NeutropeniaMedIsoNCT01669005
The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies
An observational study of Neutropenia, run by Centre Hospitalier Universitaire Vaudois.
Trial summary
Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neutropenia
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2008
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in the bone marrow transplant unit in the study period
Who may be able to join
- patients aged ≥18 years
- autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed
Who cannot join
- No blood samples were taken
About this study
Official title: Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study
Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.
Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for multiplex PCR at admission and 3x/week thereafter until discharge or recovery from neutropenia
- Conditions
- Neutropenia
- Keywords
- neutropenia, multiplex PCR, infection
- Medical subject headings
- Neutropenia, 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 |
|---|---|---|
| Bone marrow transplant unit patients | hospitalized patients in the bone marrow transplant unit for an autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Principal investigator, Andrej Trampuz, Centre Hospitalier Universitaire Vaudois
- Investigators
- Andrej Trampuz, MD, Study director, University Hospital Lausanne, SwitzerlandChristina Orasch, MD, Principal investigator, University Hospital Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669005
- Sponsor's protocol ID
- EK 324/06
- Acronym
- MedIso
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study
- ClinicalTrials.gov ID
- NCT01669005
- Acronym / sponsor ID
- MedIso / EK 324/06
- Conditions
- Neutropenia
- Keywords
- neutropenia, multiplex PCR, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Aug 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.
Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.
Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for multiplex PCR at admission and 3x/week thereafter until discharge or recovery from neutropenia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone marrow transplant unit patients | – | –hospitalized patients in the bone marrow transplant unit for an autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in the bone marrow transplant unit in the study period
Key inclusion criteria (2 listed)
- patients aged ≥18 years
- autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed
Key exclusion criteria (1 listed)
- No blood samples were taken
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
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 20 Aug 2012.
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Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
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Not yet recruitingPhase 2
A Study to Investigate the Safety and Tolerability of Granulocyte-colony Stimulating Factor (G-CSF) Dosage Reduction in Mavorixafor-treated Participants With Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders
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Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
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.
Andrej Trampuz, MD study director
University Hospital Lausanne, Switzerland
Christina Orasch, MD principal investigator
University Hospital Lausanne, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia, run by Centre Hospitalier Universitaire Vaudois.
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 20 Aug 2012. 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.
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 20 Aug 2012.