Community-acquired PneumoniaRECAPNCT03280004
Reason Evaluation of Initial Treatment Failure in Patients With CAP
An observational study of Community-acquired Pneumonia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for Injection) on the early deterioration or progression (<72 h of treatment) of community acquired pneumonia and to study the effect of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Moxifloxacin Hydrochloride and Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2017to 30 Nov 2019
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients in the 17 centers of the study who meet the inclusion and exclusion criteria will be included.
Who may be able to join
- Age>=18y.
- Diagnosed with CAP.
- Need hospitalization.
- Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam antibiotics for injection +/- Azithromycin for Injection as initial treatment.
- Signed informed consent form.
Who cannot join
- Patients who meet any of the following criteria will not be included in the study:
- Pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission.
- Start antibiotic treatment before admission.
- Gestational period or suckling period.
- Admitted to ICU.
- Immunocompromised patients.
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- Pneumonia is the terminal event of a serious disease.
- Tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis.
- Allergic to the antibiotics of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jun Xu
Beijing, Beijing Municipality, 100730
Jun Xu, MD, 01069159142 ext. 01069159142, xujunfree@126.com
About this study
Official title: Reason Evaluation of Initial Treatment Failure in Patients With Community Acquired Pneumonia
This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for Injection) on the early deterioration or progression (<72 h of treatment) of community acquired pneumonia and to study the effect of the early deterioration or progression on the prognosis of community acquired pneumonia.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Moxifloxacin Hydrochloride and Sodium Chloride Injection
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin Hydrochloride and Sodium Chloride InjectionDrug
Moxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and β-lactams group will be given β-lactam antibiotics for injection +/- Azithromycin for Injection.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin group | Not described Receives: Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection | |
| β-lactams group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
early deterioration or progression rate
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start20 Nov 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 314 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Xu, Peking Union Medical College Hospital
- Investigators
- Xuezhong Yu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280004
- Sponsor's protocol ID
- HS-1279
- Acronym
- RECAP
- Status last verified
- Apr 2019
- First submitted
- 10 Sep 2017
- Last updated
- 29 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reason Evaluation of Initial Treatment Failure in Patients With Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT03280004
- Acronym / sponsor ID
- RECAP / HS-1279
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 12 Sep 2017 (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.
This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for Injection) on the early deterioration or progression (<72 h of treatment) of community acquired pneumonia and to study the effect of the early deterioration or progression on the prognosis of community acquired pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin group | – | Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection |
| β-lactams group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in the 17 centers of the study who meet the inclusion and exclusion criteria will be included.
Key inclusion criteria (5 listed)
- Age>=18y.
- Diagnosed with CAP.
- Need hospitalization.
- Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam antibiotics for injection +/- Azithromycin for Injection as initial treatment.
- Signed informed consent form.
Key exclusion criteria (9 listed)
- Pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission.
- Start antibiotic treatment before admission.
- Gestational period or suckling period.
- Admitted to ICU.
- Immunocompromised patients.
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 |
|---|---|---|
| Moxifloxacin Hydrochloride and Sodium Chloride InjectionMoxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and β-lactams group will be given β-lactam antibiotics for injection +/- Azithromycin for Injection. | Drug | Moxifloxacin group |
Primary outcome
early deterioration or progression rate
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- 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.
Xuezhong Yu, MD principal investigator
Peking Union Medical College Hospital
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 Community-acquired Pneumonia, run by Peking Union Medical College Hospital at 1 site 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 5 inclusion and 9 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 29 Apr 2019. 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 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. 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 Jun Xu, MD (010-69159142, xujunfree@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early deterioration or progression rate (time frame: 3 days). 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 29 Apr 2019.