Bacterial KeratitisNCT05655689
The Antibiogram and Outcomes of Antimicrobial Regimens in Microbial Keratitis: A Prospective Cohort Study
An observational study of Bacterial Keratitis and Fungal Keratitis, run by Alexandria University at 1 site in Egypt.
Trial summary
This study is an observational prospective cohort study which aims to generate an antibiogram and to assess the clinical responses and outcomes of microbial keratitis patients, treated with empiric topical antimicrobial therapies, with the main objective being to recommend the most effective empiric therapy. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- Bacterial Keratitis, Fungal Keratitis, Mixed Bacterial and Fungal Keratitis
- What is being tested?
- Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution, Ceftazidime 5% + vancomycin 5% and Gentamicin 1.4% + vancomycin 5%
- How many people
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Dec 2021to 1 Jan 2023
- 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 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Bacterial keratitis, fungal keratitis, and mixed bacterial and fungal keratitis patients attending the Cornea Outpatient Clinic at Alexandria Main University Hospital.
Who may be able to join
- Patients diagnosed with bacterial keratitis either clinically or by culture.
- Patients diagnosed with fungal keratitis either clinically or by culture.
- Patients diagnosed with mixed bacterial and fungal keratitis either clinically or by culture.
Who cannot join
- Patients diagnosed with corneal abrasions and non-infectious corneal ulcers.
- Patients diagnosed with acanthamoeba keratitis as a single causative agent.
- Patients diagnosed with viral keratitis as a single causative agent.
- Patients who are noncompliant to treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cornea Outpatient Clinic at Alexandria Main University Hospital
Alexandria
About this study
Official title: Evaluation of Antibiogram Results and Clinical Response to Prescribed Antimicrobials in Microbial Keratitis Patients
This study is an observational prospective cohort study which aims to generate an antibiogram and to assess the clinical responses and outcomes of microbial keratitis patients, treated with empiric topical antimicrobial therapies, with the main objective being to recommend the most effective empiric therapy. Microbial keratitis patients are attending the Cornea Outpatient Clinic at Alexandria Main University Hospital, Alexandria, Egypt.
Read the detailed description
The main objective of this observational study is to recommend the most effective empiric topical antimicrobial therapy in microbial keratitis, according to the current local antimicrobial resistance data and the clinical outcomes of patients with bacterial, fungal, and mixed bacterial and fungal keratitis being treated with different empiric topical antibiotics and antifungal therapies.
In the study, test results of routinely performed culture and sensitivity on corneal scraping samples and on contact lenses in indicated severe, centrally located, and large ulcers are collected and analyzed. The sensitivity data is utilized to generate an antibiogram to describe the local prevalence of bacteria and fungi causing microbial keratitis and to investigate the prevalence of antimicrobial resistance.
Results of the culture and sensitivity are often delayed, hence empiric broad- spectrum antimicrobial therapy is ideally started after corneal scraping, until laboratory test results are obtained. Broad-spectrum empiric therapy will be modified into a more selective culture- guided therapy if the causative agent and its antimicrobial sensitivity are identified.
Empiric therapy continues in cases where the culture results are negative together with clinical improvement. Also, when patients have already been on empiric treatment before presenting to the clinic, corneal scraping and culture are not performed.
In the study, microbial keratitis patients diagnosed as either bacterial, fungal, or mixed bacterial and fungal keratitis, taking the empiric topical antimicrobials, are observed. The study investigator 's role is to observe and study the clinical responses and treatment outcomes of microbial keratitis patients who are on different empiric antimicrobial therapies as part of the routine medical care. There is no assignment of any intervention to the study participants. The investigator does not intervene, and does not prescribe, recommend, or assign any intervention to the study participants.
The clinical response of microbial keratitis patients, who are on different empiric antibiotics and antifungal eye drops, is studied by determining the primary and secondary outcomes. Measured outcomes include corneal ulcer healing, time to epithelialization, improvement in visual acuity, rates of surgical interventions and complications.
- Conditions
- Bacterial Keratitis, Fungal Keratitis, Mixed Bacterial and Fungal Keratitis, Microbial Keratitis
- Being tested
- Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution, Ceftazidime 5% + vancomycin 5%, Gentamicin 1.4% + vancomycin 5%, Natamycin 5% Oph Susp, Voriconazole 1%
- Keywords
- Microbial keratitis, Infectious corneal ulcer, Bacterial keratitis, Fungal keratitis, Mycotic keratitis, Antibiogram, Antimicrobial resistance, Culture, Sensitivity, Fortified antibiotics eye drops, Moxifloxacin, Natamycin, Voriconazole, Prevalence, Antifungal eye drops, Bacteria, Fungi, Vancomycin, Ceftazidime, Gentamicin
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin Ophthalmic 0.5% Ophthalmic SolutionDrug
Also called Vigamox®
In the observational study, patients treated with topical antibiotic moxifloxacin 0.5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
Ceftazidime 5% + vancomycin 5%Drug
Also called (CAZ-VAN)
In the observational study, patients treated with topical fortified antibiotics ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
Gentamicin 1.4% + vancomycin 5%Drug
Also called (GEN-VAN)
In the observational study, patients treated with the topical fortified antibiotics gentamicin 1.4% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
Natamycin 5% Oph SuspDrug
In the observational study, patients treated with the topical natamycin 5% antifungal eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
Voriconazole 1%Drug
Also called Vfend®
In the observational study, patients treated with voriconazole 1% antifungal eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
Natamycin 5% + voriconazole 1%Drug
Also called (NT-VRC)
In the observational study, patients treated with the topical natamycin 5% and voriconazole 1% antifungals eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
Natamycin 5%+ ceftazidime 5% + vancomycin 5%Drug
Also called (NT-CAZ-VAN)
In the observational study, patients treated with the topical natamycin 5% and antifungal and the fortified antibiotic ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
Voriconazole 1% + ceftazidime 5% + vancomycin 5%Drug
Also called (VRC-CAZ-VAN)
In the observational study, patients treated with the topical voriconazole 1% antifungal and the fortified antibiotics ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.
| Study group | Role | What they receive |
|---|---|---|
| Bacterial keratitis | Microbial keratitis patients diagnosed with bacterial keratitis and treated with the empiric topical antibiotics eye drops at the usual doses for the management of bacterial keratitis, as part of routine medical care. Receives: Drug: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution; Drug: Ceftazidime 5% + vancomycin 5%; Drug: Gentamicin 1.4% + vancomycin 5% | |
| Fungal keratitis | Microbial keratitis patients diagnosed with fungal keratitis and treated with the empiric topical antifungals eye drops at the usual doses for the management of fungal keratitis, as part of routine medical care. Receives: Drug: Natamycin 5% Oph Susp; Drug: Voriconazole 1%; Drug: Natamycin 5% + voriconazole 1% | |
| Mixed bacterial and fungal keratitis | Microbial keratitis patients diagnosed with mixed bacterial and fungal keratitis and treated with the empiric topical antibiotics and antifungals eye drops at the usual doses for the management of mixed bacterial and fungal keratitis, as part of routine medical care. Receives: Drug: Natamycin 5%+ ceftazidime 5% + vancomycin 5%; Drug: Voriconazole 1% + ceftazidime 5% + vancomycin 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal ulcer healing
An ulcer is recognized as healed when there is a lack of epithelial defect, and no infiltrates. This is detected by the routine examination under the cobalt-blue light of the slit lamp biomicroscope. The absence of fluorescein staining when fluorescein is applied to the ulcer indicates an intact epithelium.
Measured: 4 months from participation
The time to epithelialization
The time required to re-epithelialization of the corneal ulcer is measured in days.
Measured: 4 months from participation
The antibiogram generation
The corneal scraping culture and sensitivity test results are collected to produce the local antibiogram. Antimicrobial susceptibility is determined using the standard agar disc-diffusion method (Kirby-Bauer) by measuring the zone of inhibition. For each isolate, percentage susceptibility to the antimicrobial is calculated by dividing the number of susceptible isolates by the total number of tested isolates.
Measured: 4 months from participation
Secondary outcomes (5)
The best spectacle-corrected visual acuity
The best spectacle-corrected visual acuity (BCVA) is routinely measured using the Snellen chart. The baseline (BCVA) and the post-treatment (BCVA) are recorded as decimal values of Snellen fractions. For patients with very low vision, the semiquantitative scale of counting fingers (CF), hand motion (HM), perception of light (PL) and no perception of light (NPL) is quantified by their conversion into the equivalent decimal values using the Freiburg Visual Acuity Test (FrACT). The improvement in (BCVA) is measured by finding the difference between the post-treatment BCVA and the baseline BCVA.
Measured: 4 months from participation
Surgical interventions
The percentage of surgical interventions is calculated. An example of surgical intervention is therapeutic penetrating keratoplasty (TKP)
Measured: 4 months from participation
Corneal perforations
The percentage of corneal perforations is calculated. Corneal perforations are routinely tested by the Seidel test on slit lamp biomicroscope examination with cobalt blue light.
Measured: 4 months from participation
Corneal melting
The percentage of corneal melting is calculated. Corneal melting is clinically diagnosed by the slit lamp biomicroscope examination.
Measured: 4 months from participation
Corneal opacities
The percentage of corneal opacities is calculated. The presence of corneal opacity is detected by the slit lamp biomicroscope examination.
Measured: 4 months from participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start31 Dec 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial KeratitisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly M Mohamed, PhD, Principal investigator, Associate Professor of Microbiology and Immunology, Alexandria UniversityTamer H Massoud, PhD, Principal investigator, Associate Professor of Ophthalmology, Alexandria UniversityNoha A Hamdy, PhD, Principal investigator, Assistant Professor of Clinical Pharmacy, Alexandria UniversityAmira A Nayel, PharmD, Principal investigator, Master's student at the Department of Clinical Pharmacy and Pharmacy Practice, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655689
- Sponsor's protocol ID
- ID 0106991
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nayel AA, Hamdy NA, Massoud TH, Mohamed NM. A comparison of antimicrobial regimen outcomes and antibiogram development in microbial keratitis: a prospective cohort study in Alexandria, Egypt. Graefes Arch Clin Exp Ophthalmol. 2024 Jun;262(6):1865-1882. doi: 10.1007/s00417-023-06362-0. Epub 2024 Jan 19.
PubMed 38240778
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibiogram Results and Clinical Response to Prescribed Antimicrobials in Microbial Keratitis Patients
- ClinicalTrials.gov ID
- NCT05655689
- Acronym / sponsor ID
- ID 0106991
- Conditions
- Bacterial Keratitis, Fungal Keratitis, Mixed Bacterial and Fungal Keratitis, Microbial Keratitis
- Keywords
- Microbial keratitis, Infectious corneal ulcer, Bacterial keratitis, Fungal keratitis, Mycotic keratitis, Antibiogram, Antimicrobial resistance, Culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 19 Dec 2022 (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.
This study is an observational prospective cohort study which aims to generate an antibiogram and to assess the clinical responses and outcomes of microbial keratitis patients, treated with empiric topical antimicrobial therapies, with the main objective being to recommend the most effective empiric therapy. Microbial keratitis patients are attending the Cornea Outpatient Clinic at Alexandria Main University Hospital, Alexandria, Egypt.
Detailed description
The main objective of this observational study is to recommend the most effective empiric topical antimicrobial therapy in microbial keratitis, according to the current local antimicrobial resistance data and the clinical outcomes of patients with bacterial, fungal, and mixed bacterial and fungal keratitis being treated with different empiric topical antibiotics and antifungal therapies.
In the study, test results of routinely performed culture and sensitivity on corneal scraping samples and on contact lenses in indicated severe, centrally located, and large ulcers are collected and analyzed. The sensitivity data is utilized to generate an antibiogram to describe the local prevalence of bacteria and fungi causing microbial keratitis and to investigate the prevalence of antimicrobial resistance.
Results of the culture and sensitivity are often delayed, hence empiric broad- spectrum antimicrobial therapy is ideally started after corneal scraping, until laboratory test results are obtained. Broad-spectrum empiric therapy will be modified into a more selective culture- guided therapy if the causative agent and its antimicrobial sensitivity are identified.
Empiric therapy continues in cases where the culture results are negative together with clinical improvement. Also, when patients have already been on empiric treatment before presenting to the clinic, corneal scraping and culture are not performed.
In the study, microbial keratitis patients diagnosed as either bacterial, fungal, or mixed bacterial and fungal keratitis, taking the empiric topical antimicrobials, are observed. The study investigator 's role is to observe and study the clinical responses and treatment outcomes of microbial keratitis patients who are on different empiric antimicrobial therapies as part of the routine medical care. There is no assignment of any intervention to the study participants. The investigator does not intervene, and does not prescribe, recommend, or assign any intervention to the study participants.
The clinical response of microbial keratitis patients, who are on different empiric antibiotics and antifungal eye drops, is studied by determining the primary and secondary outcomes. Measured outcomes include corneal ulcer healing, time to epithelialization, improvement in visual acuity, rates of surgical interventions and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bacterial keratitis | – | Drug: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution, Drug: Ceftazidime 5% + vancomycin 5%, Drug: Gentamicin 1.4% + vancomycin 5%Microbial keratitis patients diagnosed with bacterial keratitis and treated with the empiric topical antibiotics eye drops at the usual doses for the management of bacterial keratitis, as part of routine medical care. |
| Fungal keratitis | – | Drug: Natamycin 5% Oph Susp, Drug: Voriconazole 1%, Drug: Natamycin 5% + voriconazole 1%Microbial keratitis patients diagnosed with fungal keratitis and treated with the empiric topical antifungals eye drops at the usual doses for the management of fungal keratitis, as part of routine medical care. |
| Mixed bacterial and fungal keratitis | – | Drug: Natamycin 5%+ ceftazidime 5% + vancomycin 5%, Drug: Voriconazole 1% + ceftazidime 5% + vancomycin 5%Microbial keratitis patients diagnosed with mixed bacterial and fungal keratitis and treated with the empiric topical antibiotics and antifungals eye drops at the usual doses for the management of mixed bacterial and fungal keratitis, as part of routine medical care. |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Bacterial keratitis, fungal keratitis, and mixed bacterial and fungal keratitis patients attending the Cornea Outpatient Clinic at Alexandria Main University Hospital.
Key inclusion criteria (3 listed)
- Patients diagnosed with bacterial keratitis either clinically or by culture.
- Patients diagnosed with fungal keratitis either clinically or by culture.
- Patients diagnosed with mixed bacterial and fungal keratitis either clinically or by culture.
Key exclusion criteria (4 listed)
- Patients diagnosed with corneal abrasions and non-infectious corneal ulcers.
- Patients diagnosed with acanthamoeba keratitis as a single causative agent.
- Patients diagnosed with viral keratitis as a single causative agent.
- Patients who are noncompliant to treatment.
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 |
|---|---|---|
| Moxifloxacin Ophthalmic 0.5% Ophthalmic SolutionAlso: Vigamox®In the observational study, patients treated with topical antibiotic moxifloxacin 0.5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Bacterial keratitis |
| Ceftazidime 5% + vancomycin 5%Also: (CAZ-VAN)In the observational study, patients treated with topical fortified antibiotics ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Bacterial keratitis |
| Gentamicin 1.4% + vancomycin 5%Also: (GEN-VAN)In the observational study, patients treated with the topical fortified antibiotics gentamicin 1.4% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Bacterial keratitis |
| Natamycin 5% Oph SuspIn the observational study, patients treated with the topical natamycin 5% antifungal eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Fungal keratitis |
| Voriconazole 1%Also: Vfend®In the observational study, patients treated with voriconazole 1% antifungal eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Fungal keratitis |
| Natamycin 5% + voriconazole 1%Also: (NT-VRC)In the observational study, patients treated with the topical natamycin 5% and voriconazole 1% antifungals eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Fungal keratitis |
| Natamycin 5%+ ceftazidime 5% + vancomycin 5%Also: (NT-CAZ-VAN)In the observational study, patients treated with the topical natamycin 5% and antifungal and the fortified antibiotic ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Mixed bacterial and fungal keratitis |
| Voriconazole 1% + ceftazidime 5% + vancomycin 5%Also: (VRC-CAZ-VAN)In the observational study, patients treated with the topical voriconazole 1% antifungal and the fortified antibiotics ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants. | Drug | Mixed bacterial and fungal keratitis |
Primary outcome
Corneal ulcer healing
Time frame: 4 months from participation
An ulcer is recognized as healed when there is a lack of epithelial defect, and no infiltrates. This is detected by the routine examination under the cobalt-blue light of the slit lamp biomicroscope. The absence of fluorescein staining when fluorescein is applied to the ulcer indicates an intact epithelium.
The time to epithelialization
Time frame: 4 months from participation
The time required to re-epithelialization of the corneal ulcer is measured in days.
The antibiogram generation
Time frame: 4 months from participation
The corneal scraping culture and sensitivity test results are collected to produce the local antibiogram. Antimicrobial susceptibility is determined using the standard agar disc-diffusion method (Kirby-Bauer) by measuring the zone of inhibition. For each isolate, percentage susceptibility to the antimicrobial is calculated by dividing the number of susceptible isolates by the total number of tested isolates.
5 secondary outcomes
The best spectacle-corrected visual acuity
Time frame: 4 months from participation
Surgical interventions
Time frame: 4 months from participation
Corneal perforations
Time frame: 4 months from participation
Corneal melting
Time frame: 4 months from participation
Corneal opacities
Time frame: 4 months from participation
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 Jan 2024.
- Background: PubMed 38240778Nayel AA, Hamdy NA, Massoud TH, Mohamed NM. A comparison of antimicrobial regimen outcomes and antibiogram development in microbial keratitis: a prospective cohort study in Alexandria, Egypt. Graefes Arch Clin Exp Ophthalmol. 2024 Jun;262(6):1865-1882. doi: 10.1007/s00417-023-06362-0. Epub 2024 Jan 19.
- Individual participant dataSharing planned: Undecided
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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.
Nelly M Mohamed, PhD principal investigator
Associate Professor of Microbiology and Immunology, Alexandria University
Tamer H Massoud, PhD principal investigator
Associate Professor of Ophthalmology, Alexandria University
Noha A Hamdy, PhD principal investigator
Assistant Professor of Clinical Pharmacy, Alexandria University
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 Bacterial Keratitis and Fungal Keratitis, run by Alexandria University at 1 site in Egypt.
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 4 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 Jan 2024. 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 Egypt. 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?
Corneal ulcer healing (time frame: 4 months from participation). 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 NCT05655689, which also lists 1 linked publication.
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 Jan 2024.