Clostridium Difficile InfectionNCT02327520
Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study
An observational study of Clostridium Difficile Infection, run by King Chulalongkorn Memorial Hospital.
Trial summary
The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). 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?
- Colitis with CDI treatment
- How many people
- 204,666 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with the diagnosis of Clostridium difficile (ICD10-A07) with age of more than 18 years were included.
Who may be able to join
- The patients with the diagnosis of Clostridium difficile (ICD10-A07)
- Age of more than 18 years.
Who cannot join
- Data incompleted
About this study
Official title: The Burden of Clostridium Difficile Infection in Thai Population: the First Report in Southeast Asia by 2010 Nationwide Study
The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Colitis with CDI treatment
- Keywords
- Clostridium difficile infection, burden, nationwide study, South East Asia, Thailand, Epidemiology, Outcome Assessment (Health Care) [N04.761.559.590]
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colitis with CDI treatmentOther
All patients will be treated with standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Colitis with CDI | Patients who diagnosed with CDI will be analysed Receives: Other: Colitis with CDI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate and length of hospital stay in CDI during admission
Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Hospital charge of CDI
Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 204,666 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
- Investigators
- Rapat Pittayanon, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327520
- Sponsor's protocol ID
- RP009
- Status last verified
- Dec 2014
- First submitted
- 22 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of Clostridium Difficile Infection in Thai Population: the First Report in Southeast Asia by 2010 Nationwide Study
- ClinicalTrials.gov ID
- NCT02327520
- Acronym / sponsor ID
- RP009
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile infection, burden, nationwide study, South East Asia, Thailand, Epidemiology, Outcome Assessment (Health Care) [N04.761.559.590]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204,666 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Dec 2014 (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 authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colitis with CDI | – | Other: Colitis with CDI treatmentPatients who diagnosed with CDI will be analysed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with the diagnosis of Clostridium difficile (ICD10-A07) with age of more than 18 years were included.
Key inclusion criteria (2 listed)
- The patients with the diagnosis of Clostridium difficile (ICD10-A07)
- Age of more than 18 years.
Key exclusion criteria (1 listed)
- Data incompleted
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 |
|---|---|---|
| Colitis with CDI treatmentAll patients will be treated with standard treatment | Other | Colitis with CDI |
Primary outcome
Death rate and length of hospital stay in CDI during admission
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.
Hospital charge of CDI
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of hospital stay(LOS), mortality rate and hospital charge were used as the indicators for evaluating the burden of CDI.
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 30 Dec 2014.
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.
Rapat Pittayanon, MD principal investigator
King Chulalongkorn Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by King Chulalongkorn Memorial Hospital.
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 30 Dec 2014. 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?
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?
Death rate and length of hospital stay in CDI during admission (time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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?
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 30 Dec 2014.