- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03280004
Reason Evaluation of Initial Treatment Failure in Patients With CAP (RECAP)
April 26, 2019 updated by: Jun Xu, Peking Union Medical College Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
314
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Xu, MD
- Phone Number: 010-69159142
- Email: xujunfree@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Jun Xu
-
Contact:
- Jun Xu, MD
- Phone Number: 01069159142 01069159142
- Email: xujunfree@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients in the 17 centers of the study who meet the inclusion and exclusion criteria will be included.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Moxifloxacin group
|
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.
|
β-lactams group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
early deterioration or progression rate
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xuezhong Yu, MD, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2017
Primary Completion (Anticipated)
August 31, 2019
Study Completion (Anticipated)
November 30, 2019
Study Registration Dates
First Submitted
September 10, 2017
First Submitted That Met QC Criteria
September 10, 2017
First Posted (Actual)
September 12, 2017
Study Record Updates
Last Update Posted (Actual)
April 29, 2019
Last Update Submitted That Met QC Criteria
April 26, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
Other Study ID Numbers
- HS-1279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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