Mycoplasma Pneumoniae PneumoniaPhase 4NCT02618057
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
A Phase 4 study testing Prednisolone and Levofloxacin in people with Mycoplasma Pneumoniae Pneumonia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Mycoplasma Pneumoniae Pneumonia
- What is being tested?
- Prednisolone and Levofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Dec 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Evidence of Mycoplasma pneumoniae infection
- Lobar pneumonia or pneumoniae with pleural effusion
Who cannot join
- Immunosuppresant host
- Chronic cardiovascular/pulmonary disease
- Hospital acquired infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Children's Hospital
Seoul
Ki Wook Yun, Prof., 82-2-2072-4909, pedwilly@snu.ac.kr
About this study
Official title: Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.
Read the detailed description
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.
- Conditions
- Mycoplasma Pneumoniae Pneumonia
- Being tested
- Prednisolone, Levofloxacin
- Medical subject headings
- Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called Solondo
PO prednisolone, 1 mg/kg/day, for 5 days
LevofloxacinDrug
Levofloxacin, 10mg/kg/day, IV, for 5days
| Study group | Role | What they receive |
|---|---|---|
| Steroid | Experimental | Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days Receives: Drug: Prednisolone; Drug: Levofloxacin |
| Control | Active comparator | Levofloxacin, 10mg/kg/day, IV, for 5days Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever duration
Measured: within the first 14 days after intervention
Secondary outcomes (3)
Number of patients improved in chest X-ray
Measured: within the first 7 days after intervention
Number of patients with side effect of steroid
Measured: within the first 14 days after intervention
Number of patients improved in chest X-ray
Measured: within the first 14 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycoplasma Pneumoniae PneumoniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun Hwa Choi, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618057
- Sponsor's protocol ID
- SNUH_P01
- Status last verified
- Apr 2018
- First submitted
- 8 Nov 2015
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
- ClinicalTrials.gov ID
- NCT02618057
- Acronym / sponsor ID
- SNUH_P01
- Conditions
- Mycoplasma Pneumoniae Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Dec 2015 (estimated)
- 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.
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.
Detailed description
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid | Experimental | Drug: Prednisolone, Drug: LevofloxacinPrednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days |
| Control | Active comparator | Drug: LevofloxacinLevofloxacin, 10mg/kg/day, IV, for 5days |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Evidence of Mycoplasma pneumoniae infection
- Lobar pneumonia or pneumoniae with pleural effusion
Key exclusion criteria (3 listed)
- Immunosuppresant host
- Chronic cardiovascular/pulmonary disease
- Hospital acquired infection
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 |
|---|---|---|
| PrednisoloneAlso: SolondoPO prednisolone, 1 mg/kg/day, for 5 days | Drug | Steroid |
| LevofloxacinLevofloxacin, 10mg/kg/day, IV, for 5days | Drug | Control, Steroid |
Primary outcome
Fever duration
Time frame: within the first 14 days after intervention
3 secondary outcomes
Number of patients improved in chest X-ray
Time frame: within the first 7 days after intervention
Number of patients with side effect of steroid
Time frame: within the first 14 days after intervention
Number of patients improved in chest X-ray
Time frame: within the first 14 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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Pneumonia
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.
Eun Hwa Choi, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site 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 and Levofloxacin in people with Mycoplasma Pneumoniae Pneumonia, run by Seoul National University Hospital at 1 site in South Korea.
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 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 27 Apr 2018. 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 South Korea. 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.
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 Ki Wook Yun, M.D., Ph.D. (82-2-2072-4909, pedwilly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever duration (time frame: within the first 14 days after intervention). 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 27 Apr 2018.