Status unknownNCT03280004RECAPUpdated Apr 29, 2019

Reason Evaluation of Initial Treatment Failure in Patients With CAP

An observational study in Community-acquired Pneumonia, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-29.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 314
Ages: 18 Years and older
Sex: All

Study 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 studied

Community-acquired Pneumonia

Browse trials for

Pneumonia 2,045

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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.

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 314 participants (estimated)
Target follow-up: 30 Days
Patient registry: Yes

Groups and cohorts

Moxifloxacin group
Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection
β-lactams group

Interventions

DrugMoxifloxacin 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.

What researchers measure

Primary outcomes

early deterioration or progression rate
Time frame: 3 days

Study locations

1 of 1 sites recruiting

Jun Xu
Beijing, Beijing 100730, China
- Jun Xu, MD · Contact · xujunfree@126.com · 01069159142
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03280004
Lead sponsor: Peking Union Medical College Hospital
Responsible party: Jun Xu (Dr, Peking Union Medical College Hospital) — Principal investigator
First posted: Sep 12, 2017
Start date: Nov 20, 2017
Primary completion: Aug 31, 2019 (estimated)
Completion: Nov 30, 2019 (estimated)
Last update: Apr 29, 2019

Study contacts

Jun Xu, MD

Contact

xujunfree@126.com

010-69159142

Xuezhong Yu, MD

principal investigator · Peking Union Medical College Hospital

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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