Nosocomial InfectionsMOSERNCT01346735
Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)
An observational study of Nosocomial Infections, run by Indian Society of Critical Care Medicine at 1 site in India.
Trial summary
Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nosocomial Infections
- How many people
- 381 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2011to Oct 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients
Who may be able to join
- ICU stay >48 hours
- One of the following infections (VAP, CAUTI or CRBSI)
Who cannot join
- Index ICU stay < 48 hours
- Re-admissions to the ICU within the same hospitalization
- Age >18 years or <70 years
- Known HIV serology positivity
- Burns
- Solid organ or Bone-marrow transplant
- No ICU-acquired infections (specifically VAP, CAUTI and CRBSI)
Trial locations and contacts
1 site in 1 country.
About this study
Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. This can potentially lead to inadequate, inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian setting. Hence in this multi-center observational study, we seek to:
- To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India
- To explore the microbiology, resistance and treatment patterns of these infections
- Conditions
- Nosocomial Infections
- Being tested
- No intervention
- Keywords
- Ventilator associated pneumonia, Catheter related blood stream infection, Catheter associated urinary tract infection, ICU-related infections (VAP, CAUTI and CRBSI), India
- Medical subject headings
- Cross Infection, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| ICU infections | Infections acquired during the ICU stay Receives: Other: No intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionsStudies 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
- Prospective
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Society of Critical Care Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ramesh Venkataraman, Indian Society of Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346735
- Sponsor's protocol ID
- ISCCM1
- Acronym
- MOSER
- Status last verified
- Aug 2016
- First submitted
- 2 May 2011
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)
- ClinicalTrials.gov ID
- NCT01346735
- Acronym / sponsor ID
- MOSER / ISCCM1
- Conditions
- Nosocomial Infections
- Keywords
- Ventilator associated pneumonia, Catheter related blood stream infection, Catheter associated urinary tract infection, ICU-related infections (VAP, CAUTI and CRBSI), India
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Indian Society of Critical Care MedicineUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 May 2011 (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.
Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. This can potentially lead to inadequate, inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian setting. Hence in this multi-center observational study, we seek to:
- To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India
- To explore the microbiology, resistance and treatment patterns of these infections
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU infections | – | Other: No interventionInfections acquired during the ICU stay |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients
Key inclusion criteria (2 listed)
- ICU stay >48 hours
- One of the following infections (VAP, CAUTI or CRBSI)
Key exclusion criteria (7 listed)
- Index ICU stay < 48 hours
- Re-admissions to the ICU within the same hospitalization
- Age >18 years or <70 years
- Known HIV serology positivity
- Burns
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 |
|---|---|---|
| No intervention | Other | ICU infections |
Primary outcome
Not reported in the source record.
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 1 Sep 2016.
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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.
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 Nosocomial Infections, run by Indian Society of Critical Care Medicine at 1 site in India.
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 7 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 1 Sep 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 India. 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 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.
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 1 Sep 2016.