ThalassemiaNCT00456443
Invasive Infections in Children With Hemoglobinopathies
An observational study of Thalassemia and Sickle Cell Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause… Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Thalassemia, Sickle Cell Anemia
- What is being tested?
- Historical records
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Jun 2006
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients treated in the Pediatric Hematology Unit.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, 18101
About this study
Official title: Invasive Infections in Children With Hemoglobinopathies. A Clinical Descriptive Retrospective Study.
Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. The purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.
- Conditions
- Thalassemia, Sickle Cell Anemia
- Being tested
- Historical records
- Keywords
- Thalassemia, Sickle cell anemia, Splenectomy, Infections, Streptococcal Pneumonia
- Medical subject headings
- Thalassemia, Anemia, Sickle Cell, Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Historical recordsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startJan 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Koren, MD, Study director, Pediatric Hematology Unit, Ha'Emek Medical CenterWaheeb Sakran, MD, Principal investigator, Pediatric Dpt B - Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456443
- Sponsor's protocol ID
- 4140905.EMC
- Status last verified
- Apr 2007
- First submitted
- 4 Apr 2007
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Infections in Children With Hemoglobinopathies. A Clinical Descriptive Retrospective Study.
- ClinicalTrials.gov ID
- NCT00456443
- Acronym / sponsor ID
- 4140905.EMC
- Conditions
- Thalassemia, Sickle Cell Anemia
- Keywords
- Thalassemia, Sickle cell anemia, Splenectomy, Infections, Streptococcal Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 5 Apr 2007 (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.
Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. The purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients treated in the Pediatric Hematology Unit.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Historical records | Procedure or surgery | – |
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 5 Apr 2007.
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
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.
Ariel Koren, MD study director
Pediatric Hematology Unit, Ha'Emek Medical Center
Waheeb Sakran, MD principal investigator
Pediatric Dpt B - Ha'Emek Medical Center
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 Thalassemia and Sickle Cell Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
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: finished, as of the sponsor's last update on 5 Apr 2007. 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 Israel. 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 5 Apr 2007.