DacryocystitisNCT03216642
The Study of Bacteriology and Pathogen Drug Sensitivity of Chronic Dacryocystitis
An observational study of Dacryocystitis and Bacteriology, run by Sun Yat-sen University at 1 site in China.
Trial summary
An observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dacryocystitis, Bacteriology
- What is being tested?
- bacterial culture and analysis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2017to 17 Apr 2018
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted among patients with chronic dacryocystitis attending Zhongshan Ophthalmic Center.
Who may be able to join
- Diagnosed with chronic dacryocystitis
- No involvement in other drug experiment in the past 1 week
Who cannot join
- Can not cooperate the specimen collection
- With any other eye disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clinical Research Center
Guangzhou, Guangdong, 510000
Wang Zhichong, M.D., 02087333391, wzc001@hotmail.com
Liu Chengxiu, 02087333391, 13760787745@163.com
About this study
An observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.
Read the detailed description
For patients diagnosed with chronic dacryocystitis，we will collect the secretions after lacrimal passage irrigation, note the characters of the secretions and send the secretions for bacteria culture, analysis and pathogen drug sensitivity.
- Conditions
- Dacryocystitis, Bacteriology
- Being tested
- bacterial culture and analysis
- Keywords
- Dacryocystitis, Bacteriology, Microbial Sensitivity Tests
- Medical subject headings
- Dacryocystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacterial culture and analysisDiagnostic test
Also called antibiotic susceptibility
Specimens were collected with soft-tipped applicators of sterile cotton swabs after syphilis of lacrimal passages.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial agents
Specimens will be collected after irrigation of the lacrimal passage and be sent for bacterial culture and bacterial analysis.
Measured: 2 weeks
Secondary outcomes (3)
Sensitivity test
The drugs tested include Penicilin, Amikacin, Azithromycin, Cefoxitin, Levofloxacin，Ofloxacin, Cefuroxime and Tobramycin.
Measured: 2 weeks
The colour of lacrimal sac secretion
The colour of lacrimal sac secretion will be identified by the doctor during the irrigation of the lacrimal passage.
Measured: 2 weeks
The character of lacrimal sac secretion
The lacrimal sac secretion will be classified as mucus or pus.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start17 Jul 2017
- Primary completion17 Apr 2018 (estimated)
- Study completion17 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DacryocystitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zhichong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216642
- Sponsor's protocol ID
- 2017019
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Bacteriology and Pathogen Drug Sensitivity of Chronic Dacryocystitis
- ClinicalTrials.gov ID
- NCT03216642
- Acronym / sponsor ID
- 2017019
- Conditions
- Dacryocystitis, Bacteriology
- Keywords
- Dacryocystitis, Bacteriology, Microbial Sensitivity Tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 17 Apr 2018 (estimated)
- Study completion
- 17 Apr 2018 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.
Detailed description
For patients diagnosed with chronic dacryocystitis，we will collect the secretions after lacrimal passage irrigation, note the characters of the secretions and send the secretions for bacteria culture, analysis and pathogen drug sensitivity.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted among patients with chronic dacryocystitis attending Zhongshan Ophthalmic Center.
Key inclusion criteria (2 listed)
- Diagnosed with chronic dacryocystitis
- No involvement in other drug experiment in the past 1 week
Key exclusion criteria (2 listed)
- Can not cooperate the specimen collection
- With any other eye disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bacterial culture and analysisAlso: antibiotic susceptibilitySpecimens were collected with soft-tipped applicators of sterile cotton swabs after syphilis of lacrimal passages. | Diagnostic test | – |
Primary outcome
Bacterial agents
Time frame: 2 weeks
Specimens will be collected after irrigation of the lacrimal passage and be sent for bacterial culture and bacterial analysis.
3 secondary outcomes
Sensitivity test
Time frame: 2 weeks
The colour of lacrimal sac secretion
Time frame: 2 weeks
The character of lacrimal sac secretion
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Dacryocystitis
Active, not recruitingPhase 4
Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
RecruitingPhase 2
Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
Chronic Dacryocystitis
Not yet recruitingPhase 4
Hyaluronic Acid vs Mitomycin-C in External Dacryocystorhinostomy
Dacryocystitis
RecruitingObservational study
"My Eyes, My Light": Amar Chokh, Amar Alo
Glaucoma, Diabetic Retinopathy (DR)
RecruitingPhase 4
Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?
Epiphora, Dacryostenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dacryocystitis and Bacteriology, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Xiulan, M.D. (02087335367, zhangxl2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial agents (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.