A Randomized Study of Ciprofloxacin versus Ceftriaxone in the Treatment of Nursing Home‐Acquired Lower Respiratory Tract Infections

Hirata-Dulas, C. A. I.; Stein, Daniel J.; Guay, David R.P.; Gruninger, Robert P.; Peterson, Phillip K.

doi:10.1111/j.1532-5415.1991.tb04044.x

Cited by 66 publications

(39 citation statements)

References 34 publications

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“…Flaws of these studies have included lack of a double-blind design, exclusion of patients with underlying conditions associated with higher mortality, small sample sizes, and absence of intent-to-treat analyses (15-17, 27, 39-41, 43, 44). Other trials allowed inclusion of patients with a variety of lower respiratory tract infections and therefore did not enroll a clearly defined patient population (15,17,21,23,37,41,43,48,49). In the present study, we sought to avoid these criticisms and, accordingly, enrolled a relatively homogeneous population in which severity of illness measured by objective indices of respiratory dysfunction served as the entry criterion.…”

Section: 009)mentioning

confidence: 99%

“…Eighteen of the 43 deaths in the ciprofloxacin treatment group were attributed to the patients' underlying disease(s), 23 were attributed to bacterial infection, and 2 were considered indeterminate. In the imipenem treatment group, 21 deaths were attributed to an accompanying disease(s), 15 were attributed to bacterial infection, and 2 were considered indeterminate.…”

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confidence: 99%

“…In several recent reviews, mortality due to nosocomial pneumonia has been estimated to be 30 to 70% (6,11,12,26). However, most prospective antimicrobial clinical trials have been conducted in patient populations with mortality rates ranging from 4 to 33% (23,28,29,31). Severe cases of community-acquired pneumonia usually necessitate hospitalization and have been associated with a mortality rate as high as 21%, even among patients without obvious preexisting immune deficits (37,47).…”

Section: 009)mentioning

confidence: 99%

“…Previous trials often excluded critically ill patients, especially those requiring mechanical ventilation or with severe renal or hepatic dysfunction (16,17,43). Most previous trials have employed nonblind study designs (15,16,23,27,48,49), lacked an intent-to-treat analysis (16,27), suffered from small patient sample sizes (39)(40)(41)44), or enrolled patients with other infections in addition to pneumonia (21,23,27,48,49). This is the first large, randomized, double-blind comparative antimicrobial clinical trial utilizing a rigorous prospective study design with patients with severe pneumonia of which we are aware.…”

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confidence: 99%

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Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group

Fink

Snydman

Niederman

et al. 1994

Antimicrob Agents Chemother

446

240

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Intravenously administered ciprofloxacin was compared with imipenem for the treatment of severe pneumonia. In this prospective, randomized, double-blind, multicenter trial, which included an intent-to-treat analysis, a total of 405 patients with severe pneumonia were enrolled. The mean APACHE II score was 17.6, 79%o of the patients required mechanical ventilation, and 78% had nosocomial pneumonia. A subgroup of 205 patients (98 ciprofloxacin-treated patients and 107 imipenem-treated patients) were evaluable for the major efficacy endpoints. Patients were randomized to receive intravenous treatment with either ciprofloxacin (400 mg every 8 h) or imipenem (1,000 mg every 8 h), and doses were adjusted for renal function. The primary and secondary efficacy endpoints were bacteriological and clinical responses at 3 to 7 days after completion of therapy. Ciprofloxacin-treated patients had a higher bacteriological eradication rate than did imipenem-treated patients (69 versus 59%o; 95% confidence interval of -0.6%, 26.2%; P = 0.069) and also a significantly higher clinical response rate (69 versus 56%; 95% confidence interval of 3.5%, 28.5%; P = 0.021). The greatest difference between ciprofloxacin and imipenem was in eradication of members of the family Enterobateriaceae (93 versus 65%; P = 0.009). Stepwise logistic regression analysis demonstrated the following factors to be associated with bacteriological eradication: absence of Pseudomonas aeruginosa (P < 0.01), higher weight (P < 0.01), a low APACHE IH score (P = 0.03), and treatment with ciprofloxacin (P = 0.04). When P. aeruginosa was recovered from initial respiratory tract cultures, failure to achieve bacteriological eradication and development of resistance during therapy were common in both treatment groups (67 and 33% for ciprofloxacin and 59 and 53% for imipenem, respectively). Seizures were observed more frequently with imipenem than with ciprofloxacin (6 versus 1%; P = 0.028). These results demonstrate that in patients with severe pneumonia, monotherapy with ciprofloxacin is at least equivalent to monotherapy with imipenem in terms of bacteriological eradication and clinical response. For both treatment groups, the presence of P. aeruginosa had a negative impact on treatment success. Seizures were more common with imipenem than with ciprofloxacin. Monotherapy for severe pneumonia is a safe and elfective initial strategy but may need to be modified if P. aeruginosa is suspected or recovered from patients.Despite improvements in antimicrobial chemotherapy and supportive care, bacterial pneumonia, whether nosocomial or community acquired, remains an infection with substantial mortality. Nosocomial pneumonia accounts for about 15% of

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confidence: 99%

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confidence: 99%

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confidence: 99%

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confidence: 99%

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Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group

Fink

Snydman

Niederman

et al. 1994

Antimicrob Agents Chemother

446

240

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“…17 In a few small trials from the late 1980s or early 1990s, researchers found effectiveness of ceftriaxone or ciprofl oxacin to be equal when compared with similar antibiotics. [18][19][20][21] The ideal study design to test different regimens would be a randomized controlled trial; practical and ethical diffi culties make such a study unlikely. Consequently, we must rely on data from observational studies, attempting to control for differences between treatment groups.…”

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confidence: 99%

Antibiotic Treatment and Survival of Nursing Home Patients With Lower Respiratory Tract Infection: A Cross-National Analysis

Kruse

Mehr²,

Steen³

et al. 2005

The Annals of Family Medicine

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PURPOSE Although lower respiratory tract infections are a leading cause of death in frail elderly patients, few studies have compared treatments and outcomes. We assessed the effects of different antibiotic treatment strategies on survival of elderly nursing home residents with lower respiratory tract infections in the United States and the Netherlands, where treatment approaches are quite different. METHODSWe combined data from 2 prospective cohort studies of lower respiratory tract infections conducted in 36 nursing homes in the United States and 61 in the Netherlands. We included residents whose infections were treated with antibiotics: 806 in the United States and 415 in the Netherlands. Outcome measures were 1-month and 3-month mortality. We used logistic regression to adjust for differing illness severity.RESULTS Dutch residents had higher mortality than US residents (28.1% vs 15.1% at 1 month, respectively; P <.001). After adjusting for illness severity with logistic regression, the differences between the Dutch and US populations were not significant (odds ratio 1.34; 95% confi dence interval, 0.94-1.90). Predicted mortality was overestimated for more severely ill US residents at 1 month but not at 3 months. No antibiotic regimen was consistently associated with increased or decreased mortality. CONCLUSION Despite differences in illness severity and treatment, adjusted mortality did not differ between the 2 countries. Although we cannot exclude a short-term survival benefi t from more aggressive treatment in the United States, differences in baseline health appear prognostically more important than the type of antibiotic treatment.

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Empirical Atypical Coverage for Inpatients With Community-Acquired Pneumonia

Shefet¹,

Robenshtok²,

Leibovici³

2005

Arch Intern Med

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A Randomized Study of Ciprofloxacin versus Ceftriaxone in the Treatment of Nursing Home‐Acquired Lower Respiratory Tract Infections

Cited by 66 publications

References 34 publications

Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group

Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group

Antibiotic Treatment and Survival of Nursing Home Patients With Lower Respiratory Tract Infection: A Cross-National Analysis

Empirical Atypical Coverage for Inpatients With Community-Acquired Pneumonia

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