NCT03216642

Brief Summary

An observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

July 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2018

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

July 7, 2017

Last Update Submit

July 26, 2017

Conditions

DacryocystitisBacteriology

Keywords

DacryocystitisBacteriologyMicrobial Sensitivity Tests

Outcome Measures

Primary Outcomes (1)

  • Bacterial agents

    Specimens will be collected after irrigation of the lacrimal passage and be sent for bacterial culture and bacterial analysis.

    2 weeks

Secondary Outcomes (3)

  • Sensitivity test

    2 weeks

  • The colour of lacrimal sac secretion

    2 weeks

  • The character of lacrimal sac secretion

    2 weeks

Interventions

bacterial culture and analysisDIAGNOSTIC_TEST

Specimens were collected with soft-tipped applicators of sterile cotton swabs after syphilis of lacrimal passages.

Also known as: antibiotic susceptibility

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted among patients with chronic dacryocystitis attending Zhongshan Ophthalmic Center.

You may qualify if:

  • Diagnosed with chronic dacryocystitis
  • No involvement in other drug experiment in the past 1 week

You may not qualify if:

  • Can not cooperate the specimen collection
  • With any other eye disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Secretions from the lacrimal punctum

MeSH Terms

Conditions

Dacryocystitis

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Zhang Xiulan, M.D.

CONTACT

02087335367zhangxl2@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cornea department chief

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 13, 2017

Study Start

July 17, 2017

Primary Completion

April 17, 2018

Study Completion

April 17, 2018

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

CN(1)