Meropenem versus Cefotaxime as Empirical Treatment of Spontaneous Bacterial Peritonitis: Prospective, Randomized Clinical Trial

Hussein Kawashty Abdelrahman, Taha; Hussein El-Attar, Madiha Mohammed; Mohammed Ali, Adnan Ahmed

doi:10.21608/aeji.2025.340210.1433

Meropenem versus Cefotaxime as Empirical Treatment of Spontaneous Bacterial Peritonitis: Prospective, Randomized Clinical Trial

Afro-Egyptian Journal of Infectious and Endemic Diseases

Article 9, Volume 15, Issue 2, June 2025, Pages 184-192 PDF (453.73 K)

Document Type: Original Article

DOI: 10.21608/aeji.2025.340210.1433

Authors

Taha Hussein Kawashty Abdelrahman^* ; Madiha Mohammed Hussein El-Attar; Adnan Ahmed Mohammed Ali

Department of Tropical Medicine and Gastroenterology, Faculty of Medicine, Assiut University, Assiut, Egypt

Abstract

Background and study aim: recent studies have noticed that third-generation cephalosporin-resistant bacteria, that cause spontaneous bacterial peritonitis (SBP), are increasingly common. This work assessed the efficacy of meropenem versus cefotaxime as an empirical treatment of SBP.
Patients and Methods: A clinical randomized trial was conducted prospectively from January 2023 to January 2024. The enrolled 162 cirrhotic patients had pictures of SBP. Those patients were equally randomized into; group A patients were treated with intravenous meropenem one gram / eight hours and group B patients were treated with intravenous cefotaxime two gram/eight hours.
Results: Both groups had insignificant differences as regards baseline characteristics and comparable baseline Laboratory data. The most frequent isolated organisms were E. coli and Acinetobacter species followed by Klebsiella species and Pseudomonas species. The Meropenem group showed a significantly higher frequency of response to empirical therapy (71.4% vs. 55.8%) in comparison to the cefotaxime group. The estimated number of patients who needed to be treated with meropenem for one additional patient who would respond to empirical therapy was 6 cases to avoid failure of empirical therapy in patients with spontaneous bacterial peritonitis.
Conclusion: the current study stated that we could consider meropenem for empirical therapy for patients with spontaneous bacterial peritonitis with better response than third-generation cephalosporins. Perform such studies in multiple centers with a greater number of patients to draw firm conclusions about this issue.

Highlights

SBP treatment with third-generation cephalosporins (3rd GCs) has been increasing. The drug resistance rates of pathogens of community-acquired SBP (CASBP) and nosocomial SBP (NSBP) to 3rd GCs are high.
Meropenem empirical antibiotics are more effective in the treatment of SBP with a lower failure rate with higher response rate.

Keywords

Bacterial peritonitis; Meropenem; Cefotaxime

Full Text

INTRODUCTION

Spontaneous bacterial peritonitis (SBP) is the most common bacterial illness among cirrhotic patients. It is one of the most significant consequences of cirrhotic ascites, accounting for over 25% of all bacterial infections [1]. Nevertheless, over the last decade, there has been a reported shift in SBP microbial patterns, with an increase in the prevalence of gram-positive bacteria. Gram-positive bacteria have been found to account for almost half of culture-positive SBP. Another issue in SBP therapy is the rise of multidrug-resistant (MDR) bacteria, particularly in nosocomial infections [2] The current approach recommends third-generation cephalosporin (cefotaxime or ceftriaxone) or piperacillin-tazobactam as the first-line strategy for community-acquired spontaneous bacterial peritonitis; the latter is also to be considered for healthcare-associated and nosocomial spontaneous bacterial peritonitis in areas with low prevalence of infections by multidrug-resistant organisms [3].

Meropenem combined with glycopeptides or daptomycin has been suggested as the primary approach for healthcare-associated spontaneous bacterial peritonitis or in severe infections in areas with a high prevalence of multidrug-resistant organisms, and for nosocomial spontaneous bacterial peritonitis in general [3, 4]. Given the high rates of resistance, empirical cephalosporin treatment for noncommunity-acquired SBP is not indicated.

Previous studies supported piperacillin-tazobactam for empirical therapy of healthcare-related SBP and carbapenem-glycopeptide combo for nosocomial SBP [2]. It has been evidenced that every hour of inappropriate antibiotic use was associated with 1.9 higher odds of death in patients with cirrhosis and septic shock. Therefore, timely adequate antibiotic stewardship defined as the optimal selection, dosage, and duration of antimicrobial treatment saves lives [5].

Furthermore, it is known that one of the most common precipitants of hepatic encephalopathy is an acute infection with SBP [6]. Mortality from the first episode of SBP is 36% and 46% in culture-negative neutrocytic ascites (CNNA). After the sentinel episode of SBP, one-third of the patients can experience recurrent episodes of SBP within a year, and one-year mortality is approximately 32% [7].

This work was conducted to evaluate the efficacy of meropenem versus cefotaxime as an empirical treatment of spontaneous bacterial peritonitis.

METHODS

Study setting& design:

A single-center, prospective, randomized, clinical trial was conducted at Al-Rajhi University Hospital, Assiut University between January 2023 and January 2024.

The study was conducted according to the principles of the Declaration of Helsinki and was authorized by the Ethical Committee of the faculty of medicine, Assiut University, Assiut, Egypt (IRB no: 17101825/ 2022). The study was explained to all patients and only patients who were signing an informed consent participated in the study. This study was registered on clinicaltrials.gov with the identifier: NCT05427747.

Selection criteria:

All cirrhotic patients with ascites were diagnosed by ascitic fluid analysis as SBP (ascitic fluid polymorphonuclear cell (PMNC) count equal to or more than 250/mm³ [8]. Patients with ascites due to causes other than liver cirrhosis, HCC, and/or died within 48 hours after enrollment were excluded.

Sample size calculation and randomization:

Based on the previously reported in-hospital mortality rate that was 25.8% in the carbapenem group [9], the estimated minimum required total sample size is 112 participants with the following assumption; 5% alpha error, 80% power of the study, 95% confidence interval.

We enrolled a total of 162 patients with SBP during the period of the study. Out of them 8 patients died within 48 hours and were excluded. So, a total of 154 patients were recruited in the study and subdivided into two groups (figure 1).

Simple randomization was done with a ratio of 1:1. Each patient was randomly assigned to his group using the quick Calcs method for randomization either the meropenem group or the cefotaxime group.

Methodology

All patients were evaluated with history taking and clinical evaluation. Pelvic-abdominal ultrasonography examination was performed. Total leucocytic count, serum albumin, total bilirubin, serum urea, serum creatinine, and international normalized ratio were done. In addition to, the assessment of Child-Pugh and MELD scores.

The ascitic fluid analysis included measurement of protein and albumin, WBCs, and PMNL cell counts by automated counter.The ascitic fluid culture was done on blood broth (modified culture method and antibiotic sensitivity tests were done for all cases)

Treatment options that were given:

- Group A patients were treated with intravenous meropenem one gram / eight-hour

Group B patients were treated with intravenous cefotaxime two gram/eight hour.

After 48 hours of starting the antibiotics:

Ascitic fluid analysis was done, and the following interpretations were considered [10]:

- If PMNL in ascitic fluid decreased by 25% or more of the initial result. This indicates a good response to treatment, and we continued on the same antibiotic to complete 5 days of treatment.

- If PMNL in ascitic fluid decreased by less than 25% or increased more than the initial result, that indicates poor response, and we shifted to another antibiotic according to culture and sensitivity test in case of positive ascitic fluid culture for 5 days. Piperacillin-tazobactam ln case of negative ascitic fluid culture

The study outcome

The primary outcome was to determine the success rate of each antibiotic that was assessed by the percentage of reduction of ascitic fluid PMNL > 25% from the baseline count within 48 hours. The secondary outcome was determining theestimated number of patients who needed to be treated (number to treat; NTT) with meropenem for one additional patient would respond to empirical therapy.

Statistics

Recorded data were analyzed using the statistical package for social sciences, version 20.0 (SPSS Inc., Chicago, Illinois, USA). The Shapiro test was done at first to assess normality of the data. Quantitative data were expressed as mean ± Standard Deviation (SD) and compared with Student t test. Qualitative data were expressed as frequency and percentage and compared with Chi² test.

To calculate NTT, we determine at first; relative risk (RR) as follows; RR= (frequency of failure in meropenem group)/ (frequency of failure in cefotaxime group). Then the absolute risk reduction (ARR) was the difference between the frequency of failure in both groups. Then, NNT is the inverse of ARR. P value was significant if < 0.05.

RESULTS

Baseline characteristics data of studied groups (table 1):

The majority of patients were males and had normal BMI. The most frequent etiology of liver cirrhosis was HCV (83.1% vs. 76.6%) followed by HBV (11.7% vs. 14.3%). Both groups had comparable baseline data.

Clinical presentation and baseline laboratory data among the groups studied (table 2):

Both groups had insignificant differences as regards clinical presentation and baseline laboratory data. A total of 7 (9.09%) and 6 (7.79%) patients in the Meropenem and Cefotaxime groups were asymptomatic.

Results of ascitic fluid culture among the studied groups at the start of the study (table 3):

The most frequently isolated organisms were E. coli (44.2% v. 50.6%) and Acinetobacter species (9.1% vs. 2.6%) followed by Klebsiella species (5.2% vs. 2.6%) and Pseudomonas species (2.6% vs. 2.6%). Enterobacter aerogenes was isolated in only one patient. A total of 30 (39%) and 31 (40.3%) patients of meropenem and cefotaxime groups had no growth in the culture.

Ascitic fluid analysis after 48 hours of starting treatment to assess response (table 4):

The Meropenem group showed a significantly higher frequency of response to empirical therapy (71.4% vs. 55.8%; p= 0.03) in comparison to the cefotaxime group.

Number to treat in the current study:

Calculation of relative risk (RR)

RR to avoid failure of empirical treatment of SBP by usage of meropenem was calculated as follows, RR= (frequency of failure in meropenem group)/ (frequency of failure in cefotaxime group) = 28.6%/ 44.2%= 0.65 with 95% confidence interval (CI) was between 0.25 to 0.98. This means that patients who used meropenem for empirical treatment of SBP had a risk of failure of 0.65 lower than those who received cefotaxime.

Calculation of the number needed to treat (NNT)

Firstly, we calculated the absolute risk reduction (ARR) which is the difference between the frequency of failure in both groups 44.2%- 26.6% = 17.6%.

Secondly, NNT is the inverse of ARR= 1/0.176= 6 cases. So, this means that the estimated number of patients who needed to be treated with meropenem for one additional patient would respond to empirical therapy was 6 cases to avoid failure of empirical therapy in patients with SBP.

Table (1). Baseline characteristics of studied groups

	Meropenem G (n= 77)	Cefotaxime G (n= 77)	P value
Age (years)	64.06 ± 9.66	61.16 ± 15.47	0.16
Sex: Male	52 (67.5%)	53 (68.8%)	0.50
Female	25 (32.5%)	24 (31.2%)	0.50
Body mass index (kg/m²)	23.19 ± 1.65	24.21 ± 2.20	0.09
BMI: Underweight	5 (6.5%)	5 (6.5%)	0.70
Normal	40 (51.9%)	40 (51.9%)
Overweight	29 (37.7%)	31 (40.3%)
Obese	3 (3.9%)	1 (1.3%)
Occupation: Workers	29 (37.7%)	31 (40.3%)	0.56
Housewife	25 (32.5%)	24 (31.2%)
Employee	15 (19.4%)	14 (18.1%)
None	8 (10.4%)	8 (10.4%)
Diabetes mellitus	25 (32.5%)	27 (35.1%)	0.08
Hypertension	18 (23.4%)	14 (18.2%)	0.27
IHD	3 (3.9%)	1 (1.3%)	0.31
Smoking	31 (40.3%)	27 (35.1%)	0.30
LC causes: HCV	64 (83.1%)	59 (76.6%)	0.61
HBV	9 (11.7%)	11 (14.3%)
HCV/HBV	4 (5.2%)	6 (7.8%)
Autoimmune	0	1 (1.3%)

Data expressed as frequency (percentage), and mean (SD). P value was significant if < 0.05. BMI: body mass index; IHD: ischemic heart disease; LC: liver cirrhosis; HCV: hepatitis C virus; HBV: hepatitis B virus.

Table (2). Clinical presentation and baseline laboratory data among the studied groups

	Meropenem group (n= 77)	Cefotaxime group (n= 77)	P value
Presentation
Fever	30 (38.96%)	32 (41.56%)	0.70
Abdominal pain Abdominal Tenderness Increase of Ascites	42 (54.55%) 15 (19.48%) 20 (25.97%)	45 (58.44%) 17 (22.08%) 18 (23.38%)	0.57 0.68 0.68
Hepatic encephalopathy	33 (42.9%)	29 (37.7%)	0.48
Asymptomatic	7 (9.09%)	6 (7.79%)	0.70
Temperature (°C)	37.22 ± 0.73	37.14 ± 0.71	0.49
Leucocytes (10³/ul)	11.96 ± 1.76	10.24 ± 1.97	0.11
Creatinine (mmol/l)	147.91 ± 22.10	139.01 ± 13.87	0.44
Urea (mmol/l)	14.85 ± 2.65	13.51 ± 1.24	0.08
Bilirubin (umol/l)	46.89 ± 8.09	51.11 ± 9.56	0.79
INR	1.63 ± 0.45	1.56 ± 0.39	0.08
Albumin (mg/dl)	23.01 ± 2.98	22.21 ± 3.10	0.17
Degree of ascites by ultrasound			0.86
Mild	8 (10.4%)	7 (9.1%)
Moderate	47 (61%)	45 (58.4%)
Marked	22 (28.6%)	25 (32.5%)
Child score	10.35 ± 1.72	9.95 ± 1.75	0.15
Child class			0.50
Class B	25 (32.5%)	24 (31.2%)
Class C	52 (67.5%)	53 (68.8%)
MELD	16.73 ± 2.22	17.01 ± 1.90	0.91
Baseline ascitic fluid analysis
PMNL (cells/mm)	567.80 ± 60.11	570.11 ± 44.91	0.10
Albumin (g/dl)	1.02 ± 0.35	1.03 ± 0.40	0.69
Protein (g/dl)	1.36 ± 0.87	1.48 ± 0.91	0.42

Data expressed as mean (SD), and frequency (percentage). P value was significant if < 0.05. INR: international randomized ratio; MELD: model for end-stage liver disease; PMNL: polymorphonuclear leucocytes.

Table (3). Results of ascitic fluid culture among the studied groups

	Meropenem group (n= 77)	Cefotaxime group (n= 77)	P value
Ascitic fluid culture			0.44
No growth	30 (39%)	31 (40.3%)
E. coli	34 (44.2%)	39 (50.6%)
Acinetobacter species	7 (9.1%)	2 (2.6%)
Klebsiella species	4 (5.2%)	2 (2.6%)
Pseudomonas species	2 (2.6%)	2 (2.6%)
Enterobacter aerogenes	0	1 (1.3%)

Data expressed as frequency (percentage). P value was significant if < 0.05.

Table (4): Ascitic fluid analysis after 48 hours of starting treatment

	Meropenem group (n= 77)	Cefotaxime group (n= 77)	P value
Ascitic fluid analysis after 48 hours
PMNL (cells/mm³)	156.78 ± 55.67	340.11 ± 22.19	<0.001
Response to therapy*	55 (71.4%)	43 (55.8%)	0.03

Data expressed as mean (SD), and frequency (percentage). P value was significant if < 0.05. PMNL: polymorphonuclear leucocytes

*This was defined with > 25% reduction in PMNL in ascitic fluid after 48 hours

DISCUSSION

During the period of the current study, we identified a total of 154 cirrhotic patients with SBP from a total of 872 cirrhotic patients with ascites with SBP frequency was 17.66%. Those patients were randomly subdivided based on empirical antibiotics; either the meropenem group (n= 77 patients) or the cefotaxime group (n= 77 patients).

Both groups were comparable as regards demographic, clinical, laboratory data, and baseline ascitic fluid culture and analysis. In line with the current study, many previous studies stated that the frequency of SBP among patients with LC varies between 10-30% [11-13].

In the current study, we noticed that the majority of patients were males and the most frequent etiology of liver cirrhosis was HCV infection. Many previous studies had consistent findings with such results [12, 14-16].

Clinical presentation of SBP is highly variable and non-specific. A significant proportion of patients with SBP are even completely asymptomatic [17]. And hence diagnostic paracentesis to establish the diagnosis is recommended. Common symptoms reported to have some associations with SBP include fever, diarrhea, abdominal pain or tenderness, vomiting, etc [18].

One of the main findings in the current study; 13/154 (8.4%) patients were asymptomatic. Meanwhile, the most frequent presentation was fever and abdominal pain (tenderness). Other patients present with clinical deterioration in the form of hepatic encephalopathy and increasing ascites. In line with the current study; Cardranel et al (2013) found that 8.7% of patients were asymptomatic [11].

As regards the result of the ascitic fluid culture in the current study; it was found that 71/154 (46.1%) patients had no growth, and 83/154 (53.9%) patients had culture-positive SBP. Our results were similar to previous studies in which the commonest strain of gram-negative bacteria among patients infected with Gram-negative organisms was E. coli [16, 19-23].

The main and most important finding in the current study was that the meropenem group showed a significantly higher frequency of response to empirical therapy (71.4% vs. 55.8%; p= 0.03) in comparison to the cefotaxime group with a subsequent low failure rate of empirical therapy among meropenem group. Pimental et al (2021) concluded that 29.3% of patients showed resistance to TGC. This finding is probably related to the fact that MDR bacteria were more common in nosocomial SBP and consequently, the probability of treatment failure was expected to be high [24].

According to previous studies, resistance to the first-line antibiotic treatment significantly increased the 30-day mortality of SBP patients, underlining that knowledge of local antibiotic resistance patterns is crucial to SBP treatment success [2, 25, 26].

Lutz et al (2017) reported a lack of efficacy of carbapenems in 8% of the isolated microorganisms [27]. Guo et al (2019) did not report carbapenem resistance among gram-negative microorganisms. Resistance to carbapenems can be a life-threatening factor for the prognosis of SBP patients, with significantly lower 30-day survival probability [28].

Badawy et al (2013) concluded that empirical treatment with cefotaxime is effective in 81% of cases; meropenem is effective (100%) in cefotaxime-resistant cases [29]. Moreover, it was indicated that carbapenem-resistant gram-negative bacteria can be isolated from 0.2% to 0.3% of patients in tertiary hospitals. Moreover, particular consideration should be given to the stagnant development of antibiotics [28, 30].

The main limitation included a single-center study. Lack of blinding during randomization. No monitoring of adverse events. Also, we didn't assess the recurrence rate of SBP after discharge. The study is a randomized clinical trial, which is one of the most reliable forms of scientific evidence. It helps to minimize bias and ensure the comparability of groups.

CONCLUSION

Based on these findings, the use of meropenem as an empirical treatment for SBP appears to be more effective than cefotaxime, with a lower risk of treatment failure and a higher response rate, and could be used as an effective empirical antibiotic in patients with spontaneous bacterial peritonitis. Future multi-center studies are warranted to confirm such findings.

Ethical approval:

The study was conducted according to the principles of the Declaration of Helsinki and was approved by the Hospital’s Ethics Committee. The purpose of the study was explained to all participants, and written informed consent was obtained.

The study was approved by Assiut Faculty of Medicine, Institutional Review Board (IRB no: 17101825/ 2022). The study was explained to all patients and only patients who were signing an informed consent were participated in study. This study was registered on clinicaltrials.gov with identifier: NCT05427747.

Conflict of Interest: The authors declared that there were NO conflicts of Interest.

Funding Sources: None; declared

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Author Contributions: All authors make a substantial contribution to the article.

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