InfectionsNCT00930267
Infections in Pediatric Cancer Patients
An observational study of Infections, run by Hadassah Medical Organization.
Trial summary
A prospective epidemiological study conducted in pediatric hematology oncology center in Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during chemotherapy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Infections
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy
Who may be able to join
- Pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy
Who cannot join
- No exclusions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epidemiology and Etiology of Infections in Pediatric Cancer Patients: A Prospective Study
A prospective epidemiological study conducted in pediatric hematology oncology center in Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during chemotherapy.
In each event of febrile episode during chemotherapy, the following data will be collected using a patient data form and computerized software.
Read more
Demographic data: age, gender, ethnicity. Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.
Imaging data Microbiological data Outcome The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.
- Conditions
- Infections
- Keywords
- fever, children, cancer, leukemia, stem cell transplantation, infections in pediatric cancer patients presenting with fever during or following chemotherapy.
- Medical subject headings
- Infections, Fever, Neoplasms, Leukemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Dan Engelhard, MD, Principal investigator, Hadassah Medical OrganizationDiana Averbuch, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930267
- Sponsor's protocol ID
- yael12-HMO-CTIL
- Status last verified
- Jun 2009
- First submitted
- 28 Jun 2009
- Last updated
- 30 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Etiology of Infections in Pediatric Cancer Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT00930267
- Acronym / sponsor ID
- yael12-HMO-CTIL
- Conditions
- Infections
- Keywords
- fever, children, cancer, leukemia, stem cell transplantation, infections in pediatric cancer patients presenting with fever during or following chemotherapy.
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 30 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.
A prospective epidemiological study conducted in pediatric hematology oncology center in Hadassah medical center. The study will include all newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during chemotherapy.
In each event of febrile episode during chemotherapy, the following data will be collected using a patient data form and computerized software.
Demographic data: age, gender, ethnicity. Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.
Imaging data Microbiological data Outcome The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy
Key inclusion criteria (1 listed)
- Pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy
Key exclusion criteria (1 listed)
- No exclusions
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
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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.
Dan Engelhard, MD principal investigator
Hadassah Medical Organization
Diana Averbuch, MD principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by Hadassah Medical Organization.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Jun 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arik Tzukert, DMD (00 972 2 6776095, arik@hadassah.org.il), or a site near the patient. 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 30 Jun 2009.