Oral vs Intravenous Antibiotics for Patients With Klebsiella pneumoniae Liver Abscess: A Randomized, Controlled
James S Molton1,2, Monica Chan3,4, Shirin Kalimuddin5,6
1Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.
Background:
Klebsiella pneumoniae liver abscess (KLA) is emerging worldwide due to hypermucoviscous strains with a propensity for metastatic infection. Treatment includes drainage and prolonged intravenous antibiotics. We aimed to determine whether oral antibiotics were noninferior to continued intravenous antibiotics for KLA.
Methods:
This noninferiority, parallel group, randomized, clinical trial recruited hospitalized adults with liver abscess and K. pneumoniae isolated from blood or abscess fluid who had received ≤7 days of effective antibiotics at 3 sites in Singapore. Patients were randomized 1:1 to oral (ciprofloxacin) or intravenous (ceftriaxone) antibiotics for 28 days. If day 28 clinical response criteria were not met, further oral antibiotics were prescribed until clinical response was met. The primary endpoint was clinical cure assessed at week 12 and included a composite of absence of fever in the preceding week, C-reactive protein <20 mg/L, and reduction in abscess size. A noninferiority margin of 12% was used.
Results:
Between November 2013 and October 2017, 152 patients (mean age, 58.7 years; 25.7% women) were recruited, following a median 5 days of effective intravenous antibiotics. A total of 106 (69.7%) underwent abscess drainage; 71/74 (95.9%) randomized to oral antibiotics met the primary endpoint compared with 72/78 (92.3%) randomized to intravenous antibiotics (risk difference, 3.6%; 2-sided 95% confidence interval, -4.9% to 12.8%). Effects were consistent in the per-protocol population. Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group.
Conclusions:
Oral antibiotics were noninferior to intravenous antibiotics for the early treatment of KLA.
Clinical Trials Registration:
NCT01723150.
Insights
Oral antibiotics are as effective as intravenous antibiotics for treating Klebsiella pneumoniae liver abscess (KLA). This finding supports using oral antibiotics for KLA, simplifying treatment for patients with this emerging infection.
Area of Science:
- Infectious Diseases
- Hepatology
- Clinical Trials
Background:
- Klebsiella pneumoniae liver abscess (KLA) is a growing global health concern.
- Hypermucoviscous strains of K. pneumoniae are associated with increased metastatic infections.
- Current KLA treatment involves drainage and prolonged intravenous antibiotics.
Purpose of the Study:
- To evaluate the noninferiority of oral antibiotics compared to intravenous antibiotics for KLA treatment.
- To assess clinical cure rates at 12 weeks in patients with KLA.
Main Methods:
- A randomized clinical trial involving 152 hospitalized adults with KLA.
- Patients received either oral (ciprofloxacin) or intravenous (ceftriaxone) antibiotics for 28 days.
- Clinical cure was defined by absence of fever, low C-reactive protein, and reduced abscess size.
Main Results:
- 95.9% of patients on oral antibiotics achieved clinical cure versus 92.3% on intravenous antibiotics.
- The risk difference was 3.6% (95% CI: -4.9% to 12.8%), meeting the noninferiority margin.
- Adverse event rates were similar between oral and intravenous antibiotic groups.
Conclusions:
- Oral antibiotics are noninferior to intravenous antibiotics for the early treatment of KLA.
- This suggests oral antibiotic therapy is a viable and effective option for KLA management.
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