MalignancyPhase 2/3NCT00215007
Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)
A Phase 2/3 study testing Levofloxacin in people with Malignancy and Allogeneic Stem Cell Transplantation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (SCT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignancy, Allogeneic Stem Cell Transplantation
- What is being tested?
- Levofloxacin
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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
Who may be able to join
- Allogeneic SCT
- Postneutropenic period
- Written consent
Who cannot join
- Fever
- Antibiotic therapy
- Neutropenia
- Refusal by the patient
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite, CBF
Berlin, State of Berlin, 12200
Igor Wolfgang Blau
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells
The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (SCT).
- Conditions
- Malignancy, Allogeneic Stem Cell Transplantation
- Being tested
- Levofloxacin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Igor Wolfgang Blau, Dr., Study chair, Charite, CBF, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215007
- Sponsor's protocol ID
- Levosta-CBF-02/04
- Status last verified
- Feb 2004
- First submitted
- 15 Sep 2005
- Last updated
- 30 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells
- ClinicalTrials.gov ID
- NCT00215007
- Acronym / sponsor ID
- Levosta-CBF-02/04
- Conditions
- Malignancy, Allogeneic Stem Cell Transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (SCT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Allogeneic SCT
- Postneutropenic period
- Written consent
Key exclusion criteria (4 listed)
- Fever
- Antibiotic therapy
- Neutropenia
- Refusal by the patient
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 |
|---|---|---|
| Levofloxacin | Drug | – |
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 Nov 2007.
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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.
Igor Wolfgang Blau, Dr. study chair
Charite, CBF, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levofloxacin in people with Malignancy and Allogeneic Stem Cell Transplantation, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 4 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 Nov 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Igor Wolfgang Blau, Dr. (0049 30 8445 4430, igor.blau@charite.de), 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 Nov 2007.