InfectionsNCT00934115
Epidemiology of Infections in Pediatric Cancer Patients
An observational study of Infections, run by Rabin Medical Center.
Trial summary
Infections are common causes of morbidity and mortality in pediatric cancer patients. Today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Infections
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric cancer patients
Who may be able to join
- Pediatric cancer patients admitted to hospital with fever
Who cannot join
None listed.
About this study
Official title: Epidemiology of Infections in Pediatric Cancer Patients: A Prospective Multicenter Study in Israel
Infections are common causes of morbidity and mortality in pediatric cancer patients. Today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. Moreover, little data exist on the epidemiology of infections among pediatric patients with solid tumors.
The objectives of the present study are to define the incidence, categories of infections by organ systems, etiologic agents and risk factors for infections in different pediatric malignancies. The results of this study will help the investigators to better understand the epidemiology of infections in the different types of pediatric malignancies, enable the investigators to identify high risk patients, and design a better approach to empiric treatment of these patients.
Read more
A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center, Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly diagnosed with cancer and admitted to day care or inpatient departments with fever of >38.0 C will be included in the study. Demographic, clinical and microbiological figures will be collected in each center by a research assistant supervised by the infectious disease specialist. Data will be collected according to a pre-defined Patient Data Form and entered into an electronic data base that will be analyzed accordingly. In each event of febrile episode during chemotherapy, the following data will be collected by a research assistant 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.
- Conditions
- Infections
- Keywords
- To define the incidence, categories of infections by organ systems, etiologic agents and risk
- Medical subject headings
- Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJan 2008
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.
- 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
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934115
- Sponsor's protocol ID
- 0061-07-RMC
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 16 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Infections in Pediatric Cancer Patients: A Prospective Multicenter Study in Israel
- ClinicalTrials.gov ID
- NCT00934115
- Acronym / sponsor ID
- 0061-07-RMC
- Conditions
- Infections
- Keywords
- To define the incidence, categories of infections by organ systems, etiologic agents and risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- First posted
- 8 Jul 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.
Infections are common causes of morbidity and mortality in pediatric cancer patients. Today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. Moreover, little data exist on the epidemiology of infections among pediatric patients with solid tumors.
The objectives of the present study are to define the incidence, categories of infections by organ systems, etiologic agents and risk factors for infections in different pediatric malignancies. The results of this study will help the investigators to better understand the epidemiology of infections in the different types of pediatric malignancies, enable the investigators to identify high risk patients, and design a better approach to empiric treatment of these patients.
A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center, Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly diagnosed with cancer and admitted to day care or inpatient departments with fever of >38.0 C will be included in the study. Demographic, clinical and microbiological figures will be collected in each center by a research assistant supervised by the infectious disease specialist. Data will be collected according to a pre-defined Patient Data Form and entered into an electronic data base that will be analyzed accordingly. In each event of febrile episode during chemotherapy, the following data will be collected by a research assistant 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
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric cancer patients
Key inclusion criteria (1 listed)
- Pediatric cancer patients admitted to hospital with fever
Key exclusion criteria (0 listed)
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 16 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by Rabin Medical Center.
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 0 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 16 Jul 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?
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 16 Jul 2009.