NCT00398411 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2015-06-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Incidence of Clinically Significant Bacteremia

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outcome · POSTED

Type of Isolates and Infections

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outcome · POSTED

Time to Occurrence of Fever >= 38°C

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outcome · POSTED

Reason for Discontinuation of Treatment

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outcome · POSTED

Type of Infection

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
moxifloxacin 400 mg tablets once daily
intervention Names
Drug: moxifloxacin
label
Moxifloxacin
type
EXPERIMENTAL
description
identical appearing placebo
intervention Names
Drug: placebo
label
Placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Moxifloxacin
description
400 mg p.o. per day
name
moxifloxacin
other Names
Avalox
type
DRUG
arm Group Labels
Placebo
description
one tablet per day p.o.
name
placebo
other Names
placebo preparation
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR

primary Purpose

PREVENTION

Enrollment

count: 66
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
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)

secondary Outcomes

measure
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)
measure
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)
description
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
measure
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)
measure
Type of Infection
time Frame
follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
measure
Overall Survival
time Frame
follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)

Full study description

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.

Source references

references

citation
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.
pmid
22169408
type
RESULT

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice