Phase 3
N=66
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
Hodgkin Disease · Non-Hodgkin Lymphoma · Multiple Myeloma · Bacteremia
Bottom Line
View on ClinicalTrials.gov: NCT00398411 ↗Enrolled (actual)
66
Serious AEs
7.6%
Results posted
Dec 2013
Primary outcome: Primary: Incidence of Clinically Significant Bacteremia — 3; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- moxifloxacin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cologne
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Clinically Significant Bacteremia |
3; 9 | — |
| SECONDARY Type of Isolates and Infections |
0; 2; 1; 3; 0; 1 | — |
| SECONDARY Time to Occurrence of Fever >= 38°C |
9.50; 7.69 | — |
| SECONDARY Reason for Discontinuation of Treatment |
6; 0; 0; 0; 18; 23 | — |
| SECONDARY Type of Infection |
0; 1; 1; 1; 1; 0 | — |
| SECONDARY Overall Survival |
34; 31 | — |
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.
Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.
Eligibility Criteria
Inclusion Criteria
- High-dose chemotherapy followed by peripheral autologous stem cell transplantation
- Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid tumor
Exclusion Criteria
- Allogenic stem cell transplantation
- Aplastic anemia
- Antibiotic treatment within seven days prior to randomization
- Signs and symptoms of current infection
Data sourced from ClinicalTrials.gov (NCT00398411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.