Reason Evaluation of Initial Treatment Failure in Patients With CAP

Community-acquired Pneumonia Clinical Trial

— RECAP  

Official title:

Reason Evaluation of Initial Treatment Failure in Patients With Community Acquired Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03280004
• Other study ID #: HS-1279
• Status: Recruiting
• Start date: November 20, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2019
• Source: Peking Union Medical College Hospital
• Contact: Jun Xu, MD
• Phone: 010-69159142
• Email: xujunfree[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: November 30, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age>=18y.

2. Diagnosed with CAP.

3. Need hospitalization.

4. Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or ß-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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Moxifloxacin Hydrochloride and Sodium Chloride Injection
Moxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and ß-lactams group will be given ß-lactam antibiotics for injection +/- Azithromycin for Injection.

Locations

Country	Name	City	State
China	Jun Xu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early deterioration or progression rate		3 days