Hodgkin DiseasePhase 3MoxiProphNCT00398411
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
A Phase 3 study testing moxifloxacin in people with Hodgkin Disease and Non-Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin Disease, Non-Hodgkin Lymphoma, Multiple Myeloma
- What is being tested?
- moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-dose chemotherapy followed by peripheral autologous stem cell transplantation
- Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid tumor
Who cannot join
- Allogenic stem cell transplantation
- Aplastic anemia
- Antibiotic treatment within seven days prior to randomization
- Signs and symptoms of current infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Mono-center, Placebo-controlled Pilot Study to Investigate the Efficacy and Safety of Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.
Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.
Read the detailed description
Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.
- Conditions
- Hodgkin Disease, Non-Hodgkin Lymphoma, Multiple Myeloma, Bacteremia
- Being tested
- moxifloxacin, placebo
- Keywords
- prophylaxis, bacteremia, moxifloxacin, stem cell transplantation, Hodgkin disease, non-Hodgkin lymphoma, multiple myeloma, solid tumor, autologous stem cell transplantation
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxifloxacinDrug
Also called Avalox
400 mg p.o. per day
placeboDrug
Also called placebo preparation
one tablet per day p.o.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Experimental | moxifloxacin 400 mg tablets once daily Receives: Drug: moxifloxacin |
| Placebo | Placebo comparator | identical appearing placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant Bacteremia
Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.
With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.
Measured: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Secondary outcomes (5)
Type of Isolates and Infections
Measured: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Time to Occurrence of Fever >= 38°C
Measured: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Reason for Discontinuation of Treatment
Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason
Measured: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Type of Infection
Measured: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
Overall Survival
Measured: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver A. Cornely, MD, Principal investigator, Universität zu Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398411
- Sponsor's protocol ID
- 05001
- Other IDs
- 2005-003271-21, 2005
- Acronym
- MoxiProph
- Status last verified
- Jun 2015
- First submitted
- 8 Nov 2006
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vehreschild JJ, Moritz G, Vehreschild MJ, Arenz D, Mahne M, Bredenfeld H, Chemnitz J, Klein F, Cremer B, Boll B, Kaul I, Wassmer G, Hallek M, Scheid C, Cornely OA. Efficacy and safety of moxifloxacin as antibacterial prophylaxis for patients receiving autologous haematopoietic stem cell transplantation: a randomised trial. Int J Antimicrob Agents. 2012 Feb;39(2):130-4. doi: 10.1016/j.ijantimicag.2011.10.009. Epub 2011 Dec 12.
PubMed 22169408
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Mono-center, Placebo-controlled Pilot Study to Investigate the Efficacy and Safety of Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
- ClinicalTrials.gov ID
- NCT00398411
- Acronym / sponsor ID
- MoxiProph / 05001
- Conditions
- Hodgkin Disease, Non-Hodgkin Lymphoma, Multiple Myeloma, Bacteremia
- Keywords
- prophylaxis, bacteremia, moxifloxacin, stem cell transplantation, Hodgkin disease, non-Hodgkin lymphoma, multiple myeloma, solid tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Nov 2006 (estimated)
- Results
- Posted 11 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.
Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.
Detailed description
Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Experimental | Drug: moxifloxacinmoxifloxacin 400 mg tablets once daily |
| Placebo | Placebo comparator | Drug: placeboidentical appearing placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High-dose chemotherapy followed by peripheral autologous stem cell transplantation
- Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid tumor
Key exclusion criteria (4 listed)
- Allogenic stem cell transplantation
- Aplastic anemia
- Antibiotic treatment within seven days prior to randomization
- Signs and symptoms of current infection
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 |
|---|---|---|
| moxifloxacinAlso: Avalox400 mg p.o. per day | Drug | Moxifloxacin |
| placeboAlso: placebo preparationone tablet per day p.o. | Drug | Placebo |
Primary outcome
Incidence of Clinically Significant Bacteremia
Time frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary. With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.
5 secondary outcomes
Type of Isolates and Infections
Time frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Time to Occurrence of Fever >= 38°C
Time frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Reason for Discontinuation of Treatment
Time frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Type of Infection
Time frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
Overall Survival
Time frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22169408Vehreschild JJ, Moritz G, Vehreschild MJ, Arenz D, Mahne M, Bredenfeld H, Chemnitz J, Klein F, Cremer B, Boll B, Kaul I, Wassmer G, Hallek M, Scheid C, Cornely OA. Efficacy and safety of moxifloxacin as antibacterial prophylaxis for patients receiving autologous haematopoietic stem cell transplantation: a randomised trial. Int J Antimicrob Agents. 2012 Feb;39(2):130-4. doi: 10.1016/j.ijantimicag.2011.10.009. Epub 2011 Dec 12.
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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.
Oliver A. Cornely, MD principal investigator
Universität zu Köln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing moxifloxacin in people with Hodgkin Disease and Non-Hodgkin Lymphoma, run by University of Cologne 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 2 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: finished, as of the sponsor's last update on 29 Jun 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 11 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Clinically Significant Bacteremia (time frame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398411, which also lists 1 linked publication.
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 29 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.