FebrileHEMATOCPLUSNCT00913042
Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia
An observational study of Febrile and Neutropenia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile, Neutropenia, Post-chemotherapy
- What is being tested?
- sample blood
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Apr 2009
- 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: Febrile neutropenia post-chemotherapy
Who may be able to join
- age > 18 y
- first episode of febrile neutropenia during a given neutropenic phase
- PMN < 500/mm3, chemotherapy-induced
- fever > 38°C twice, or < 38°3C once
- signed informed consent
Who cannot join
- patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia
Trial locations and contacts
1 site in 1 country.
France1 site
Hematology Department, Paris 12 University Hospital Henri Mondor
Créteil, 94010
About this study
Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures.
The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.
Read the detailed description
Evaluation criteria are 1) proportion of microbiologically documented infections 2) time elapsed from bed side sampling to microbiological diagnostic, in case of positive sample.
The assessed procedures included a large volume of blood, an early incubation made possible by the availability of a culture device in the hematology department, an early warning in case of positive blood culture, bacterial DNA detection in blood, and an early identification of the positive strains and their resistance profile.
We hypothesize that the combination of these different procedures will improve the proportion of microbiologically blood culture from 30 to 45%. One hundred and 20 episodes of febrile neutropenia are necessary to achieve this goal.
- Conditions
- Febrile, Neutropenia, Post-chemotherapy
- Being tested
- sample blood
- Keywords
- Febrile neutropenia, Blood culture, Bacteremia, Bacterial DNA testing
- Medical subject headings
- Fever, Neutropenia, Febrile Neutropenia, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample bloodOther
- Early culture
- Bacterial DNA tests in blood
| Study group | Role | What they receive |
|---|---|---|
| 1 | febrile neutropenia patient Receives: Other: sample blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of microbiologically documented infections
Measured: Day 14 from inclusion
Secondary outcomes (1)
clinical status at the end of hospitalisation
Measured: Day 30 from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FebrileStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Pautas, PH, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913042
- Sponsor's protocol ID
- CRC 06021
- Acronym
- HEMATOCPLUS
- Status last verified
- Apr 2009
- First submitted
- 2 Jun 2009
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT00913042
- Acronym / sponsor ID
- HEMATOCPLUS / CRC 06021
- Conditions
- Febrile, Neutropenia, Post-chemotherapy
- Keywords
- Febrile neutropenia, Blood culture, Bacteremia, Bacterial DNA testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 3 Jun 2009 (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.
Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures.
The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.
Detailed description
Evaluation criteria are 1) proportion of microbiologically documented infections 2) time elapsed from bed side sampling to microbiological diagnostic, in case of positive sample.
The assessed procedures included a large volume of blood, an early incubation made possible by the availability of a culture device in the hematology department, an early warning in case of positive blood culture, bacterial DNA detection in blood, and an early identification of the positive strains and their resistance profile.
We hypothesize that the combination of these different procedures will improve the proportion of microbiologically blood culture from 30 to 45%. One hundred and 20 episodes of febrile neutropenia are necessary to achieve this goal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: sample bloodfebrile neutropenia patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Febrile neutropenia post-chemotherapy
Key inclusion criteria (5 listed)
- age > 18 y
- first episode of febrile neutropenia during a given neutropenic phase
- PMN < 500/mm3, chemotherapy-induced
- fever > 38°C twice, or < 38°3C once
- signed informed consent
Key exclusion criteria (1 listed)
- patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia
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 |
|---|---|---|
| sample blood* Early culture * Bacterial DNA tests in blood | Other | 1 |
Primary outcome
proportion of microbiologically documented infections
Time frame: Day 14 from inclusion
1 secondary outcome
clinical status at the end of hospitalisation
Time frame: Day 30 from inclusion
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 26 Jul 2012.
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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.
Cécile Pautas, PH principal investigator
Henri Mondor University Hospital
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 Febrile and Neutropenia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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 26 Jul 2012. 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 France. 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.
What does the primary outcome measure?
proportion of microbiologically documented infections (time frame: Day 14 from inclusion). 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 26 Jul 2012.