Retinal DetachmentNCT03479736
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
An observational study of Retinal Detachment and Achilles Tendon, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- What is being tested?
- Oral Fluoroquinolones (FQ), Other Antibiotics and Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
- Type of treatment
- Pill or oral medicine
- How many people
- 117,911 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 4 Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants with Achilles Tendon Rupture (ATR) or Retinal Detachment (RD) or Aortic Aneurysm and Dissection (AAD), and exposures to Fluoroquinolones (FQ) or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event.
Who may be able to join
- Have evidence of at least 1 instance of Achilles Tendon Rupture (ATR) or Retinal Detachment (RD) or Aortic Aneurysm and Dissection (AAD)
- Have at least 1 exposure to Fluoroquinolones or any of the other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotic
- Have at least 1 year of continuous enrollment with pharmacy benefits prior to the ATR, RD or AAD
Who cannot join
- ATR, AAD and RD cohorts:
- Participants who experience the index event while within a time-at-risk window for more than one exposure type. (The exposure types in this study include FQ as a class, amoxicillin, azithromycin, trimethoprim, trimethroprim/sulfamethoxazole, and febrile illness not treated with antibiotics. Events while within a time-at-risk window of two or more exposure types cannot be associated with any one exposure. Participants are therefore excluded from the study)
- For ATR and AAD cohorts:
- Have inherited disorders of connective tissue, specifically: Ehlers-Danlos syndrome, epidermolysis bullosa, Marfan syndrome, osteogenesis imperfecta
- Have an ATR or AAD event prior to index, during the 1-year pre-index period
- For RD cohort:
- Have cataract surgery prior to index
- Have iridotomy or iridectomy prior to index
Trial locations and contacts
1 site in 1 country.
United States1 site
Janssen Investigative Site
Titusville, New Jersey, 08560
About this study
Official title: A Self-Controlled Case Series Study of Fluoroquinolones Exposure and Collagen-related Serious Adverse Events
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotics, using a study design that minimizes the impact of confounders not usually captured in health services databases such as heredity or smoking.
- Conditions
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- Being tested
- Oral Fluoroquinolones (FQ), Other Antibiotics, Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
- Medical subject headings
- Retinal Detachment, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Fluoroquinolones (FQ)Drug
Participants will not receive any intervention as a part of this study. The FQ include all oral forms of FQ (24-hours extended release tablets, extended release tablets, oral solution, oral suspension, oral tablet, pack). The drugs included are ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin.
Other AntibioticsDrug
Participants will not receive any intervention as a part of this study. Other antibiotics include amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole.
Febrile Illness Not Treated with Antibiotics Will be Analyzed as an ExposureOther
Febrile illness not treated with antibiotics is defined as: concurrent diagnoses of viral disease with concurrent fever, and no concurrent prescription for any antibiotic during the 60-day period before and after the first date of viral disease diagnosis; or a diagnosis of influenza with no concurrent inpatient admission during the 60-day period pre- or post-influenza diagnosis, and no prescription for any antibiotics during the 60-day period pre- or post-influenza diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Participants with Achilles Tendon Rupture (ATR) | Participants will be defined as having ATR if they receive a diagnosis for ATR as well as one of the following procedures: tenotomy or primary ruptured Achilles Tendon (AT) repair (with or without graft) within 7 days of diagnosis. Index will be based on the earlier date of diagnosis or procedure. Participants with ATR, and exposures to Fluoroquinolone (FQ) or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event will be included. It will use data from 3 databases, which are Truven CCAE and Medicare (Supplemental) and Optum ClinFormatics (Optum). Receives: Drug: Oral Fluoroquinolones (FQ); Drug: Other Antibiotics; Other: Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure | |
| Cohort 2: Participants with Retinal Detachment (RD) | Participants will be defined as having a RD if they received a diagnosis of RD and a procedure for RD, e.g.: sclera buckle, vitrectomy, retinopexy, retinal cryotherapy, silicone oil fill, air gas fluid exchange or pneumatic retinopexy, within 14 days of index. Index will be defined as the earlier date of diagnosis or procedure. Participants with RD, and exposures to FQ or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event will be included. It will use data from 3 databases, which are Truven CCAE and Medicare (Supplemental) and Optum ClinFormatics (Optum). Receives: Drug: Oral Fluoroquinolones (FQ); Drug: Other Antibiotics; Other: Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure | |
| Cohort 3: Participants with Aortic Aneurysm & Dissection (AAD) | Participants will be defined as having AAD if they received a primary diagnosis for aortic aneurysm, aortic rupture or dissection and have also received an aortic repair surgical procedure concurrently to the AAD diagnosis, in an inpatient or emergency department (ED) setting. Index will be defined as the earlier date of diagnosis or procedure. Participants with AAD, and exposures to FQ or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event will be included. It will use data from 3 databases, which are Truven CCAE and Medicare (Supplemental) and Optum ClinFormatics (Optum). Receives: Drug: Oral Fluoroquinolones (FQ); Drug: Other Antibiotics; Other: Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Events Resulting From Collagen-Related Disorders Achilles Tendon Rupture (ATR), Retinal Detachment (RD) and Aortic Aneurysm and Dissection (AAD) by Exposure to Fluoroquinolones (FQ)
Participants will be having ATR if they receive a diagnosis for ATR and 1 of the following: tenotomy/primary ruptured AT repair (with/without graft) within 7 days of diagnosis. Participants will be having RD if they receive a diagnosis of RD and a procedure for RD, e.g.: sclera buckle, vitrectomy, retinopexy, retinal cryotherapy, silicone oil fill, air gas fluid exchange or pneumatic retinopexy, within 14 days of index (earlier date of diagnosis/procedure). Participants will be having AAD if they receive a diagnosis for aortic aneurysm, aortic rupture/dissection and an aortic repair surgical procedure concurrently to it, in an inpatient/ED setting. The FQ include all oral forms of FQ (ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin). Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to FQ will be assessed using number of events. Temporal associations between RD, ATR or AAD and exposure to FQ will be estimated.
Measured: Approximately up to 6 years
Number of Events Resulting From Collagen-Related Disorders ATR, RD and AAD by Exposure to Other Antibiotics
Other antibiotics includes amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole. Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to other antibiotics will be assessed using number of events. Temporal associations between RD, ATR or AAD and exposure to other antibiotics will be estimated.
Measured: Approximately up to 6 years
Number of Events Resulting From Collagen-Related Disorders ATR, RD and AAD by Febrile Illness Not Treated With Antibiotics
Febrile illness not treated with antibiotics is defined as: concurrent diagnoses of viral disease with concurrent fever, and no concurrent prescription for any antibiotic during the 60-day period before and after the first date of viral disease diagnosis; or a diagnosis of influenza with no concurrent inpatient admission during the 60-day period pre- or post-influenza diagnosis, and no prescription for any antibiotics during the 60-day period pre- or post-influenza diagnosis. Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to febrile illness not treated with antibiotics will be assessed using number of events. Temporal associations between RD, ATR or AAD and febrile illness not treated with antibiotics (analyzed as an exposure) will be estimated.
Measured: Approximately up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start20 Nov 2017
- Primary completion21 May 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 117,911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479736
- Sponsor's protocol ID
- CR108453
- Other IDs
- RRA-19796
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Londhe AA, Holy CE, Weaver J, Fonseca S, Villasis-Keever A, Fife D. Risk of retinal detachment and exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US. PLoS One. 2022 Oct 6;17(10):e0275796. doi: 10.1371/journal.pone.0275796. eCollection 2022.
PubMed 36201545Londhe AA, Holy CE, Weaver J, Fonseca S, Villasis A, Fife D. Risk of aortic aneurysm and dissection following exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US. PLoS One. 2021 Aug 16;16(8):e0255887. doi: 10.1371/journal.pone.0255887. eCollection 2021.
PubMed 34398907
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Controlled Case Series Study of Fluoroquinolones Exposure and Collagen-related Serious Adverse Events
- ClinicalTrials.gov ID
- NCT03479736
- Acronym / sponsor ID
- CR108453
- Conditions
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117,911 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 27 Mar 2018 (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.
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotics, using a study design that minimizes the impact of confounders not usually captured in health services databases such as heredity or smoking.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Participants with Achilles Tendon Rupture (ATR) | – | Drug: Oral Fluoroquinolones (FQ), Drug: Other Antibiotics, Other: Febrile Illness Not Treated with Antibiotics Will be Analyzed as an ExposureParticipants will be defined as having ATR if they receive a diagnosis for ATR as well as one of the following procedures: tenotomy or primary ruptured Achilles Tendon (AT) repair (with or without graft) within 7 days of diagnosis. Index will be based on the earlier date of diagnosis or procedure. Participants with ATR, and exposures to Fluoroquinolone (FQ) or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event will be included. It will use data from 3 databases, which are Truven CCAE and Medicare (Supplemental) and Optum ClinFormatics (Optum). |
| Cohort 2: Participants with Retinal Detachment (RD) | – | Drug: Oral Fluoroquinolones (FQ), Drug: Other Antibiotics, Other: Febrile Illness Not Treated with Antibiotics Will be Analyzed as an ExposureParticipants will be defined as having a RD if they received a diagnosis of RD and a procedure for RD, e.g.: sclera buckle, vitrectomy, retinopexy, retinal cryotherapy, silicone oil fill, air gas fluid exchange or pneumatic retinopexy, within 14 days of index. Index will be defined as the earlier date of diagnosis or procedure. Participants with RD, and exposures to FQ or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event will be included. It will use data from 3 databases, which are Truven CCAE and Medicare (Supplemental) and Optum ClinFormatics (Optum). |
| Cohort 3: Participants with Aortic Aneurysm & Dissection (AAD) | – | Drug: Oral Fluoroquinolones (FQ), Drug: Other Antibiotics, Other: Febrile Illness Not Treated with Antibiotics Will be Analyzed as an ExposureParticipants will be defined as having AAD if they received a primary diagnosis for aortic aneurysm, aortic rupture or dissection and have also received an aortic repair surgical procedure concurrently to the AAD diagnosis, in an inpatient or emergency department (ED) setting. Index will be defined as the earlier date of diagnosis or procedure. Participants with AAD, and exposures to FQ or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event will be included. It will use data from 3 databases, which are Truven CCAE and Medicare (Supplemental) and Optum ClinFormatics (Optum). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants with Achilles Tendon Rupture (ATR) or Retinal Detachment (RD) or Aortic Aneurysm and Dissection (AAD), and exposures to Fluoroquinolones (FQ) or any of the other antibiotics or febrile illness not treated with antibiotic, within a defined study period and at least 1 year of continuous enrollment prior to the event.
Key inclusion criteria (3 listed)
- Have evidence of at least 1 instance of Achilles Tendon Rupture (ATR) or Retinal Detachment (RD) or Aortic Aneurysm and Dissection (AAD)
- Have at least 1 exposure to Fluoroquinolones or any of the other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotic
- Have at least 1 year of continuous enrollment with pharmacy benefits prior to the ATR, RD or AAD
Key exclusion criteria (8 listed)
- Participants who experience the index event while within a time-at-risk window for more than one exposure type. (The exposure types in this study include FQ as a class, amoxicillin, azithromycin, trimethoprim, trimethroprim/sulfamethoxazole, and febrile illness not treated with antibiotics. Events while within a time-at-risk window of two or more exposure types cannot be associated with any one exposure. Participants are therefore excluded from the study)
- Have inherited disorders of connective tissue, specifically: Ehlers-Danlos syndrome, epidermolysis bullosa, Marfan syndrome, osteogenesis imperfecta
- Have an ATR or AAD event prior to index, during the 1-year pre-index period
- Have cataract surgery prior to index
- Have iridotomy or iridectomy prior to index
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 |
|---|---|---|
| Oral Fluoroquinolones (FQ)Participants will not receive any intervention as a part of this study. The FQ include all oral forms of FQ (24-hours extended release tablets, extended release tablets, oral solution, oral suspension, oral tablet, pack). The drugs included are ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin. | Drug | Cohort 1: Participants with Achilles Tendon Rupture (ATR), Cohort 2: Participants with Retinal Detachment (RD), Cohort 3: Participants with Aortic Aneurysm & Dissection (AAD) |
| Other AntibioticsParticipants will not receive any intervention as a part of this study. Other antibiotics include amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole. | Drug | Cohort 1: Participants with Achilles Tendon Rupture (ATR), Cohort 2: Participants with Retinal Detachment (RD), Cohort 3: Participants with Aortic Aneurysm & Dissection (AAD) |
| Febrile Illness Not Treated with Antibiotics Will be Analyzed as an ExposureFebrile illness not treated with antibiotics is defined as: concurrent diagnoses of viral disease with concurrent fever, and no concurrent prescription for any antibiotic during the 60-day period before and after the first date of viral disease diagnosis; or a diagnosis of influenza with no concurrent inpatient admission during the 60-day period pre- or post-influenza diagnosis, and no prescription for any antibiotics during the 60-day period pre- or post-influenza diagnosis. | Other | Cohort 1: Participants with Achilles Tendon Rupture (ATR), Cohort 2: Participants with Retinal Detachment (RD), Cohort 3: Participants with Aortic Aneurysm & Dissection (AAD) |
Primary outcome
Number of Events Resulting From Collagen-Related Disorders Achilles Tendon Rupture (ATR), Retinal Detachment (RD) and Aortic Aneurysm and Dissection (AAD) by Exposure to Fluoroquinolones (FQ)
Time frame: Approximately up to 6 years
Participants will be having ATR if they receive a diagnosis for ATR and 1 of the following: tenotomy/primary ruptured AT repair (with/without graft) within 7 days of diagnosis. Participants will be having RD if they receive a diagnosis of RD and a procedure for RD, e.g.: sclera buckle, vitrectomy, retinopexy, retinal cryotherapy, silicone oil fill, air gas fluid exchange or pneumatic retinopexy, within 14 days of index (earlier date of diagnosis/procedure). Participants will be having AAD if they receive a diagnosis for aortic aneurysm, aortic rupture/dissection and an aortic repair surgical procedure concurrently to it, in an inpatient/ED setting. The FQ include all oral forms of FQ (ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin). Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to FQ will be assessed using number of events. Temporal associations between RD, ATR or AAD and exposure to FQ will be estimated.
Number of Events Resulting From Collagen-Related Disorders ATR, RD and AAD by Exposure to Other Antibiotics
Time frame: Approximately up to 6 years
Other antibiotics includes amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole. Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to other antibiotics will be assessed using number of events. Temporal associations between RD, ATR or AAD and exposure to other antibiotics will be estimated.
Number of Events Resulting From Collagen-Related Disorders ATR, RD and AAD by Febrile Illness Not Treated With Antibiotics
Time frame: Approximately up to 6 years
Febrile illness not treated with antibiotics is defined as: concurrent diagnoses of viral disease with concurrent fever, and no concurrent prescription for any antibiotic during the 60-day period before and after the first date of viral disease diagnosis; or a diagnosis of influenza with no concurrent inpatient admission during the 60-day period pre- or post-influenza diagnosis, and no prescription for any antibiotics during the 60-day period pre- or post-influenza diagnosis. Relative risk of RD, ATR, and AAD between periods of exposure and non-exposure to febrile illness not treated with antibiotics will be assessed using number of events. Temporal associations between RD, ATR or AAD and febrile illness not treated with antibiotics (analyzed as an exposure) will be estimated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 36201545Londhe AA, Holy CE, Weaver J, Fonseca S, Villasis-Keever A, Fife D. Risk of retinal detachment and exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US. PLoS One. 2022 Oct 6;17(10):e0275796. doi: 10.1371/journal.pone.0275796. eCollection 2022.
- Derived from this study: PubMed 34398907Londhe AA, Holy CE, Weaver J, Fonseca S, Villasis A, Fife D. Risk of aortic aneurysm and dissection following exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US. PLoS One. 2021 Aug 16;16(8):e0255887. doi: 10.1371/journal.pone.0255887. eCollection 2021.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Retinal Detachment and Achilles Tendon, run by Janssen Research & Development, LLC at 1 site in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 25 Jun 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Events Resulting From Collagen-Related Disorders Achilles Tendon Rupture (ATR), Retinal Detachment (RD) and Aortic Aneurysm and Dissection (AAD) by Exposure to Fluoroquinolones (FQ) (time frame: Approximately up to 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479736, which also lists 2 linked publications.
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 25 Jun 2025.