Reason Evaluation of Initial Treatment Failure in Patients With CAP

NCT ID: NCT03280004

Last Updated: 2019-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Community-acquired Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moxifloxacin group

Moxifloxacin Hydrochloride and Sodium Chloride Injection

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Moxifloxacin Hydrochloride and Sodium Chloride Injection

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age\>=18y.
2. Diagnosed with CAP.
3. Need hospitalization.
4. Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam antibiotics for injection +/- Azithromycin for Injection as initial treatment.
5. Signed informed consent form.

Exclusion Criteria

Patients who meet any of the following criteria will not be included in the study:

1. Pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission.
2. Start antibiotic treatment before admission.
3. Gestational period or suckling period.
4. Admitted to ICU.
5. Immunocompromised patients.
6. Pneumonia is the terminal event of a serious disease.
7. Tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis.
8. Allergic to the antibiotics of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jun Xu

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xuezhong Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jun Xu

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jun Xu, MD

Role: CONTACT

010-69159142

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jun Xu, MD

Role: primary

01069159142 ext. 01069159142

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HS-1279

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.