Clostridium DifficileNCT03586206
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
An observational study of Clostridium Difficile and Clostridium Difficile Infection, run by Roma Tre University.
Trial summary
To assess the association between Clostridium difficile (CD) toxins' serum levels and the grade of Clostridium difficile infection (CDI) severity/failure to CDI treatment and rate of recurrence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile, Clostridium Difficile Infection
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2018to 31 Dec 2020
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 45 consecutive patients with documented CDI infection, including:
- 20 with mild-moderate CDI
- 20 with severe CDI
- 5 with severe complicated/fulminant CDI, according to ESCMID definition.
Who cannot join
None listed.
About this study
To assess the association between Clostridium difficile (CD) toxins' serum levels and the grade of Clostridium difficile infection (CDI) severity/failure to CDI treatment and rate of recurrence. Furthermore, the kinetics of CD toxins in serum of CDI patients undergoing anti-CDI treatment, as well as the relationship between serum toxins levels and length of CDI diarrhea will be evaluated.
Read the detailed description
Background. C. difficile frequently induces toxemia, however due to limited sensitivity of existing diagnostic tools, it goes undetected in common clinical practice. Although undetected, Clostridium difficile infection (CDI)-induced toxemia is often experienced, and this explains the systemic complications of life-threatening CDI cases. Until recently, although the pathogenetic process was already known, the phenomenon of extraintestinal damage caused by C. difficile toxins has been undervalued. However, a recent study has proven toxemia in humans. In the last 5 years, animal studies have proven the presence of C. difficile toxins in several body fluids, toxemia correlating with systemic disease and mortality. However, although toxin A (TcdA) and B (TcdB) are the primary virulence factors responsible for C. difficile-associated diarrhea and inflammation, only three toxemia-positive cases (two adults and one child) have been reported so far in humans. The explanation for such a low number of toxemia-positive cases may be the lack of sensitive toxins detection method.
Objectives.
- To assess the association between CD toxins' serum levels and grade of CDI severity/failure to CDI treatment and rate of recurrence.
- To evaluate the kinetics of CD toxins in serum of CDI patients undergoing anti-CDI treatment.
- To assess the relationship between serum toxins levels and length of CDI diarrhoea.
Study design. Prospective observational study on the measurement of serum levels of CD toxins in patients with CDI.
In order to assess the relationship between C difficile toxins' serum level and severity and recurrence rate, 45 consecutive patients with documented CDI infection will be studied, including 20 with mild-moderate CDI, 20 with severe CDI, and 5 with severe complicated/fulminant CDI according to ESCMID definition. For each patient three determination of serum toxins will be performed at time 0 (before initiation of anti-CDI treatment), 4d, 10d.
Patients will be followed up to three months after the recovery from the first episode.
The serum toxins' levels will be correlated to severity and to the first recurrence.
Methodology
- Serum samples Peripheral blood will be obtained from each healthy and CDI subjects. Serum will be separated from the peripheral blood sample by centrifugation at 700 g for 5 min, and then stored at -20°C until measurement.
- Serum IgG depletion It has been reported that neutralizing antibodies present in human serum, mostly IgG, are able to mask the C. difficile toxins levels in serum. Total IgG in serum samples will be removed with Protein A beads (Santa Cruz Biotechnology, Santa Cruz, CA, USA). Two milliliters of human serum sample will be applied to an equal volume of protein A beads resuspended in binding buffer, and incubated at room temperature under rotary agitation for 1 h. The IgG bound to the Protein A beads will be removed by centrifugation. The proper IgG depletion will be evaluated by western blot.
- SDS-PAGE and western blot IgG-purified sera will be resolved by 10% SDS-PAGE and transferred onto PVDF membranes (Bio-Rad, Hercules, CA, USA). After blocking for 1 h at room temperature (RT) with 5% non-fat dry milk (w/v) and 0.5% Tween-20 (v/v) dissolved in PBS, membranes will be probed with anti-human IgG primary antibody (anti-Human IgG, γ-chain specific antibody; Sigma-Aldrich, St. Louis, MO, USA), at 4°C overnight. Membranes will be then incubated for 1 h at RT with the HRP-conjugated secondary antibody (Bio-Rad). Proteins will be visualized by the enhanced chemiluminescence (ECL) detection system (Bio-Rad) and images will be acquired using the Chemidoc System (Bio-Rad).
- Dot-blot d1. Standard reference The dot-blot condition set-up for the evaluation of C. difficile TcdA and TcdB levels in the human serum samples will be performed as follows. Recombinant TcdA and TcdB (Enzo Life Science, Farmingdale, NY) will be dissolved in deionized water to obtain 0.2 mg/mL stock solutions. Toxins will be serially diluted from 0.001 pg to 1000 pg in PBS at pH 7.4. Ten microliters of diluted TcdA and TcdB will be blotted in triplicate into EMD Millipore MultiScreen™ 96-Well Assay Plates (Fisher Scientific, Waltham, MA, USA). After 10 min of drying, the membrane will be immersed in 2% BSA-PBS (w/v) buffer for 1 h at 37 °C. The membrane will be washed with PBS containing 0.05% Tween 20, at pH 7.2) for 2 min and immersed in anti-C. difficile TcdA and anti-C.difficile TcdB (Abcam) primary antibodies (recognizing the native proteins), for 1 h at RT. The proper dilution of the anti-TcdA and -TcdB antibodies will be tested, according to manufacturer's instructions. The membrane will be then washed for 2 min and the dots corresponding to the increasing concentrations of TcdA and TcdB will be visualized by ECL and acquired by the Chemidoc system. The intensities of the colored blots will be considered as a standard reference to evaluate the minimum concentration of TcdA and TcdB that can be detected by this method. d2. Set-up of the volume and dilution of human serum to be used The sensitivity of the method will be assessed using toxemia-negative spiked human serum samples freshly prepared by adding recombinant toxins (positive control). The quantity of recombinant TcdA and TcdB to be added to the spiked serum will be chosen on the basis of results obtained in the previous section (d1). This will allow determining: (i) the minimal concentration of TcdA and TcdB that can be detected by the dot-blot method when diluted in the human serum; and (ii) the proper volume and dilution of the human serum to be added to each well of the MultiScreen™ 96-well assay plates. d3. Dot blot on the serum samples of CDI patients to determine toxins levels Human sera derived from CDI patients will be IgG-depleted (see section b) and then spotted trice into the MultiScreen™ 96-well assay plates. The dot-blot method described in section d1 will be applied to determine and semi-quantify TcdA and TcdB levels, using the TcdA and TcdB standard curves.
- Keywords
- Clostridium difficile, toxins, serum, infection
- Medical subject headings
- Clostridium Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild-moderate C.difficile infection | Not described | |
| severe C.difficile infection | Not described | |
| severe complicated/fulminant C.difficile infection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Setup of the method.
Mann-Whitney U-tests will be used to compare the intensity of each triplicate chemiluminescent spot of the CDI serum tested with the TcdA and TcdB standard curves, and to compare the intensities of the chemiluminescent spots of CDI patients with those of normal subjects. Quantitative variables will be expressed as the median and IQR.
Measured: For each patient, the change of serum toxins levels after 4 and 10 days from the initation of anti-CDI treatment will be compared to levels before initation of anti-CDI treatment.
Validation on the proposed method
According to ESCMID guidelines, our method will be compared with reference tests that are defined as the best tests currently available for CDI diagnosis (i.e., cell cytotoxicity neutralization assay (CCNA) and toxigenic culture (TC)). As both these reference tests detect different things, and because of this they will not necessarily agree with each other in all samples, results for each reference test will be analysed separately.
Measured: The proposed method will be compared with reference tests evaluating change of serum toxins levels after 4 and 10 days from the initiation of anti-CDI treatment with levels before initiation of anti-CDI treatment.
Performance of the proposed method
The performance of our method will be assessed using the receiver operating characteristic (ROC) curve and the area under the curve (AUC). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the prediction rule of poor outcome will be calculated. Validity values will be calculated with a 95% CI following an exact binomial distribution. A P value <0.05 will be considered significant
Measured: The evaluation of the performance of the proposed method will be assed by evaluating the change of toxins levels from baseline levels (time 0) at 4 and 10 days from the initiation of anti-CDI treatment.
Correlation of toxins kinetics and CDI severity
Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated by one-way analysis of variance (ANOVA) with CDI severity (defined according to ESCMID guidelines)
Measured: Determination of serum toxin kinetics will be evaluated by the change from baseline levels (time 0) at 4 and 10 days from the initiation of anti-CDI treatment. For recurrence rate, the follow up will be of 30 days after cessation of diarrhea.
Correlation between toxins levels and the duration of diarrhea
Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated with the duration of diarrhea. A multivariate logistic regression model will be used. The odds ratio (OR) and 95% confidence interval (CI) will be calculated. The Spearman correlation coefficients and Wilcoxon rank sum tests will be used to determine whether TcdA and TcdB levels could be associated with the duration of diarrhea.
Measured: Determination of serum toxin kinetics will be evaluated by the change from baseline levels (time 0) at 4 and 10 days from the initiation of anti-CDI treatment.
Correlation between toxins levels and the recurrence rate
Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated with the recurrence rate. A multivariate logistic regression model will be used to assess predictors of poor outcome of CDI. The odds ratio (OR) and 95% confidence interval (CI) will be calculated.
The Spearman correlation coefficients and Wilcoxon rank sum tests will be used to determine whether TcdA and TcdB levels could be associated with the recurrence rate.
Measured: Determination of serum toxin kinetics will be evaluated by the change from baseline levels (time 0) at 30 days from the cessation of diarrhea.
Correlation between toxins levels and mortality rate
Survival curves comparing the mortality with toxin(s) levels will be calculated using the Kaplan-Meier method and tested for significance using the log-rank test. P<0.05 will be considered statistically significant.
Measured: Time-to-Event measure: toxin levels versus mortality rate, from date of patient enrollment to the date of death from any cause assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start15 Sep 2018 (estimated)
- Primary completion15 Sep 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roma Tre University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586206
- Sponsor's protocol ID
- MISP57289
- Status last verified
- May 2018
- First submitted
- 28 May 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
- ClinicalTrials.gov ID
- NCT03586206
- Acronym / sponsor ID
- MISP57289
- Keywords
- Clostridium difficile, toxins, serum, infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Roma Tre UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Sep 2018 (estimated)
- Primary completion
- 15 Sep 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Jul 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.
To assess the association between Clostridium difficile (CD) toxins' serum levels and the grade of Clostridium difficile infection (CDI) severity/failure to CDI treatment and rate of recurrence. Furthermore, the kinetics of CD toxins in serum of CDI patients undergoing anti-CDI treatment, as well as the relationship between serum toxins levels and length of CDI diarrhea will be evaluated.
Detailed description
Background. C. difficile frequently induces toxemia, however due to limited sensitivity of existing diagnostic tools, it goes undetected in common clinical practice. Although undetected, Clostridium difficile infection (CDI)-induced toxemia is often experienced, and this explains the systemic complications of life-threatening CDI cases. Until recently, although the pathogenetic process was already known, the phenomenon of extraintestinal damage caused by C. difficile toxins has been undervalued. However, a recent study has proven toxemia in humans. In the last 5 years, animal studies have proven the presence of C. difficile toxins in several body fluids, toxemia correlating with systemic disease and mortality. However, although toxin A (TcdA) and B (TcdB) are the primary virulence factors responsible for C. difficile-associated diarrhea and inflammation, only three toxemia-positive cases (two adults and one child) have been reported so far in humans. The explanation for such a low number of toxemia-positive cases may be the lack of sensitive toxins detection method.
Objectives.
- To assess the association between CD toxins' serum levels and grade of CDI severity/failure to CDI treatment and rate of recurrence.
- To evaluate the kinetics of CD toxins in serum of CDI patients undergoing anti-CDI treatment.
- To assess the relationship between serum toxins levels and length of CDI diarrhoea.
Study design. Prospective observational study on the measurement of serum levels of CD toxins in patients with CDI.
In order to assess the relationship between C difficile toxins' serum level and severity and recurrence rate, 45 consecutive patients with documented CDI infection will be studied, including 20 with mild-moderate CDI, 20 with severe CDI, and 5 with severe complicated/fulminant CDI according to ESCMID definition. For each patient three determination of serum toxins will be performed at time 0 (before initiation of anti-CDI treatment), 4d, 10d.
Patients will be followed up to three months after the recovery from the first episode.
The serum toxins' levels will be correlated to severity and to the first recurrence.
Methodology
- Serum samples Peripheral blood will be obtained from each healthy and CDI subjects. Serum will be separated from the peripheral blood sample by centrifugation at 700 g for 5 min, and then stored at -20°C until measurement.
- Serum IgG depletion It has been reported that neutralizing antibodies present in human serum, mostly IgG, are able to mask the C. difficile toxins levels in serum. Total IgG in serum samples will be removed with Protein A beads (Santa Cruz Biotechnology, Santa Cruz, CA, USA). Two milliliters of human serum sample will be applied to an equal volume of protein A beads resuspended in binding buffer, and incubated at room temperature under rotary agitation for 1 h. The IgG bound to the Protein A beads will be removed by centrifugation. The proper IgG depletion will be evaluated by western blot.
- SDS-PAGE and western blot IgG-purified sera will be resolved by 10% SDS-PAGE and transferred onto PVDF membranes (Bio-Rad, Hercules, CA, USA). After blocking for 1 h at room temperature (RT) with 5% non-fat dry milk (w/v) and 0.5% Tween-20 (v/v) dissolved in PBS, membranes will be probed with anti-human IgG primary antibody (anti-Human IgG, γ-chain specific antibody; Sigma-Aldrich, St. Louis, MO, USA), at 4°C overnight. Membranes will be then incubated for 1 h at RT with the HRP-conjugated secondary antibody (Bio-Rad). Proteins will be visualized by the enhanced chemiluminescence (ECL) detection system (Bio-Rad) and images will be acquired using the Chemidoc System (Bio-Rad).
- Dot-blot d1. Standard reference The dot-blot condition set-up for the evaluation of C. difficile TcdA and TcdB levels in the human serum samples will be performed as follows. Recombinant TcdA and TcdB (Enzo Life Science, Farmingdale, NY) will be dissolved in deionized water to obtain 0.2 mg/mL stock solutions. Toxins will be serially diluted from 0.001 pg to 1000 pg in PBS at pH 7.4. Ten microliters of diluted TcdA and TcdB will be blotted in triplicate into EMD Millipore MultiScreen™ 96-Well Assay Plates (Fisher Scientific, Waltham, MA, USA). After 10 min of drying, the membrane will be immersed in 2% BSA-PBS (w/v) buffer for 1 h at 37 °C. The membrane will be washed with PBS containing 0.05% Tween 20, at pH 7.2) for 2 min and immersed in anti-C. difficile TcdA and anti-C.difficile TcdB (Abcam) primary antibodies (recognizing the native proteins), for 1 h at RT. The proper dilution of the anti-TcdA and -TcdB antibodies will be tested, according to manufacturer's instructions. The membrane will be then washed for 2 min and the dots corresponding to the increasing concentrations of TcdA and TcdB will be visualized by ECL and acquired by the Chemidoc system. The intensities of the colored blots will be considered as a standard reference to evaluate the minimum concentration of TcdA and TcdB that can be detected by this method. d2. Set-up of the volume and dilution of human serum to be used The sensitivity of the method will be assessed using toxemia-negative spiked human serum samples freshly prepared by adding recombinant toxins (positive control). The quantity of recombinant TcdA and TcdB to be added to the spiked serum will be chosen on the basis of results obtained in the previous section (d1). This will allow determining: (i) the minimal concentration of TcdA and TcdB that can be detected by the dot-blot method when diluted in the human serum; and (ii) the proper volume and dilution of the human serum to be added to each well of the MultiScreen™ 96-well assay plates. d3. Dot blot on the serum samples of CDI patients to determine toxins levels Human sera derived from CDI patients will be IgG-depleted (see section b) and then spotted trice into the MultiScreen™ 96-well assay plates. The dot-blot method described in section d1 will be applied to determine and semi-quantify TcdA and TcdB levels, using the TcdA and TcdB standard curves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild-moderate C.difficile infection | – | – |
| severe C.difficile infection | – | – |
| severe complicated/fulminant C.difficile infection | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- 45 consecutive patients with documented CDI infection, including:
- 20 with mild-moderate CDI
- 20 with severe CDI
- 5 with severe complicated/fulminant CDI, according to ESCMID definition.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Setup of the method.
Time frame: For each patient, the change of serum toxins levels after 4 and 10 days from the initation of anti-CDI treatment will be compared to levels before initation of anti-CDI treatment.
Mann-Whitney U-tests will be used to compare the intensity of each triplicate chemiluminescent spot of the CDI serum tested with the TcdA and TcdB standard curves, and to compare the intensities of the chemiluminescent spots of CDI patients with those of normal subjects. Quantitative variables will be expressed as the median and IQR.
Validation on the proposed method
Time frame: The proposed method will be compared with reference tests evaluating change of serum toxins levels after 4 and 10 days from the initiation of anti-CDI treatment with levels before initiation of anti-CDI treatment.
According to ESCMID guidelines, our method will be compared with reference tests that are defined as the best tests currently available for CDI diagnosis (i.e., cell cytotoxicity neutralization assay (CCNA) and toxigenic culture (TC)). As both these reference tests detect different things, and because of this they will not necessarily agree with each other in all samples, results for each reference test will be analysed separately.
Performance of the proposed method
Time frame: The evaluation of the performance of the proposed method will be assed by evaluating the change of toxins levels from baseline levels (time 0) at 4 and 10 days from the initiation of anti-CDI treatment.
The performance of our method will be assessed using the receiver operating characteristic (ROC) curve and the area under the curve (AUC). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the prediction rule of poor outcome will be calculated. Validity values will be calculated with a 95% CI following an exact binomial distribution. A P value <0.05 will be considered significant
Correlation of toxins kinetics and CDI severity
Time frame: Determination of serum toxin kinetics will be evaluated by the change from baseline levels (time 0) at 4 and 10 days from the initiation of anti-CDI treatment. For recurrence rate, the follow up will be of 30 days after cessation of diarrhea.
Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated by one-way analysis of variance (ANOVA) with CDI severity (defined according to ESCMID guidelines)
Correlation between toxins levels and the duration of diarrhea
Time frame: Determination of serum toxin kinetics will be evaluated by the change from baseline levels (time 0) at 4 and 10 days from the initiation of anti-CDI treatment.
Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated with the duration of diarrhea. A multivariate logistic regression model will be used. The odds ratio (OR) and 95% confidence interval (CI) will be calculated. The Spearman correlation coefficients and Wilcoxon rank sum tests will be used to determine whether TcdA and TcdB levels could be associated with the duration of diarrhea.
Correlation between toxins levels and the recurrence rate
Time frame: Determination of serum toxin kinetics will be evaluated by the change from baseline levels (time 0) at 30 days from the cessation of diarrhea.
Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated with the recurrence rate. A multivariate logistic regression model will be used to assess predictors of poor outcome of CDI. The odds ratio (OR) and 95% confidence interval (CI) will be calculated. The Spearman correlation coefficients and Wilcoxon rank sum tests will be used to determine whether TcdA and TcdB levels could be associated with the recurrence rate.
Correlation between toxins levels and mortality rate
Time frame: Time-to-Event measure: toxin levels versus mortality rate, from date of patient enrollment to the date of death from any cause assessed up to 12 months.
Survival curves comparing the mortality with toxin(s) levels will be calculated using the Kaplan-Meier method and tested for significance using the log-rank test. P<0.05 will be considered statistically significant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile and Clostridium Difficile Infection, run by Roma Tre University.
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 0 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 13 Jul 2018. 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?
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?
Setup of the method. (time frame: For each patient, the change of serum toxins levels after 4 and 10 days from the initation of anti-CDI treatment will be compared to levels before initation of anti-CDI treatment.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.