Randomised controlled trial of intravenous antibiotic treatment for ce
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《英国医生杂志》
1 Department of Public Health and General Practice, Christchurch School of Medicine and Health Sciences, PO Box 4345, Christchurch, New Zealand, 2 Pegasus Health PO Box 741, Christchurch, New Zealand, 3 Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand
Correspondence to P Corwin paul.corwin@chmeds.ac.nz
Abstract
Cellulitis, an acute bacterial infection of the skin and subcutaneous tissues, is a common condition that often requires treatment with intravenously administered antibiotics. This treatment is delivered in hospital in most countries, but intravenous treatment at home is used increasingly, particularly in the United States where insurance companies are reluctant to fund more expensive hospital treatment.1 Many retrospective reports exist on the outcomes of intravenous antibiotic treatment for cellulitis at home, which indicate that this is a safe alternative to inpatient treatment in hospital.2-6 Only one small prospective randomised trial has been reported that compared treatment at home with treatment in hospital, which included 37 patients with cellulitis.7 This study concluded that home treatment for conditions such as cellulitis and pneumonia was safe and associated with fewer adverse complications in elderly patients.
In the three years before this study, Christchurch Hospital admitted more than 500 patients each year for inpatient treatment of cellulitis. In the year before this study 1.7% of all adult medical admissions and 0.7% of surgical admissions were patients with the principal diagnosis of cellulitis. In 2001 Pegasus Health, an independent practitioners' association of 230 general practitioners in Christchurch, started a community care programme that delivered medical and nursing care to patients who would otherwise require hospital admission. The advent of this community care service initiated from general practice provided an ideal opportunity to mount a prospective, randomised trial with the objectives of comparing the safety, efficacy, and acceptability of home treatment with hospital treatment of cellulitis requiring intravenous antibiotics. Our hypothesis was that home treatment of cellulitis with intravenous antibiotics was as effective as hospital treatment and more acceptable to patients.
Methods
The trial ran from July 2002 until June 2003. We randomised 200 patients meeting the inclusion criteria to receive treatment either at home or in hospital. At the end of the trial we excluded six patients, three from each trial arm (owing to the randomisation process 101 patients were randomised initially to home treatment and 99 to hospital treatment) from the final analysis. Three of these patients had their diagnosis changed after trial entry to dermatitis, erythema nodosum, and a ruptured Baker's cyst. One patient was lost to follow up, one withdrew consent, and one home patient was allergic to cephazolin and had to be withdrawn from the trial as we did not have available an alternative intravenous antibiotic for home treatment at that time. Figure 1 shows the flow of participants through the trial.
Fig 1 Flow of participants through the trial
Table 1 shows the distribution of key variables between the two care groups. The two groups were similar except that the hospital care group were younger than the home care group (48 years v 55 years, respectively) and had a lower proportion of users of community service cards (37% v 53%). (Community service cards entitle holders to subsidised general practice, and they are issued on the basis of low income.) All patients treated at home received intravenous cephazolin. Fifty five per cent (53) of the hospital patients received cephazolin as well, but 29% (28) of the hospital patients received flucloxacillin and the remaining hospital patients various other antibiotics.
Table 1 Characteristics of patients at baseline. Values are percentages (numbers) of patients unless otherwise indicated
Clinical outcomes
The primary clinical outcome was days to no advancement of cellulitis. The mean was 1.50 (SD 0.11) days for the home treatment group and 1.49 (0.10) days for the hospital group (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). Because of the marked skew in all clinical outcomes we also compared the treatment arms by survival analysis, as shown in figure 2 and table 2. We found no significant differences on any of these outcomes, neither for simple comparisons of the two types of care nor when controlling for age, sex, location of cellulitis, and prior use of antibiotics.
Fig 2 Kaplan-Meier plots for primary and secondary outcomes
Table 2 Home care versus hospital care: hazard ratios with 95% confidence intervals
Patients' functional outcomes
We used independent t tests to analyse modified SF-36 questionnaires administered at baseline and at days 3 and 6 and found no significant differences in levels of physical functioning or pain between the two treatment arms (see appendix and table A on bmj.com))
Patients' satisfaction with site of treatment
Table 3 summarises the patients' level of satisfaction after one week of oral antibiotic treatment with the care they received as well as their theoretical preference for location of care. Most patients in both treatment arms were satisfied with the care they received. However, only one in 20 of the community arm would prefer hospital treatment, whereas one in three of those receiving hospital care felt that home care was preferable. These results strongly imply that home care is the preferred treatment choice of cellulitis patients, particularly those who have experienced community care.
Table 3 Patients' satisfaction with care after one week on oral antibiotics
Complications
Eleven patients (12%) randomised to home treatment required transfer to hospital. Four did not show satisfactory clinical improvement; one required surgical drainage under general anaesthetic; and two needed insertion of peripherally inserted central catheters. One patient was admitted because of an ischaemic toe, one because of a severe rash, one because of nausea and vomiting after starting oral antibiotics, and one because she was not coping at home.
Three hospital patients (3%) required readmission within one month of discharge for further treatment of their cellulitis. Two hospital patients received peripherally inserted central catheters while in hospital, and two patients required surgical drainage under general or spinal anaesthetic.
Discussion
Nathwani D, Tice A. Ambulatory antimicrobial use: the value of an outcomes registry. J. Antimicrob. Chemother 2002;49: 149-54.
Grayson ML, Silvers J, Turnidge J. Home intravenous antibiotic therapy. A safe and effective alternative to inpatient care. Med J Aust 1995;162: 249-53.
Leder K, Turnidge JD, Grayson ML. Home-based treatment of cellulitis with twice-daily cefazolin. Med J Aust 1998;169: 519-22.
Montalto M, Dunt D. Home and hospital intravenous therapy for two acute infections: an early study. Aust N Z J Med 1997;27: 19-23.
Tice AD. Experience with a physician-directed, clinic-based program for outpatient parenteral antibiotic therapy in the USA. Eur J Clin Microbiol Infect Dis 1995;14: 655-61.
Dall L, Peddicord T, Peterson S, Simmons T, Dall T. Hospitalist treatment of CAP and Cellulitis using objective criteria to select patients. Infect Med 2003;20: 379-90.
Caplan GA, Ward JA, Brennan NJ, Coconis J, Board N, Brown A. Hospital in the home: a randomised controlled trial. Med J Aust 1999;170: 156-60.
Eron LJ, Passos S. Early discharge of infected patients through appropriate antibiotic use. Arch Intern Med 2001;161: 61-5.
Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, et al. ACCP/SCCM Consensus Conference. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest 1992;101: 1644-55.
Australia/New Zealand Standard SF-36 Health Survey: Medical Outcomes Trust, 1994.
Grayson ML, McDonald M, Gibson K, Athan E, Munckhof WJ, Paull P, et al. Once-daily intravenous cefazolin plus oral probenecid is equivalent to once-daily intravenous ceftriaxone plus oral placebo for the treatment of moderate-to-severe cellulitis in adults. Clin Infect Dis 2002;34: 1440-8.
Outpatients Parenteral Antimicrobials Therapy. OPAT outcomes registry.www.opat.com/usregistry/ (accessed 29 Nov 2004).
Montalto M. Patients' and carers' satisfaction with hospital-in-the-home care. Int J Qual Health Care 1996;8: 243-51.
Dubois A, Santos-Eggimann B. Evaluation of patients' satisfaction with hospital-at-home care. Eval Health Prof 2001;24: 84-98.
Board N, Brennan NJ, Caplan GA. A randomised controlled trial of the costs of hospital as compared with hospital in the home for acute medical patients. Aust N Z J Public Health 2000;24: 305-11.
((Paul Corwin, senior lecturer1, Les Toop,)
Correspondence to P Corwin paul.corwin@chmeds.ac.nz
Abstract
Cellulitis, an acute bacterial infection of the skin and subcutaneous tissues, is a common condition that often requires treatment with intravenously administered antibiotics. This treatment is delivered in hospital in most countries, but intravenous treatment at home is used increasingly, particularly in the United States where insurance companies are reluctant to fund more expensive hospital treatment.1 Many retrospective reports exist on the outcomes of intravenous antibiotic treatment for cellulitis at home, which indicate that this is a safe alternative to inpatient treatment in hospital.2-6 Only one small prospective randomised trial has been reported that compared treatment at home with treatment in hospital, which included 37 patients with cellulitis.7 This study concluded that home treatment for conditions such as cellulitis and pneumonia was safe and associated with fewer adverse complications in elderly patients.
In the three years before this study, Christchurch Hospital admitted more than 500 patients each year for inpatient treatment of cellulitis. In the year before this study 1.7% of all adult medical admissions and 0.7% of surgical admissions were patients with the principal diagnosis of cellulitis. In 2001 Pegasus Health, an independent practitioners' association of 230 general practitioners in Christchurch, started a community care programme that delivered medical and nursing care to patients who would otherwise require hospital admission. The advent of this community care service initiated from general practice provided an ideal opportunity to mount a prospective, randomised trial with the objectives of comparing the safety, efficacy, and acceptability of home treatment with hospital treatment of cellulitis requiring intravenous antibiotics. Our hypothesis was that home treatment of cellulitis with intravenous antibiotics was as effective as hospital treatment and more acceptable to patients.
Methods
The trial ran from July 2002 until June 2003. We randomised 200 patients meeting the inclusion criteria to receive treatment either at home or in hospital. At the end of the trial we excluded six patients, three from each trial arm (owing to the randomisation process 101 patients were randomised initially to home treatment and 99 to hospital treatment) from the final analysis. Three of these patients had their diagnosis changed after trial entry to dermatitis, erythema nodosum, and a ruptured Baker's cyst. One patient was lost to follow up, one withdrew consent, and one home patient was allergic to cephazolin and had to be withdrawn from the trial as we did not have available an alternative intravenous antibiotic for home treatment at that time. Figure 1 shows the flow of participants through the trial.
Fig 1 Flow of participants through the trial
Table 1 shows the distribution of key variables between the two care groups. The two groups were similar except that the hospital care group were younger than the home care group (48 years v 55 years, respectively) and had a lower proportion of users of community service cards (37% v 53%). (Community service cards entitle holders to subsidised general practice, and they are issued on the basis of low income.) All patients treated at home received intravenous cephazolin. Fifty five per cent (53) of the hospital patients received cephazolin as well, but 29% (28) of the hospital patients received flucloxacillin and the remaining hospital patients various other antibiotics.
Table 1 Characteristics of patients at baseline. Values are percentages (numbers) of patients unless otherwise indicated
Clinical outcomes
The primary clinical outcome was days to no advancement of cellulitis. The mean was 1.50 (SD 0.11) days for the home treatment group and 1.49 (0.10) days for the hospital group (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). Because of the marked skew in all clinical outcomes we also compared the treatment arms by survival analysis, as shown in figure 2 and table 2. We found no significant differences on any of these outcomes, neither for simple comparisons of the two types of care nor when controlling for age, sex, location of cellulitis, and prior use of antibiotics.
Fig 2 Kaplan-Meier plots for primary and secondary outcomes
Table 2 Home care versus hospital care: hazard ratios with 95% confidence intervals
Patients' functional outcomes
We used independent t tests to analyse modified SF-36 questionnaires administered at baseline and at days 3 and 6 and found no significant differences in levels of physical functioning or pain between the two treatment arms (see appendix and table A on bmj.com))
Patients' satisfaction with site of treatment
Table 3 summarises the patients' level of satisfaction after one week of oral antibiotic treatment with the care they received as well as their theoretical preference for location of care. Most patients in both treatment arms were satisfied with the care they received. However, only one in 20 of the community arm would prefer hospital treatment, whereas one in three of those receiving hospital care felt that home care was preferable. These results strongly imply that home care is the preferred treatment choice of cellulitis patients, particularly those who have experienced community care.
Table 3 Patients' satisfaction with care after one week on oral antibiotics
Complications
Eleven patients (12%) randomised to home treatment required transfer to hospital. Four did not show satisfactory clinical improvement; one required surgical drainage under general anaesthetic; and two needed insertion of peripherally inserted central catheters. One patient was admitted because of an ischaemic toe, one because of a severe rash, one because of nausea and vomiting after starting oral antibiotics, and one because she was not coping at home.
Three hospital patients (3%) required readmission within one month of discharge for further treatment of their cellulitis. Two hospital patients received peripherally inserted central catheters while in hospital, and two patients required surgical drainage under general or spinal anaesthetic.
Discussion
Nathwani D, Tice A. Ambulatory antimicrobial use: the value of an outcomes registry. J. Antimicrob. Chemother 2002;49: 149-54.
Grayson ML, Silvers J, Turnidge J. Home intravenous antibiotic therapy. A safe and effective alternative to inpatient care. Med J Aust 1995;162: 249-53.
Leder K, Turnidge JD, Grayson ML. Home-based treatment of cellulitis with twice-daily cefazolin. Med J Aust 1998;169: 519-22.
Montalto M, Dunt D. Home and hospital intravenous therapy for two acute infections: an early study. Aust N Z J Med 1997;27: 19-23.
Tice AD. Experience with a physician-directed, clinic-based program for outpatient parenteral antibiotic therapy in the USA. Eur J Clin Microbiol Infect Dis 1995;14: 655-61.
Dall L, Peddicord T, Peterson S, Simmons T, Dall T. Hospitalist treatment of CAP and Cellulitis using objective criteria to select patients. Infect Med 2003;20: 379-90.
Caplan GA, Ward JA, Brennan NJ, Coconis J, Board N, Brown A. Hospital in the home: a randomised controlled trial. Med J Aust 1999;170: 156-60.
Eron LJ, Passos S. Early discharge of infected patients through appropriate antibiotic use. Arch Intern Med 2001;161: 61-5.
Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, et al. ACCP/SCCM Consensus Conference. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest 1992;101: 1644-55.
Australia/New Zealand Standard SF-36 Health Survey: Medical Outcomes Trust, 1994.
Grayson ML, McDonald M, Gibson K, Athan E, Munckhof WJ, Paull P, et al. Once-daily intravenous cefazolin plus oral probenecid is equivalent to once-daily intravenous ceftriaxone plus oral placebo for the treatment of moderate-to-severe cellulitis in adults. Clin Infect Dis 2002;34: 1440-8.
Outpatients Parenteral Antimicrobials Therapy. OPAT outcomes registry.www.opat.com/usregistry/ (accessed 29 Nov 2004).
Montalto M. Patients' and carers' satisfaction with hospital-in-the-home care. Int J Qual Health Care 1996;8: 243-51.
Dubois A, Santos-Eggimann B. Evaluation of patients' satisfaction with hospital-at-home care. Eval Health Prof 2001;24: 84-98.
Board N, Brennan NJ, Caplan GA. A randomised controlled trial of the costs of hospital as compared with hospital in the home for acute medical patients. Aust N Z J Public Health 2000;24: 305-11.
((Paul Corwin, senior lecturer1, Les Toop,)