Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00398411

Acronym

MoxiProph

Enrollment

Registered

2006-11-10

Start date

2006-10-31

Completion date

2008-12-31

Last updated

2015-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Hodgkin Disease, Multiple Myeloma, Non-Hodgkin Lymphoma

Keywords

prophylaxis, bacteremia, moxifloxacin, stem cell transplantation, Hodgkin disease, non-Hodgkin lymphoma, multiple myeloma, solid tumor, autologous stem cell transplantation

Brief 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.

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.

Interventions

DRUGmoxifloxacin

400 mg p.o. per day

DRUGplacebo

one tablet per day p.o.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Clinically Significant Bacteremia	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.

Secondary

Measure	Time frame	Description
Type of Isolates and Infections	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	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	end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)	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
Type of Infection	follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)	—
Overall Survival	follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)	—

Countries

Germany

Participant flow

Recruitment details

First patient in: Oct 10, 2006; Last patient, last visit: Dec 08, 2008

Pre-assignment details

68 patients were intended for inclusion in the trial. Two patients were excluded due to violation of inclusion/exclusion criteria; both received no study drug and they were excluded from the analysis. The remaining 66 participants were evaluable for response analysis in the intention to treat (ITT) set.

Participants by arm

Arm	Count
Moxifloxacin moxifloxacin 400 mg tablets once daily	34
Placebo identical appearing placebo	32
Total	66

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	0	1

Baseline characteristics

Characteristic	Moxifloxacin	Placebo	Total
Age, Continuous	54 years	50 years	51.5 years
Height	172.71 cm STANDARD_DEVIATION 8.7	173.72 cm STANDARD_DEVIATION 9.7	173.2 cm STANDARD_DEVIATION 9.1
Sex: Female, Male Female	14 Participants	11 Participants	25 Participants
Sex: Female, Male Male	20 Participants	21 Participants	41 Participants
Status of Underlying Disease primary	20 participants	14 participants	34 participants
Status of Underlying Disease primary progressive	3 participants	3 participants	6 participants
Status of Underlying Disease relapsed	11 participants	15 participants	26 participants
Underlying Disease Hodgkin's Disease	4 participants	5 participants	9 participants
Underlying Disease Multiple Myeloma	16 participants	12 participants	28 participants
Underlying Disease NHL	14 participants	14 participants	28 participants
Underlying Disease Solid Tumor	0 participants	1 participants	1 participants
Weight	76.41 kg STANDARD_DEVIATION 13.9	75.00 kg STANDARD_DEVIATION 16.5	75.73 kg STANDARD_DEVIATION 15.1

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	34 / 34	32 / 32
serious Total, serious adverse events	2 / 34	3 / 32

Outcome results

Primary

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.

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)