Clostridium Difficile InfectionNCT04259931
PROSPECTIVE STUDY OF PREDISPOSING FACTORS OF REFRACTARY Clostridium Difficile INFECTION. INFLUENCE OF THE GUT MICROBIOMA
An observational study of Clostridium Difficile Infection, run by Hospital Universitario de Cabuenes.
Trial summary
A higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- microbiome analysis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infeopiction at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021 For the purpose of the study we define case as a patient with C. difficile infection demonstrated in stool samples in presence of compatible gastrointestinal diseases. We define a positive microbiological result if the patient had a determination of toxin plus GDH positives or there is colonoscopy or histopathological evidence of pseudomembranous colitis. The discordant cases will be confirmed by PCR, and we consider that infection exits if it is positive Recurrence will be considered if the patient presents a new episode of C. difficile infection if he / she presents again compatible clinical and positive microbiological diagnosis in the 60 days following the previous episode.
Who may be able to join
- Diagnosed of C. difficile infection
- Age older than 18 years old.
Who cannot join
- Failing to meet the inclusion criteria
- If the positive microbiological results were not associated with clinical features of gastrointestinal infection.
- Patients with incomplete data.
Trial locations and contacts
No sites are listed yet.
About this study
A higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found. This increase does not seem to be related to underlying diseases, age, sex or predisposing factors classically described in this type of infection. This high rate of recurrence, together with the absence of response to all conventionally used antibiotic treatments, has important repercussions in the morbidity and mortality of patients, in the ecology of the hospital due to the risk of transmission of a strain of major severity and in the high costs associated with an increase in the hospitalization days of these patients, as well as in an eventual transfer of these to other structures specialized in fecal transplantation.
Two hypotheses are proposed to explain the higher frequency reported:
Read more
Hypothesis 1. There are alterations of the microbiome in patients with severe recurrences that favor the appearance of these.
Hypothesis 2. The circulating strain in the hospital has intrinsic characteristics that make it more virulent, such as the presence of virulence or multiresistance factors.
For this reason we design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infection at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021
Read the detailed description
Clostridium difficile infection (CDI) is currently a priority public health problem. In recent decades, the exponential increase in the incidence and severity of CDI has forced to develop new and better methods of treatment and control of the infection. Currently, it is the most common cause of nosocomial infectious diarrhea, with 20 cases per 100,000 people / year or 15 cases per 1000 hospital discharges.
The identification of risk factors for the CDI has become one of the basic pillars to study in order to improve epidemiological control. Classically known risk factors associated with CDI (hospitalization, advanced age, antibiotic prescription, gastrointestinal surgery) have joined in recent years as a result of recent research (for example, the use of proton pump inhibitors).
One of the main problems offered by the management of the CDI is the role of recurrences. There is no consensus about the definition of recurrence in the international CDI management guidelines, however, it is usually established as the presence of diarrhea in the 30 days after an CDI that had presented positive toxin.
The recurrence of the CDI implies a new level of complexity when dealing with the management of this infection: the recurrence percentages range between 15-50% after an initial episode, establishing in recent studies that it could be reasonable to estimate that 20-25% of the patients will present a recurrence in the first 30 days after finishing the antibiotic treatment for the CDI. In addition, after the first recurrence the risk of presenting a new one increases up to 45%, and the risk of subsequent recurrences doubles after 2 or more recurrences.
The study of recurrence in the CDI is the objective of multiple studies. Its importance is based on both epidemiological and economic reasons, since each episode of recurrence increases hospital costs (in a study carried out by the Spanish Ministry of Health in 2013, it was estimated that each new episode of recurrence entailed an increase in the cost of 1000 euros)
The new lines of recurrence research in CDI try to find associations between severity, microbiome, demographic findings and new risk factors and the possibility of recurrence, in order to try to predict it by developing clinical models predictive of recurrence, which, until now, they only have a very limited role.
Previous data collected by our working group show important differences in the behavior of Clostridium difficile infection between the Central University Hospital of Asturias (HUCA) and the University Hospital of Cabueñes (HUCAB), among which the high number of recurrences and failures to conventional treatments in the latter, being necessary even fecal transplantation as a last therapeutic resource.
In 2017, there were 27 patients with Clostridium difficile infection in the HUCAB, of whom 8 (33.3%) relapsed. In 2018, 4 (22.2%) of 18 patients relapsed, three of them more than three times. Analyzing the characteristics of patients with recurrence within the HUCAB during the years 2017-2018, we found that recurrences are significantly more frequent in patients treated with metronidazole, although this is possibly due to the fact that it is the drug used systematically as the first choice, and diagnosed with hepatopathy without differences between the other treatments, which supports the hypothesis that the differences are due more to the behavior of the strain than to the clinical characteristics of the patients.
A higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found. This increase does not seem to be related to underlying diseases, age, sex or predisposing factors classically described in this type of infection. This high rate of recurrence, together with the absence of response to all conventionally used antibiotic treatments, has important repercussions in the morbidity and mortality of patients, in the ecology of the hospital due to the risk of transmission of a strain of major severity and in the high costs associated with an increase in the hospitalization days of these patients, as well as in an eventual transfer of these to other structures specialized in fecal transplantation.
Two hypotheses are proposed to explain the higher frequency reported:
Hypothesis 1. There are alterations of the microbiome in patients with severe recurrences that favor the appearance of these.
Hypothesis 2. The circulating strain in the hospital has intrinsic characteristics that make it more virulent, such as the presence of virulence or multiresistance factors We design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infection at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021
- Conditions
- Clostridium Difficile Infection
- Being tested
- microbiome analysis
- Keywords
- Clostridium difficile, relapse, microbiome
- Medical subject headings
- Clostridium Infections, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiome analysisDiagnostic test
gut microbiome composition of C. difficile infected patients with relapsing (basal, at the end of first treatment, at the begin of the relapses and at four and twelve weeks after definitive treatment) and non-relapsing ( basal and four and twelve week after treatment) , will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| No relapses | Patients with clostridium difficile infections without relapses Receives: Diagnostic Test: microbiome analysis | |
| Relapsing patiens | Patients with clostridium difficile infections with relapses Receives: Diagnostic Test: microbiome analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of risk factors
identify risk factors linked to the appearance of serious relapses in patients infected with Clostridium difficile, with special emphasis on the relationship between changes in the patient's microbiota and the appearance of these recurrences.
Measured: 12 weeks
Secondary outcomes (2)
Characterization of the circulating strain: profile of resistance, ribotype and presence of virulence factors.
Characterization of the circulating strain: profile of resistance, ribotype and presence of virulence factors.
Measured: 16 weeks
Study of the alterations in the microbiome of Clostridium difficile-infected patients with relapsing and non-relapsing.
Study of the alterations in the microbiome of Clostridium difficile-infected patients with relapsing and non-relapsing.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Clostridium 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Cabuenes
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hospital Universitario Central de Asturias, Instituto de Productos Lacteos de Asturias
- Responsible party
- Principal investigator, Azucena Rodriguez Guardado, Hospital Universitario de Cabuenes
- Investigators
- Azucena Rodriguez Guardado, MdPhd, Principal investigator, Hospital Universitario de Cabuenes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259931
- Sponsor's protocol ID
- CLOSTRI PROJECT
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradley CW, Burdett H, Holden KL, Holden E, Garvey MI. How do we define recurrence in Clostridium difficile infection? J Hosp Infect. 2019 Jun;102(2):171-173. doi: 10.1016/j.jhin.2018.07.026. Epub 2018 Jul 26. No abstract available.
PubMed 30055221Pakpour S, Bhanvadia A, Zhu R, Amarnani A, Gibbons SM, Gurry T, Alm EJ, Martello LA. Identifying predictive features of Clostridium difficile infection recurrence before, during, and after primary antibiotic treatment. Microbiome. 2017 Nov 13;5(1):148. doi: 10.1186/s40168-017-0368-1.
PubMed 29132405Petrosillo N. Tackling the recurrence of Clostridium difficile infection. Med Mal Infect. 2018 Feb;48(1):18-22. doi: 10.1016/j.medmal.2017.10.007. Epub 2018 Jan 12.
PubMed 29336928Falcone M, Tiseo G, Iraci F, Raponi G, Goldoni P, Delle Rose D, Santino I, Carfagna P, Murri R, Fantoni M, Fontana C, Sanguinetti M, Farcomeni A, Antonelli G, Aceti A, Mastroianni C, Andreoni M, Cauda R, Petrosillo N, Venditti M. Risk factors for recurrence in patients with Clostridium difficile infection due to 027 and non-027 ribotypes. Clin Microbiol Infect. 2019 Apr;25(4):474-480. doi: 10.1016/j.cmi.2018.06.020. Epub 2018 Jun 28.
PubMed 29964230Song JH, Kim YS. Recurrent Clostridium difficile Infection: Risk Factors, Treatment, and Prevention. Gut Liver. 2019 Jan 15;13(1):16-24. doi: 10.5009/gnl18071.
PubMed 30400734Ford DC, Schroeder MC, Ince D, Ernst EJ. Cost-effectiveness analysis of initial treatment strategies for mild-to-moderate Clostridium difficile infection in hospitalized patients. Am J Health Syst Pharm. 2018 Aug 1;75(15):1110-1121. doi: 10.2146/ajhp170554. Epub 2018 Jun 14.
PubMed 29903711Tieu JD, Williams RJ 2nd, Skrepnek GH, Gentry CA. Clinical outcomes of fidaxomicin vs oral vancomycin in recurrent Clostridium difficile infection. J Clin Pharm Ther. 2019 Apr;44(2):220-228. doi: 10.1111/jcpt.12771. Epub 2018 Oct 22.
PubMed 30350418Asensio A, Bouza E, Grau S, Rubio-Rodriguez D, Rubio-Terres C. [Cost of Clostridium difficile associated diarrhea in Spain]. Rev Esp Salud Publica. 2013 Jan-Feb;87(1):25-33. doi: 10.4321/S1135-57272013000100004. Spanish.
PubMed 23748655
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE STUDY OF PREDISPOSING FACTORS OF REFRACTARY Clostridium Difficile INFECTION. INFLUENCE OF THE GUT MICROBIOMA
- ClinicalTrials.gov ID
- NCT04259931
- Acronym / sponsor ID
- CLOSTRI PROJECT
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile, relapse, microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitario de CabuenesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hospital Universitario Central de Asturias, Instituto de Productos Lacteos de Asturias
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 7 Feb 2020 (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 higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found. This increase does not seem to be related to underlying diseases, age, sex or predisposing factors classically described in this type of infection. This high rate of recurrence, together with the absence of response to all conventionally used antibiotic treatments, has important repercussions in the morbidity and mortality of patients, in the ecology of the hospital due to the risk of transmission of a strain of major severity and in the high costs associated with an increase in the hospitalization days of these patients, as well as in an eventual transfer of these to other structures specialized in fecal transplantation.
Two hypotheses are proposed to explain the higher frequency reported:
Hypothesis 1. There are alterations of the microbiome in patients with severe recurrences that favor the appearance of these.
Hypothesis 2. The circulating strain in the hospital has intrinsic characteristics that make it more virulent, such as the presence of virulence or multiresistance factors.
For this reason we design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infection at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021
Detailed description
Clostridium difficile infection (CDI) is currently a priority public health problem. In recent decades, the exponential increase in the incidence and severity of CDI has forced to develop new and better methods of treatment and control of the infection. Currently, it is the most common cause of nosocomial infectious diarrhea, with 20 cases per 100,000 people / year or 15 cases per 1000 hospital discharges.
The identification of risk factors for the CDI has become one of the basic pillars to study in order to improve epidemiological control. Classically known risk factors associated with CDI (hospitalization, advanced age, antibiotic prescription, gastrointestinal surgery) have joined in recent years as a result of recent research (for example, the use of proton pump inhibitors).
One of the main problems offered by the management of the CDI is the role of recurrences. There is no consensus about the definition of recurrence in the international CDI management guidelines, however, it is usually established as the presence of diarrhea in the 30 days after an CDI that had presented positive toxin.
The recurrence of the CDI implies a new level of complexity when dealing with the management of this infection: the recurrence percentages range between 15-50% after an initial episode, establishing in recent studies that it could be reasonable to estimate that 20-25% of the patients will present a recurrence in the first 30 days after finishing the antibiotic treatment for the CDI. In addition, after the first recurrence the risk of presenting a new one increases up to 45%, and the risk of subsequent recurrences doubles after 2 or more recurrences.
The study of recurrence in the CDI is the objective of multiple studies. Its importance is based on both epidemiological and economic reasons, since each episode of recurrence increases hospital costs (in a study carried out by the Spanish Ministry of Health in 2013, it was estimated that each new episode of recurrence entailed an increase in the cost of 1000 euros)
The new lines of recurrence research in CDI try to find associations between severity, microbiome, demographic findings and new risk factors and the possibility of recurrence, in order to try to predict it by developing clinical models predictive of recurrence, which, until now, they only have a very limited role.
Previous data collected by our working group show important differences in the behavior of Clostridium difficile infection between the Central University Hospital of Asturias (HUCA) and the University Hospital of Cabueñes (HUCAB), among which the high number of recurrences and failures to conventional treatments in the latter, being necessary even fecal transplantation as a last therapeutic resource.
In 2017, there were 27 patients with Clostridium difficile infection in the HUCAB, of whom 8 (33.3%) relapsed. In 2018, 4 (22.2%) of 18 patients relapsed, three of them more than three times. Analyzing the characteristics of patients with recurrence within the HUCAB during the years 2017-2018, we found that recurrences are significantly more frequent in patients treated with metronidazole, although this is possibly due to the fact that it is the drug used systematically as the first choice, and diagnosed with hepatopathy without differences between the other treatments, which supports the hypothesis that the differences are due more to the behavior of the strain than to the clinical characteristics of the patients.
A higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found. This increase does not seem to be related to underlying diseases, age, sex or predisposing factors classically described in this type of infection. This high rate of recurrence, together with the absence of response to all conventionally used antibiotic treatments, has important repercussions in the morbidity and mortality of patients, in the ecology of the hospital due to the risk of transmission of a strain of major severity and in the high costs associated with an increase in the hospitalization days of these patients, as well as in an eventual transfer of these to other structures specialized in fecal transplantation.
Two hypotheses are proposed to explain the higher frequency reported:
Hypothesis 1. There are alterations of the microbiome in patients with severe recurrences that favor the appearance of these.
Hypothesis 2. The circulating strain in the hospital has intrinsic characteristics that make it more virulent, such as the presence of virulence or multiresistance factors We design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infection at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No relapses | – | Diagnostic Test: microbiome analysisPatients with clostridium difficile infections without relapses |
| Relapsing patiens | – | Diagnostic Test: microbiome analysisPatients with clostridium difficile infections with relapses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infeopiction at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021 For the purpose of the study we define case as a patient with C. difficile infection demonstrated in stool samples in presence of compatible gastrointestinal diseases. We define a positive microbiological result if the patient had a determination of toxin plus GDH positives or there is colonoscopy or histopathological evidence of pseudomembranous colitis. The discordant cases will be confirmed by PCR, and we consider that infection exits if it is positive Recurrence will be considered if the patient presents a new episode of C. difficile infection if he / she presents again compatible clinical and positive microbiological diagnosis in the 60 days following the previous episode.
Key inclusion criteria (2 listed)
- Diagnosed of C. difficile infection
- Age older than 18 years old.
Key exclusion criteria (3 listed)
- Failing to meet the inclusion criteria
- If the positive microbiological results were not associated with clinical features of gastrointestinal infection.
- Patients with incomplete data.
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 |
|---|---|---|
| microbiome analysisgut microbiome composition of C. difficile infected patients with relapsing (basal, at the end of first treatment, at the begin of the relapses and at four and twelve weeks after definitive treatment) and non-relapsing ( basal and four and twelve week after treatment) , will be analyzed. | Diagnostic test | No relapses, Relapsing patiens |
Primary outcome
Identification of risk factors
Time frame: 12 weeks
identify risk factors linked to the appearance of serious relapses in patients infected with Clostridium difficile, with special emphasis on the relationship between changes in the patient's microbiota and the appearance of these recurrences.
2 secondary outcomes
Characterization of the circulating strain: profile of resistance, ribotype and presence of virulence factors.
Time frame: 16 weeks
Study of the alterations in the microbiome of Clostridium difficile-infected patients with relapsing and non-relapsing.
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 30055221Bradley CW, Burdett H, Holden KL, Holden E, Garvey MI. How do we define recurrence in Clostridium difficile infection? J Hosp Infect. 2019 Jun;102(2):171-173. doi: 10.1016/j.jhin.2018.07.026. Epub 2018 Jul 26. No abstract available.
- Background: PubMed 29132405Pakpour S, Bhanvadia A, Zhu R, Amarnani A, Gibbons SM, Gurry T, Alm EJ, Martello LA. Identifying predictive features of Clostridium difficile infection recurrence before, during, and after primary antibiotic treatment. Microbiome. 2017 Nov 13;5(1):148. doi: 10.1186/s40168-017-0368-1.
- Background: PubMed 29336928Petrosillo N. Tackling the recurrence of Clostridium difficile infection. Med Mal Infect. 2018 Feb;48(1):18-22. doi: 10.1016/j.medmal.2017.10.007. Epub 2018 Jan 12.
- Background: PubMed 29964230Falcone M, Tiseo G, Iraci F, Raponi G, Goldoni P, Delle Rose D, Santino I, Carfagna P, Murri R, Fantoni M, Fontana C, Sanguinetti M, Farcomeni A, Antonelli G, Aceti A, Mastroianni C, Andreoni M, Cauda R, Petrosillo N, Venditti M. Risk factors for recurrence in patients with Clostridium difficile infection due to 027 and non-027 ribotypes. Clin Microbiol Infect. 2019 Apr;25(4):474-480. doi: 10.1016/j.cmi.2018.06.020. Epub 2018 Jun 28.
- Background: PubMed 30400734Song JH, Kim YS. Recurrent Clostridium difficile Infection: Risk Factors, Treatment, and Prevention. Gut Liver. 2019 Jan 15;13(1):16-24. doi: 10.5009/gnl18071.
- Background: PubMed 29903711Ford DC, Schroeder MC, Ince D, Ernst EJ. Cost-effectiveness analysis of initial treatment strategies for mild-to-moderate Clostridium difficile infection in hospitalized patients. Am J Health Syst Pharm. 2018 Aug 1;75(15):1110-1121. doi: 10.2146/ajhp170554. Epub 2018 Jun 14.
- Background: PubMed 30350418Tieu JD, Williams RJ 2nd, Skrepnek GH, Gentry CA. Clinical outcomes of fidaxomicin vs oral vancomycin in recurrent Clostridium difficile infection. J Clin Pharm Ther. 2019 Apr;44(2):220-228. doi: 10.1111/jcpt.12771. Epub 2018 Oct 22.
- Background: PubMed 23748655Asensio A, Bouza E, Grau S, Rubio-Rodriguez D, Rubio-Terres C. [Cost of Clostridium difficile associated diarrhea in Spain]. Rev Esp Salud Publica. 2013 Jan-Feb;87(1):25-33. doi: 10.4321/S1135-57272013000100004. Spanish.
- Individual participant dataSharing planned: No
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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.
Azucena Rodriguez Guardado, MdPhd principal investigator
Hospital Universitario de Cabuenes
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by Hospital Universitario de Cabuenes.
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 3 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Azucena Rodriguez Guardado, Md Phd (+34985185000 ext. 72442, azucenarguardado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of risk factors (time frame: 12 weeks). 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 NCT04259931, which also lists 8 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 7 Feb 2020.