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not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
314
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 29 studies in Community-Acquired Pneumonia with a site in China — 9 open to participants now, 9 under way, none of them phase 3. Community-Acquired Pneumonia · China.

Planned enrollment
12th of 15
314 · median 1,000
Started
2017
with 2 others
Observational
15 of 29
7 open now
Registered
13th of 29
by date
Lead sponsor
2 of 29
Peking Union Medical College Hospital

Among the 29 studies in Community-Acquired Pneumonia with a site in China, this one is the 12th largest by planned enrollment of the 15 observational ones that give a count, is one of 3 that started in 2017, is one of 15 observational ones, and was the 13th registered.

Community-Acquired Pneumonia

325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.

Browse Community-Acquired Pneumonia studies →

Open to participants now

9 of the 29 studies in Community-Acquired Pneumonia with a site in China are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 41 Community-Acquired Pneumonia studies recruiting now, 29 (71%) set no upper age limit and 9 (22%) stop at 75 or younger; 13 take children under 18; 5 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 29 studies in Community-Acquired Pneumonia with a site in China, or all of them as a file.
02

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.

03

Conditions studied

  • Community-acquired Pneumonia
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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. 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

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

    Drug pages: Moxifloxacin · Sodium Chloride

    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.

06

What researchers measure

Primary outcomes

  1. early deterioration or progression rate

    Time frame: 3 days

07

Study locations

1 of 1 sites recruiting
  • Jun Xu
    Beijing, Beijing 100730, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2017 (actual). Primary completion is estimated for Aug 2019, 21 months after the start.

Of 38 observational studies under Community-Acquired Pneumonia, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's planned 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2017
First posted
Sep 12, 2017
StartActual
Nov 20, 2017
Primary completionEst.
Aug 31, 2019
CompletionEst.
Nov 30, 2019
Last update
Apr 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03280004
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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