Prospective Randomized Comparative Observations of Infectious Complications with or without Antimicrobial Prophylaxis, during Autologous Stem Cell Transplantation

Dong Hoe Koo; Ock Bae Ko; Shin Kim; Dae Ho Lee; Sang We Kim; Cheolwon Suh

doi:10.5045/kjh.2006.41.4.282

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Koo, Ko, Kim, Lee, Kim, and Suh: Prospective Randomized Comparative Observations of Infectious Complications with or without Antimicrobial Prophylaxis, during Autologous Stem Cell Transplantation

Original Article

Korean J Hematol 2006;41(4):282-288.

Published online: 19 January 2006

DOI: https://doi.org/10.5045/kjh.2006.41.4.282

Prospective Randomized Comparative Observations of Infectious Complications with or without Antimicrobial Prophylaxis, during Autologous Stem Cell Transplantation

Dong Hoe Koo, Ock Bae Ko, Shin Kim, Dae Ho Lee, Sang We Kim, Cheolwon Suh

Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Correspondence to：Cheolwon Suh Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine 388-1, Pungnap 2-dong, Songpa-gu, Seoul 138-736, Korea Tel: +82-2-3010-3209, Fax: +82-2-3010-6961 E-mail: csuh@amc.seoul.kr

Received 12 October 2006 Revised 27 October 2006 Accepted 2 November 2006

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background:

A prospective randomized comparative observation was performed to assess the benefit of prophylactic antimicrobials in autologous stem cell transplantation (ASCT).

Methods:

Forty consecutive patients, with multiple myelomas (MM, 28 patients) or a non-Hodgkin's lymphoma (NHL, 12 patients), were stratified by disease and randomly allocated to receive (prophylaxis group, 21 patients) or not receive (control group, 19 patients) prophylactic antimicrobials. The prophylactic antimicrobials consisted of ciprofloxacin (500mg twice daily p.o.), fluconazole (100mg twice daily p.o.) and acyclovir (400mg every 8 h p.o.), starting 1 day before high-dose chemotherapy (high-dose melphalan for MM and BEAM for NHL), and continuing until neutrophil engraftment or the occurrence of infection.

Results:

At least one episode of fever occurred in 15 of the 19 (79%) patients in the control group, compared with 12 of the 21 (57%) in the prophylaxis group (P=NS). Microbiologically or clinically documented infections occurred in 4 patients (21%) in the control group, but none occurred in the prophylaxis group (P=NS). The documented infections in the control group included 3 staphylococcal bacteremias and 1 herpes skin infection. No deaths, invasive fungal infections or serious adverse events occurred in either group. The median duration of fever (9 days in the control group and 11 days in the prophylaxis group), therapeutic antimicrobial therapy (9 days in the control group and 11 days in the prophylaxis group) and hospital stay after ASCT (19 days in both groups) did not differ between the groups.

Conclusion:

This small-sized prospective randomized comparative observation showed no beneficial effects of antimicrobial prophylaxis in ASCT.

Keywords: Autologous stem cell transplantation, Infectious complications, Antimicrobial prophylaxis

REFERENCES

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Table 1.

Patient characteristics

Characteristic	Prophylaxis grou (n=21)	p Control group (n=19)	p
Age (years)∗	54 (15~66)	51 (38~65)	NS
Gender
Male	12 (57%)	15 (79%)	NS
Female	9 (43%)	4 (21%)
Disease
Non-Hodgkin's lymphoma	6 (29%)	6 (32%)	NS
Multiple myeloma	15 (71%)	13 (68%)
Status of disease
1st CR	4 (19%)	2 (11%)	NS
≥2nd CR	3 (14%)	1 (5%)
Not in CR	14 (67%)	16 (84%)
CD34+ cell dose	8.78	9.59	NS
(×10⁶/kg)∗	(3.21~35.08)	(4.32~38.90)

∗Data are reported as median (range).

Abbreviation: NS, not significant; CR, complete remission.

Table 2.

Infectious complications and clinical courses

	Prophylaxis group (n=21)	Control group (n=19)	P
No. of febrile episodes during admission
0	9 (43%)	4 (21%)	NS
1	11 (52%)	13 (68%)
2	1 (5%)	2 (11%)
Onset of 1st febrile episode∗	Day+5 (day－4 to day+8)	Day+4 (day－8 to day+8)	NS
Duration of fever, days∗	11 (0~39)	9 (0~17)	NS
Days of antibiotics, days∗	11 (0~45)	9 (0~26)	NS
Classification of febrile episode
Fever only	12 (57%)	11 (58%)	NS
Clinically documented	0	1 (5%)
Microbiologically documented	0	3 (16%)
Median days to ANC ≥500/mm³	10 (95% CI: 9~11)	10 (95% CI: 10~10)	NS
Median days to PLT ≥20,000/mm³	12 (95% CI: 11~13)	11 (95% CI: 10~12)	NS
Duration of admission, days∗	19 (11~150)	19 (11~37)	NS

∗Data are reported as median (range).

Abbreviation: NS, not significant; ANC, absolute neutrophil count; PLT, platelet.

Table 3.

The 4 microbiologically or clinically documented infections in the control group

Pathogen	Infectious manifestation
Methicillin-sensitive	Bacteremia
Staphylococcus aureus
Methicillin-sensitive	Bacteremia
Staphylococcus epidermidis
Methicillin-resistant coagulase-negative	Bacteremia
Staphylococcus
Herpes simplex	Herpes labialis

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