key exclusion criteria (10 listed)
- Systemic corticosteroids have been used to treat pneumonia before admission.
- Use systemic glucocorticoids within 3 months before admission.
- Hospital-acquired pneumonia.
- Children with history of tuberculosis, branch expansion, tumors, immune deficiency, congenital heart, chronic pulmonary heart disease, kidney disease, severe malnutrition, recurrent respiratory infections, congenital bronchopulmonary dysplasia (BPD) and other underlying diseases.
- Unconscious, need endotracheal intubation, children admitted to ICU.
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 |
|---|---|---|
| Prednisolone AcetateAlso: PrednisoloneThe experimental group took prednisolone acetate which is a kind of oral glucocorticoid. | Drug | Experimental group |
| placeboA placebo consistent in appearance with the prednisolone acetate. | Other | Placebo group |
Primary outcome
the rate of early treatment success
Time frame: third day
temperature is normal, clinical manifestations are significantly improved, pulmonary signs are significantly improved or disappeared, and white blood cell\C reactive protein\procalcitonin returns to normal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Baoping Xu study director
Beijing Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone Acetate in people with Severe Pneumonia, run by Baoping XU at 3 sites in China.
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 11 inclusion and 10 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Baoping Xu (13370115002, xubaopingbch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of early treatment success (time frame: third day). 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 14 Mar 2023.