Clostridium DifficileDAISYNCT01533844
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
An observational study of Clostridium Difficile, run by Astellas Pharma Europe B.V. at 9 sites in 4 countries.
Trial summary
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be… Read more about this study
- Who is it for?
- Ages Up to 27 days
- Conditions the study is for
- Clostridium Difficile
- How many people
- 1 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Mar 2012to Sep 2014
- 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 Up to 27 days
- All sexes
- No healthy volunteers
- Child
Study population: Term neonates less than 28 days of age at enrollment, referred to healthcare professionals due to suspected C Difficile Associated Disease (CDAD).
Who may be able to join
- Subject is suffering from diarrhea or other signs or symptoms consistent with CDAD (as described in section 5.2.3)
- Presence of either toxin A or B (or both) of C. difficile in the stool within 24 hours prior to enrollment using the C. difficile Quik Chek Complete® diagnostic test, provided by the sponsor
Who cannot join
- Subject will be excluded from participation if any of the following apply:
- Preterm neonates
- Negative C. difficile toxin test
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Germany3 sites
Site: 4902
Erlangen, 91054
Site: 4904
Hanover, 30625
Site: 4901
Munich, 80337
Spain3 sites
Site: 3403
Granada, 18014
Site: 3402
Madrid, 28046
Site: 3401
Valencia, 46026
About this study
Official title: An Observational, Non-interventional Study to Determine the Role of Clostridium Difficile in the Pathogenesis of Disease Observed in Neonates and to Investigate the Feasibility of a Potential Study to Evaluate Safety, Efficacy and Pharmacokinetics of Fidaxomicin Oral Suspension in Neonates With Clostridium Difficile Associated Disease (CDAD)
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
- Conditions
- Clostridium Difficile
- Keywords
- CDAD, Neonates, Clostridium difficile
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 |
|---|---|---|
| Neonates | Neonates with CDAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of a potential interventional study with fidaxomicin
The incidence and clinical aspects of clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Terminated due to the fact that the required number of trial subjects was not met.
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
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533844
- Sponsor's protocol ID
- 2819-CL-0204
- Acronym
- DAISY
- Status last verified
- Mar 2015
- First submitted
- 13 Feb 2012
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Non-interventional Study to Determine the Role of Clostridium Difficile in the Pathogenesis of Disease Observed in Neonates and to Investigate the Feasibility of a Potential Study to Evaluate Safety, Efficacy and Pharmacokinetics of Fidaxomicin Oral Suspension in Neonates With Clostridium Difficile Associated Disease (CDAD)
- ClinicalTrials.gov ID
- NCT01533844
- Acronym / sponsor ID
- DAISY / 2819-CL-0204
- Conditions
- Clostridium Difficile
- Keywords
- CDAD, Neonates, Clostridium difficile
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to the fact that the required number of trial subjects was not met.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | –Neonates with CDAD |
Who may qualify
- Ages
- Up to 27 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term neonates less than 28 days of age at enrollment, referred to healthcare professionals due to suspected C Difficile Associated Disease (CDAD).
Key inclusion criteria (2 listed)
- Subject is suffering from diarrhea or other signs or symptoms consistent with CDAD (as described in section 5.2.3)
- Presence of either toxin A or B (or both) of C. difficile in the stool within 24 hours prior to enrollment using the C. difficile Quik Chek Complete® diagnostic test, provided by the sponsor
Key exclusion criteria (3 listed)
- Preterm neonates
- Negative C. difficile toxin test
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
To determine the feasibility of a potential interventional study with fidaxomicin
Time frame: 40 days
The incidence and clinical aspects of clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
Results and safety
The study was stopped early (reason given: Terminated due to the fact that the required number of trial subjects was not met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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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.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile, run by Astellas Pharma Europe B.V. at 9 sites in 4 countries.
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: stopped early, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Spain, France, Netherlands. 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 was stopped early (reason given: Terminated due to the fact that the required number of trial subjects was not met.). 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?
To determine the feasibility of a potential interventional study with fidaxomicin (time frame: 40 days). 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 4 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.