Clostridioides Difficile InfectionPhase 3PREVANNCT05320068
Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
A Phase 3 study testing Oral Vancomycin in people with Clostridioides Difficile Infection, run by Julia Orígüen at 1 site in Spain.
Trial summary
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. The main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of Clostridioides difficile… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- Oral Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 2 Aug 2022to 1 Mar 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal or superior to 18 years
- Previous history of Clostridioides difficile infection in the 90 days before the study enrolment
- Need for hospitalization and need of antibiotic therapy
- Signature of informed consent
Who cannot join
- Woman of childbearing age, pregnant woman, or breastfeeding woman
- Hypersensitivity to vancomycin
- Inability to comply with study protocol
- Critically ill condition or life expectancy less than 30 days
- Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea
- Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment for eligibility or in the previous 3 days
Show all 11Show fewer
- Therapy with oral vancomycin or any other agent with activity against C. difficile for >48 hours in the previous 3 days;.
- Prophylaxis with oral vancomycin or any other agent with activity against C. difficile within the 70 days before the assessment for eligibility
- Systemic antibiotic therapy for 72 hours or more before the recruitment
- Ongoing enrolment in another RCT evaluating the effectiveness of other drugs
- Estimated use of systemic antibiotic therapy for more than 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III,randomized,double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Vs Placebo in the Prevention of Recurrence of C.difficile Infection in Patients Under Treatment with Systemic Antibiotic Therapy
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. The main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered previous CDI and who need further hospitalization and treatment with systemic antibiotic therapy in the 90 days after the first CDI.
Read the detailed description
As secondary objectives the investigators intend to:
- Evaluate the effectiveness of the treatment with oral vancomycin as part of the prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by the number of previous recurrences.
- Compare the severity of recurrences in both study groups.
- Compare the effectiveness of the treatment with oral vancomycin depending on the type of systemic antibiotic therapy prescribed.
- Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of secondary effects and difficulty in therapeutic compliance.
- Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity of ICD recurrences.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- Oral Vancomycin, Placebo
- Keywords
- Vancomycin oral capsules
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral VancomycinDrug
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
PlaceboDrug
A blinded capsule that contains no vancomycin every 6 hours during 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days. Receives: Drug: Oral Vancomycin |
| Placebo group | Placebo comparator | A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
Measured: 60 days after the beginning of the intervention
Secondary outcomes (4)
Effectiveness of treatment with oral vancomycin according to the number of previous recurrences
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by index CDI episode (first episode or recurrence)
Measured: 60 days after the beginning of the intervention
Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence
The absolute difference in the rate of severe C. difficile infection recurrences with vancomycin vs placebo
Measured: 60 days after the beginning of the intervention
Effectiveness of treatment with oral vancomycin depending on antibiotic therapy
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by the type of systemic antibiotic therapy prescribed.
Measured: 60 days after the beginning of the intervention
Tolerance and safety of treatment with oral vancomycin
Rate of major adverse events and drug-related adverse events.
Measured: 60 days after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start2 Aug 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Proportion 2:1 in favour to the intervention arm
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julia Orígüen
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Julia Orígüen, Hospital Universitario 12 de Octubre
- Investigators
- RAFAEL SAN-JUAN, Study chair, HOSPITAL 12 DE OCTUBRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320068
- Sponsor's protocol ID
- PREVAN-ICD
- Acronym
- PREVAN
- Status last verified
- Dec 2024
- First submitted
- 22 Mar 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared
Publications
Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, Lynfield R, Maloney M, McAllister-Hollod L, Nadle J, Ray SM, Thompson DL, Wilson LE, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Multistate point-prevalence survey of health care-associated infections. N Engl J Med. 2014 Mar 27;370(13):1198-208. doi: 10.1056/NEJMoa1306801.
PubMed 24670166Rauseo AM, Olsen MA, Reske KA, Dubberke ER. Strategies to prevent adverse outcomes following Clostridioides difficile infection in the elderly. Expert Rev Anti Infect Ther. 2020 Mar;18(3):203-217. doi: 10.1080/14787210.2020.1717950. Epub 2020 Jan 27.
PubMed 31976779Asensio A, Monge D. [Epidemiology of Clostridium difficile infection in Spain]. Enferm Infecc Microbiol Clin. 2012 Jun;30(6):333-7. doi: 10.1016/j.eimc.2011.09.010. Epub 2011 Dec 2. Spanish.
PubMed 22136747Asensio A, Vaque-Rafart J, Calbo-Torrecillas F, Gestal-Otero JJ, Lopez-Fernandez F, Trilla-Garcia A, Canton R; EPINE Working Group. Increasing rates in Clostridium difficile infection (CDI) among hospitalised patients, Spain 1999-2007. Euro Surveill. 2008 Jul 31;13(31):18943.
PubMed 18761902McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996-2003. Emerg Infect Dis. 2006 Mar;12(3):409-15. doi: 10.3201/eid1205.051064.
PubMed 16704777Eyre DW, Walker AS, Wyllie D, Dingle KE, Griffiths D, Finney J, O'Connor L, Vaughan A, Crook DW, Wilcox MH, Peto TE; Infections in Oxfordshire Research Database. Predictors of first recurrence of Clostridium difficile infection: implications for initial management. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S77-87. doi: 10.1093/cid/cis356.
PubMed 22752869Rodriguez-Pardo D, Almirante B, Bartolome RM, Pomar V, Mirelis B, Navarro F, Soriano A, Sorli L, Martinez-Montauti J, Molins MT, Lung M, Vila J, Pahissa A; Barcelona Clostridium difficile Study Group. Epidemiology of Clostridium difficile infection and risk factors for unfavorable clinical outcomes: results of a hospital-based study in Barcelona, Spain. J Clin Microbiol. 2013 May;51(5):1465-73. doi: 10.1128/JCM.03352-12. Epub 2013 Feb 27.
PubMed 23447638Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012 Dec;18 Suppl 6:21-7. doi: 10.1111/1469-0691.12046.
PubMed 23121551Leav BA, Blair B, Leney M, Knauber M, Reilly C, Lowy I, Gerding DN, Kelly CP, Katchar K, Baxter R, Ambrosino D, Molrine D. Serum anti-toxin B antibody correlates with protection from recurrent Clostridium difficile infection (CDI). Vaccine. 2010 Jan 22;28(4):965-9. doi: 10.1016/j.vaccine.2009.10.144. Epub 2009 Nov 24.
PubMed 19941990Pepin J, Alary ME, Valiquette L, Raiche E, Ruel J, Fulop K, Godin D, Bourassa C. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005 Jun 1;40(11):1591-7. doi: 10.1086/430315. Epub 2005 Apr 25.
PubMed 15889355Hu MY, Katchar K, Kyne L, Maroo S, Tummala S, Dreisbach V, Xu H, Leffler DA, Kelly CP. Prospective derivation and validation of a clinical prediction rule for recurrent Clostridium difficile infection. Gastroenterology. 2009 Apr;136(4):1206-14. doi: 10.1053/j.gastro.2008.12.038. Epub 2008 Dec 13.
PubMed 19162027Deshpande A, Pasupuleti V, Thota P, Pant C, Rolston DD, Hernandez AV, Donskey CJ, Fraser TG. Risk factors for recurrent Clostridium difficile infection: a systematic review and meta-analysis. Infect Control Hosp Epidemiol. 2015 Apr;36(4):452-60. doi: 10.1017/ice.2014.88. Epub 2015 Jan 28.
PubMed 25626326Cadena J, Thompson GR 3rd, Patterson JE, Nakashima B, Owens A, Echevarria K, Mortensen EM. Clinical predictors and risk factors for relapsing Clostridium difficile infection. Am J Med Sci. 2010 Apr;339(4):350-5. doi: 10.1097/MAJ.0b013e3181d3cdaa.
PubMed 20224312Ghantoji SS, Sail K, Lairson DR, DuPont HL, Garey KW. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect. 2010 Apr;74(4):309-18. doi: 10.1016/j.jhin.2009.10.016. Epub 2010 Feb 12.
PubMed 20153547Larrainzar-Coghen T, Rodriguez-Pardo D, Puig-Asensio M, Rodriguez V, Ferrer C, Bartolome R, Pigrau C, Fernandez-Hidalgo N, Pumarola T, Almirante B. First recurrence of Clostridium difficile infection: clinical relevance, risk factors, and prognosis. Eur J Clin Microbiol Infect Dis. 2016 Mar;35(3):371-8. doi: 10.1007/s10096-015-2549-9. Epub 2016 Jan 11.
PubMed 26753991
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III,randomized,double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Vs Placebo in the Prevention of Recurrence of C.difficile Infection in Patients Under Treatment with Systemic Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT05320068
- Acronym / sponsor ID
- PREVAN / PREVAN-ICD
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Vancomycin oral capsules
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Julia OrígüenUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 11 Apr 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.
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. The main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered previous CDI and who need further hospitalization and treatment with systemic antibiotic therapy in the 90 days after the first CDI.
Detailed description
As secondary objectives the investigators intend to:
- Evaluate the effectiveness of the treatment with oral vancomycin as part of the prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by the number of previous recurrences.
- Compare the severity of recurrences in both study groups.
- Compare the effectiveness of the treatment with oral vancomycin depending on the type of systemic antibiotic therapy prescribed.
- Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of secondary effects and difficulty in therapeutic compliance.
- Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity of ICD recurrences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Proportion 2:1 in favour to the intervention arm
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Oral VancomycinA group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days. |
| Placebo group | Placebo comparator | Drug: PlaceboA group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal or superior to 18 years
- Previous history of Clostridioides difficile infection in the 90 days before the study enrolment
- Need for hospitalization and need of antibiotic therapy
- Signature of informed consent
Key exclusion criteria (11 listed)
- Woman of childbearing age, pregnant woman, or breastfeeding woman
- Hypersensitivity to vancomycin
- Inability to comply with study protocol
- Critically ill condition or life expectancy less than 30 days
- Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea
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 VancomycinA blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days. | Drug | Intervention group |
| PlaceboA blinded capsule that contains no vancomycin every 6 hours during 10 days. | Drug | Placebo group |
Primary outcome
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
Time frame: 60 days after the beginning of the intervention
Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
4 secondary outcomes
Effectiveness of treatment with oral vancomycin according to the number of previous recurrences
Time frame: 60 days after the beginning of the intervention
Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence
Time frame: 60 days after the beginning of the intervention
Effectiveness of treatment with oral vancomycin depending on antibiotic therapy
Time frame: 60 days after the beginning of the intervention
Tolerance and safety of treatment with oral vancomycin
Time frame: 60 days after the beginning of the intervention
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 12 Dec 2024.
- Background: PubMed 24670166Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, Lynfield R, Maloney M, McAllister-Hollod L, Nadle J, Ray SM, Thompson DL, Wilson LE, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Multistate point-prevalence survey of health care-associated infections. N Engl J Med. 2014 Mar 27;370(13):1198-208. doi: 10.1056/NEJMoa1306801.
- Background: PubMed 31976779Rauseo AM, Olsen MA, Reske KA, Dubberke ER. Strategies to prevent adverse outcomes following Clostridioides difficile infection in the elderly. Expert Rev Anti Infect Ther. 2020 Mar;18(3):203-217. doi: 10.1080/14787210.2020.1717950. Epub 2020 Jan 27.
- Background: PubMed 22136747Asensio A, Monge D. [Epidemiology of Clostridium difficile infection in Spain]. Enferm Infecc Microbiol Clin. 2012 Jun;30(6):333-7. doi: 10.1016/j.eimc.2011.09.010. Epub 2011 Dec 2. Spanish.
- Background: PubMed 18761902Asensio A, Vaque-Rafart J, Calbo-Torrecillas F, Gestal-Otero JJ, Lopez-Fernandez F, Trilla-Garcia A, Canton R; EPINE Working Group. Increasing rates in Clostridium difficile infection (CDI) among hospitalised patients, Spain 1999-2007. Euro Surveill. 2008 Jul 31;13(31):18943.
- Background: PubMed 16704777McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996-2003. Emerg Infect Dis. 2006 Mar;12(3):409-15. doi: 10.3201/eid1205.051064.
- Background: PubMed 22752869Eyre DW, Walker AS, Wyllie D, Dingle KE, Griffiths D, Finney J, O'Connor L, Vaughan A, Crook DW, Wilcox MH, Peto TE; Infections in Oxfordshire Research Database. Predictors of first recurrence of Clostridium difficile infection: implications for initial management. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S77-87. doi: 10.1093/cid/cis356.
- Background: PubMed 23447638Rodriguez-Pardo D, Almirante B, Bartolome RM, Pomar V, Mirelis B, Navarro F, Soriano A, Sorli L, Martinez-Montauti J, Molins MT, Lung M, Vila J, Pahissa A; Barcelona Clostridium difficile Study Group. Epidemiology of Clostridium difficile infection and risk factors for unfavorable clinical outcomes: results of a hospital-based study in Barcelona, Spain. J Clin Microbiol. 2013 May;51(5):1465-73. doi: 10.1128/JCM.03352-12. Epub 2013 Feb 27.
- Background: PubMed 23121551Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012 Dec;18 Suppl 6:21-7. doi: 10.1111/1469-0691.12046.
- Background: PubMed 19941990Leav BA, Blair B, Leney M, Knauber M, Reilly C, Lowy I, Gerding DN, Kelly CP, Katchar K, Baxter R, Ambrosino D, Molrine D. Serum anti-toxin B antibody correlates with protection from recurrent Clostridium difficile infection (CDI). Vaccine. 2010 Jan 22;28(4):965-9. doi: 10.1016/j.vaccine.2009.10.144. Epub 2009 Nov 24.
- Background: PubMed 15889355Pepin J, Alary ME, Valiquette L, Raiche E, Ruel J, Fulop K, Godin D, Bourassa C. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005 Jun 1;40(11):1591-7. doi: 10.1086/430315. Epub 2005 Apr 25.
- Background: PubMed 19162027Hu MY, Katchar K, Kyne L, Maroo S, Tummala S, Dreisbach V, Xu H, Leffler DA, Kelly CP. Prospective derivation and validation of a clinical prediction rule for recurrent Clostridium difficile infection. Gastroenterology. 2009 Apr;136(4):1206-14. doi: 10.1053/j.gastro.2008.12.038. Epub 2008 Dec 13.
- Background: PubMed 25626326Deshpande A, Pasupuleti V, Thota P, Pant C, Rolston DD, Hernandez AV, Donskey CJ, Fraser TG. Risk factors for recurrent Clostridium difficile infection: a systematic review and meta-analysis. Infect Control Hosp Epidemiol. 2015 Apr;36(4):452-60. doi: 10.1017/ice.2014.88. Epub 2015 Jan 28.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared
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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.
RAFAEL SAN-JUAN study chair
HOSPITAL 12 DE OCTUBRE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Vancomycin in people with Clostridioides Difficile Infection, run by Julia Orígüen at 1 site in Spain.
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 4 inclusion and 11 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 12 Dec 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile (time frame: 60 days after the beginning of the intervention). 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 NCT05320068, which also lists 31 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 12 Dec 2024.