Clostridium Difficile InfectionNCT02223715

Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

An observational study of Clostridium Difficile Infection, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease. Read more about this study

Who is it for?: Any age
Conditions the study is for: Clostridium Difficile Infection
What is being tested?: CDI Pts
How many people: 600 participants
Where: 1 siteJapan
Study dates: Mar 2014to Jan 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with a confirmed diagnosis of CDI(C. difficile infection) who willing to provide informed consent and/or informed assent or data release, according to local regulation.

Who may be able to join

Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC
Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations

Who cannot join

Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kanto Region

Other trials in Japan

About this study

Official title: A Prospective Study to Characterize the Management and Outcome of Clostridium Difficile Infection （CDI) in Asian Pacific Countries

The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease.

Conditions: Clostridium Difficile Infection
Being tested: CDI Pts
Medical subject headings: Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CDI PtsOther

Study groups in NCT02223715
Study group	Role	What they receive
CDI		Not described Receives: Other: CDI Pts

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Demographics
Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.
Measured: At the study at the time of CDI diagnosis enrollment
Status at the End of CDI Episode
The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.
Measured: From the time of CDI diagnosis to the end of the treatment

Secondary outcomes (2)

Clinical Complication
This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected.
Measured: From the time of CDI diagnosis to recovery or recurrence
Recurrence or Not After 2 Months Follow-up
The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment.
Unknown includes patient lost, data missing
Measured: From the time of CDI diagnosis to 2 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Jan 2015

First posted22 Aug 2014 (estimated)
Study startMar 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02223715
Sponsor's protocol ID: 341-12-003
Status last verified: Aug 2016
First submitted: 22 Apr 2014
Last updated: 17 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection

All Clostridium Difficile Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study to Characterize the Management and Outcome of Clostridium Difficile Infection （CDI) in Asian Pacific Countries
ClinicalTrials.gov ID: NCT02223715
Acronym / sponsor ID: 341-12-003
Conditions: Clostridium Difficile Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 22 Aug 2014 (estimated)
Results: Posted 17 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
CDI	–	Other: CDI Pts

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with a confirmed diagnosis of CDI(C. difficile infection) who willing to provide informed consent and/or informed assent or data release, according to local regulation.

Key inclusion criteria (2 listed)

Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC
Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations

Key exclusion criteria (1 listed)

Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.

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
CDI Pts	Other	CDI

Primary outcome

Patient Demographics
Time frame: At the study at the time of CDI diagnosis enrollment
Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.
Status at the End of CDI Episode
Time frame: From the time of CDI diagnosis to the end of the treatment
The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.

2 secondary outcomes

Clinical Complication
Time frame: From the time of CDI diagnosis to recovery or recurrence
Recurrence or Not After 2 Months Follow-up
Time frame: From the time of CDI diagnosis to 2 months follow-up

Results and safety

Results posted to the registry on 17 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clostridium Difficile Infection	600	496

Primary outcome: Patient Demographics

Time frame: At the study at the time of CDI diagnosis enrollment. Number. Unit: participants

Measure	Medical History n = 600
Myocardial infarction	54
Congestive heart failure	46
Cerebrovascular disease	63
Peripheral vascular disease	29
Chronic pulmonary disease	57
Connective tissue disease	72
Peptic ulcer disease	69
Liver disease	76

Population analysed: Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.

Primary outcome: Status at the End of CDI Episode

Time frame: From the time of CDI diagnosis to the end of the treatment. Number. Unit: participants

Measure	Status at the End of CDI Episode n = 600
Lost to follow-up	7
Resolved	562
Death	31

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clostridium Difficile Infection	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Clostridium Difficile Infection

Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Clostridium Difficile Infection, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 1 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 17 Oct 2016. 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 Japan. 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?

Yes. Results are posted in the registry (first posted 17 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient Demographics (time frame: At the study at the time of CDI diagnosis enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02223715.

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 17 Oct 2016.