Reason Evaluation of Initial Treatment Failure in Patients With CAP (RECAP)

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: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection

• Study Type: Observational
• Enrollment (Anticipated): 314

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Jun Xu
      • Contact: Jun Xu, MD; Phone Number: 01069159142 01069159142; Email: xujunfree@126.com

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moxifloxacin group	Drug: 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.
β-lactams group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
early deterioration or progression rate	3 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Xuezhong Yu, MD, Peking Union Medical College Hospital

Study record dates

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