Reason Evaluation of Initial Treatment Failure in Patients With CAP

NCT03280004 | Unknown FDA Drug

• 1 other identifier: HS-1279
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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 early deterioration or progression on the prognosis of community acquired pneumonia.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• early deterioration or progression rate

  3 days

Study Arms (2)

Moxifloxacin group

Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection

β-lactams group

Interventions

Moxifloxacin Hydrochloride and Sodium Chloride Injection 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.

Moxifloxacin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Jun Xu

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Moxifloxacin; Sodium Chloride

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Xuezhong Yu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Xu, MD

CONTACT

010-69159142; xujunfree@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 12, 2017
• Study Start: November 20, 2017
• Primary Completion: August 31, 2019
• Study Completion: November 30, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)