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PubMed1997

Results of a randomized, multicenter trial of meropenem versus clindamycin/tobramycin for the treatment of intra-abdominal infections.

In a randomized, double-blind clinical trial conducted at 13 medical centers, meropenem (1,000 mg given iv every 8 hours) was compared with the combination of clindamycin (900 mg every 8 hours) plus tobramycin (5 mg/[kg.d] in three divided doses) given iv for the treatment of intra-abdominal infections that required surgery and parenteral antibiotic therapy. At the end of treatment, efficacy data on patients who met study inclusion criteria (intent-to-treat) were available for 132 of 215 patients in the meropenem group and 134 of 212 patients in the clindamycin/tobramycin group; 120 (91%) of 132 intent-to-treat patients in the meropenem group were cured, 115 (86%) of 134 intent-to-treat patients in the clindamycin/tobramycin group were cured (P value, not significant). Of the patients treated with meropenem and considered evaluable according to the study protocol, 89 (92%) of 97 were cured, and 81 (86%) of 94 patients treated with clindamycin/tobramycin and considered evaluable were cured. Bacteriologic response rates for all evaluable patients (n = 191) were 96% (93 of 97 patients) among those randomized to the meropenem arm and 93% (87 of 94) among those randomized to the clindamycin/tobramycin arm. Adverse events occurred with similar frequency in both treatment groups; neither seizures nor deaths related to treatment were reported for any patients in either group. The results of this trial demonstrated that meropenem, together with appropriate surgical intervention, was safe and effective in the treatment of patients who had bacterial intra-abdominal infections, most of which were secondary to complicated appendicitis.

Abdominal Abscess↗

PubMed1997

Pharmacokinetics of meropenem in animals, healthy volunteers, and patients.

Meropenem is a carbapenem antibiotic that appears to be widely distributed in tissues and is eliminated by both excretion and metabolism. Approximately 70% of meropenem is excreted via the kidneys, thus dosage adjustments are required for patients with renal impairment. The pharmacokinetic parameters for meropenem are similar to those for imipenem/cilastatin, with the exception of meropenem's smaller volume of distribution. The urinary recovery of meropenem is as high as that of imipenem in combination with cilastatin, an inhibitor of renal dehydropeptidase. Therefore, unlike imipenem, meropenem can be used without dehydropeptidase inhibitors to obtain a consistently high concentration in the urine without nephrotoxic effects.

Adult↗

PubMed1989

Antibacterial properties of meropenem towards clinical isolates, beta-lactamase producers and laboratory mutants.

Clinical isolates (1017) obtained from a multicentre study were examined. The activity of meropenem was better than that of imipenem against Enterobacteriaceae and Pseudomonas aeruginosa. Meropenem was slightly less active against staphylococci than was imipenem. Meropenem had little activity against enterococci (MIC90, 16 mg/l). Mutants selected with imipenem or meropenem remained more sensitive to meropenem but MICs increased for both drugs. Other resistance mechanisms such as beta-lactamases or aminoglycoside modifying enzymes did not influence meropenem activity with the exception of beta-lactamase from Ps. cepacia.

Bacteria↗

PubMed1989

The postantibiotic effect of meropenem and imipenem on selected bacteria.

Controlled experiments were conducted to determine the in-vitro postantibiotic effect (PAE) of meropenem and imipenem on ten selected bacteria representative of medically important species: Staphylococcus aureus (2). Pseudomonas aeruginosa (4), Escherichia coli (1), Serratia marcescens (1), Morganella morganii (1), and Providencia stuartii (1). The PAE was determined by comparing serial colony counts of cultures recovering from exposure to drug concentrations at 4 x MIC for 1.5 h with the counts of drug-free controls. A PAE was observed with both meropenem and imipenem when tested against four strains of Ps. aeruginosa (meropenem PAE = 0.8-2 h; imipenem PAE = 1.2-2.5 h) and two strains of Staph. aureus (meropenem PAE = 0.7, 1.7 h; imipenem PAE = 1.7, 1.8 h). In addition, a PAE was observed with meropenem on two of four Enterobacteriaceae, E. coli ATCC 25922 (0.8 h) and Prov. stuartii (1.2 h), but not with one strain each of M. morganii and Ser. marcescens. A PAE was not observed when imipenem was tested against the four Enterobacteriaceae. Studies are suggested to investigate further the PAE of meropenem on additional strains of Enterobacteriaceae.

Bacteria↗

PubMed1989

Comparative in-vitro activity of meropenem on clinical isolates from the United Kingdom.

MICs of meropenem were determined for a wide range of common bacteria of clinical importance. For Enterobacteriaceae, Aeromonas spp., Haemophilus influenzae, Branhamella catarrhalis, Neisseria gonorrhoeae, Gardnerella vaginalis, Campylobacter coli/jejuni, beta-haemolytic streptococci and anaerobes other than Clostridium difficile, MICs were almost always within the range 0.002-0.5 mg/l. The activity of meropenem for these organisms was always greater than that of imipenem and piperacillin, and was similar to that of ceftazidime and cefotaxime except that strains resistant to these latter, and to piperacillin, were usually sensitive to imipenem and meropenem. Meropenem was also active against most non-fermentative Gram-negative bacilli, with MICs in the range 0.12-4 mg/l but Pseudomonas (Xanthomonas) maltophilia was often resistant, as it was to all the other drugs tested. Staphylococci, Strreptococcus pneumoniae and other alpha-haemolytic streptococci were usually more sensitive to imipenem than to meropenem, but even methicillin-resistant staphylococci were sensitive to both drugs (MICs less than 4 mg/l). Enterococci were also less sensitive to meropenem than to imipenem, and Enterococcus faecium was invariably highly resistant to all the drugs tested except ciprofloxacin, which had marginal activity. Results for Ps. maltophilia and Haem. influenzae were affected by media used for sensitivity testing.

Bacteria↗

PubMed1989

In-vitro activity of meropenem against clinical isolates obtained in Canada.

The in-vitro activity of meropenem, a new parenteral carbapenem, was compared with that of imipenem, ceftazidime, cefotaxime, piperacillin, gentamicin and, where appropriate, other antibiotics against recent clinical isolates and characterized beta-lactamase producers. MICs were determined by a standard agar dilution procedure and two inocula (10(4) and 10(6) cfu) were used throughout. Meropenem inhibited 90% of isolates of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, indole-positive Proteus spp., Enterobacter spp., Serratia marcescens and Providencia stuartii at less than or equal to 0.25 mg/l and was four- to 16-fold more active than imipenem against these species. Against the enteric pathogens Salmonella typhi, Shigella sonnei, Yersinia enterocolitica and Campylobacter jejuni, meropenem was four- to eight-fold more active than imipenem, inhibiting all isolates at less than or equal to 0.03 mg/l. Meropenem was also more active than imipenem against Haemophilus influenzae (MIC90 0.06 mg/l) but had similar activity against the Bacteroides fragilis group (MIC90 0.25 mg/l), against Pseudomonas aeruginosa (MIC90 2 mg/l) and against streptococci. Imipenem was four-fold more active than meropenem against Acinetobacter spp. and two- to eight-fold more active against all species of staphylococci tested. Both meropenem and imipenem were inactive against Ps. (Xanthomonas) maltophilia.

Bacteria↗

PubMed1995

Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease in hospitalised patients--a comparison of meropenem and imipenem/cilastatin. COPD Study Group.

Meropenem and imipenem/cilastatin were compared in an open, randomised prospective multicentre study in the treatment of acute exacerbations of severe chronic obstructive pulmonary disease in hospitalised patients. One-hundred-and-seventy-three patients were enrolled; 164 were evaluable for clinical efficacy and 98 for bacteriological efficacy, with 144 pathogens isolated. The predominant pathogens were Haemophilus influenzae (n = 30), Streptococcus pneumoniae (18), Staphylococcus aureus (12), Pseudomonas aeruginosa (11), Moraxella catarrhalis (8), other Gram-negative bacteria (Neisseria, Klebsiella, Proteus, and Enterobacter spp.) (53) and other Gram-positive bacteria (12). A single bacterial pathogen was identified in 61 patients, whereas two bacterial pathogens were isolated in 31 patients and three in six patients. The clinical response at the end of treatment was very high in both groups with a satisfactory outcome (cured or improved) in 97.6% of the meropenem patients and in 96.3% of the imipenem/cilastatin patients; at follow-up the rates were 89.1% and 89.8%, respectively. The bacterial success (eradication or presumed eradication) was 88.2% in the meropenem group and 89.4% in the comparator group. Nausea or vomiting were reported more frequently in patients treated with imipenem/cilastatin, whereas in the meropenem group an increase in aminotransferases was reported. One patient treated with imipenem/cilastatin was withdrawn from the study due to seizures. Meropenem and imipenem/cilastatin were highly effective for the treatment of severe bacterial exacerbations of chronic bronchitis but meropenem was better tolerated.

Bacterial Infections↗

PubMed1995

Antibiotic monotherapy with meropenem in the surgical management of intra-abdominal infections.

In an open, multicentre, randomised study, the efficacy and safety of meropenem monotherapy as adjuvant antibiotic therapy in the surgical management of intra-abdominal infection was compared with that of the combination of cefotaxime and metronidazole. A total of 160 hospitalised adult patients with intra-abdominal infection requiring surgery were treated intravenously with either meropenem 1 g every 8 h (by bolus injection or infusion; n = 77) or cefotaxime 2 g and metronidazole 500 mg every 8 h (n = 83). Clinical and bacteriological responses to antibiotic therapy were assessed at the end of treatment and at 2-4 weeks' follow-up after treatment. The clinical response rates at the end of treatment and follow-up were 91% and 96%, respectively, for meropenem and 100% and 97%, respectively, for cefotaxime plus metronidazole. The bacteriological response rates were 90% and 93%, respectively, for meropenem and 92% at both time points for cefotaxime plus metronidazole. Both treatments were well tolerated. In this study, meropenem monotherapy was effective and as well tolerated as cefotaxime plus metronidazole. Meropenem monotherapy should, therefore, prove a useful alternative to standard combination therapy for the empirical treatment of intra-abdominal infections.

Abdomen↗

PubMed1999

Continuous infusion versus intermittent administration of meropenem in critically ill patients.

This prospective crossover study compared the pharmacokinetics of meropenem by continuous infusion and by intermittent administration in critically ill patients. Fifteen patients were randomized to receive meropenem either as a 2 g iv loading dose, followed by a 3 g continuous infusion (CI) over 24 h, or by intermittent administration (IA) of 2 g iv every 8 h (q8h). Each regimen was followed for a period of 2 days, succeeded by crossover to the alternative regimen for the same period. Pharmacokinetic parameters (mean +/- SD) of CI included the following: concentration at steady state (Css) was 11.9+/-5.0 mg/L; area under the curve (AUC) was 117.5+/-12.9 mg/L x h. The maximum and minimum serum concentrations of meropenem (Cmax, Cmin) and total meropenem clearance (CItot) for IA were 110.1+/-6.9 mg/L, 8.5+/-1.0 mg/L and 9.4+/-1.2 L/h, respectively. The AUC during the IA regimen was larger than the AUC during CI (P < 0.001). In both treatment groups, meropenem serum concentrations remained above the MICs for the most common bacterial pathogens. We conclude that CI of meropenem is equivalent to the IA regimen and is therefore suitable for treating critically ill patients. Further studies are necessary to compare the clinical effects of CI and IA in this patient group.

Adolescent↗

PubMed2000

Elimination of meropenem during continuous veno-venous haemofiltration and haemodiafiltration in patients with acute renal failure.

Meropenem elimination was studied in six patients with acute renal failure on continuous venovenous haemofiltration (CVVH) or continuous veno-venous haemodiafiltration (CVVHDF) 1 L/h and 2 L/h for 12 h. Meropenem 1 g was given iv over three dialysis periods, and plasma, ultrafiltrate/dialysate and urine concentrations of meropenem were determined. The half-life of meropenem was significantly longer (P < 0.05) during CVVH (7.5 +/- 2.0 h; mean +/- S.D.) than during CVVHDF 1 L/h (5.6 +/- 1.4 h) or 2 L/h (4.8 +/- 1.2 h). Meropenem clearance was 3.27 +/- 2.30 L/h, 4.72 +/- 2.69 L/h and 5.71 +/- 3.58 L/h in CVVH, CVVHDF 1 L/h and CVVHDF 2 L/h, respectively (P < 0.05 between CVVH and CVVHDF). Patients with renal failure on CVVHDF 1 or 2 L/h should be treated with meropenem 1 g bid; 500 mg tid may be enough for patients on CVVH.

Acute Kidney Injury↗

PubMed2001

Meropenem versus ceftazidime as empirical monotherapy in febrile neutropenia of paediatric patients with cancer.

This trial assessed the efficacy and safety of meropenem versus ceftazidime as empirical monotherapy for febrile neutropenia in paediatric cancer patients. In a prospective randomized study, 172 evaluable febrile episodes in the meropenem arm and 170 episodes in the ceftazidime arm were analysed for the clinical and microbiological response dependent on the kind of infection. About half the episodes were classified as fever of unknown origin (FUO) and the remainder as microbiologically or clinically documented infections. The most frequently documented infections in both arms were bacteraemias (22.1 versus 26.5%), predominantly caused by Gram-positive organisms (57.9 versus 71.1%). The success rate of the initial monotherapy differed significantly between the two arms and was 55.8% in the meropenem and 40.0% in the ceftazidime arm (P = 0.003). In addition, a significantly longer duration of fever and of antimicrobial therapy was observed in the ceftazidime arm than in the meropenem arm (median 5 versus 4 days, P = 0.022, and 7 versus 6 days, P = 0.009, respectively). With respect to the kind of infection, differences between the two arms were significant only in episodes classified as FUO but not in documented infections. In both arms, side effects were minimal. Despite the greater response rate for meropenem in FUO, the fact that ceftazidime has been proven to be as effective as meropenem in documented infections in the present study suggests that both drugs are useful as empirical monotherapy in febrile paediatric cancer patients.

Bacterial Infections↗

PubMed2005

Spread of efflux pump-overexpressing, non-metallo-beta-lactamase-producing, meropenem-resistant but ceftazidime-susceptible Pseudomonas aeruginosa in a region with blaVIM endemicity.

OBJECTIVES: To investigate the resistance mechanisms of meropenem-resistant, ceftazidime-susceptible Pseudomonas aeruginosa isolates, in a clinical setting where VIM-2 or VIM-4 metallo-beta-lactamase (MBL)-producing pseudomonads are common. METHODS: During May to December 2003, 13 consecutive meropenem-resistant, ceftazidime-susceptible P. aeruginosa isolates were recovered from separate patients at the University Hospital of Larissa, Thessaly, Greece. The isolates were studied by Etest MBL, PCR for blaVIM, blaIMP and blaSPM genes and PFGE. Experiments were performed to detect synergy between meropenem or other antimicrobials and the efflux pump inhibitor carbonyl cyanide-m-chlorophenylhydrazone (CCCP). The isolates were also tested by PCR and RT-PCR for the expression of the genes mexB and mexY, which encode the efflux pumps MexAB-OprM and MexXY-OprM. RESULTS: Twelve of the isolates, belonging to six distinct PFGE types, gave negative results in the MBL Etest and lacked genes encoding MBLs but exhibited synergy between meropenem and CCCP, indicating that efflux pump activity contributed to the meropenem resistance. All 12 isolates were positive for mexB and 11 were also positive for mexY genes. RT-PCR showed that 10 and five isolates over-expressed mexB and mexY, respectively. One isolate was blaVIM-2-positive and did not show synergy with CCCP, or harbour mexB or mexY. CONCLUSIONS: In our hospital, where MBL-producing P. aeruginosa were previously prevalent, meropenem resistance due to the overexpression of efflux pumps has also now emerged. Early recognition of this resistance mechanism should allow the use of alternative beta-lactams, such as ceftazidime, which would be inactive even against phenotypically susceptible MBL producers.

Bacterial Outer Membrane Proteins↗

PubMed2000

Pharmacokinetics and dosing regimen of meropenem in critically ill patients receiving continuous venovenous hemofiltration.

OBJECTIVE: To study the pharmacokinetics of meropenem in critically ill patients with acute renal failure receiving continuous venovenous hemofiltration (CWHF). DESIGN: Prospective, open-labeled study. SETTING: Medical intensive care unit of the University Medical Center Utrecht. PATIENTS: Five critically ill patients receiving CWHF for acute renal failure treated with meropenem for documented or suspected bacterial infection. INTERVENTION: All patients received meropenem (500 mg) administered intravenously every 12 hrs. Plasma samples and ultrafiltrate aliquots were collected during one dosing interval. MEASUREMENTS AND RESULTS: Mean age and body weight of the patients studied were 46.6 yrs (range, 28-61 yrs) and 85.8 kg (range, 70-100 kg), respectively. The following pharmacokinetic variables for meropenem were obtained: mean peak plasma concentration was 24.5 +/- 7.2 mg/L, mean trough plasma concentration was 3.0 +/- 0.9 mg/L, mean terminal elimination half-life was 6.37 +/- 1.96 hrs, mean total plasma clearance was 4.57 +/- 0.89 L/hr, mean CWHF clearance was 1.03 +/- 0.42 L/hr, mean nonrenal clearance was 3.54 +/- 1.06 L/hr, and mean volume of distribution was 0.37 +/- 0.15 L/kg. CONCLUSION: In critically ill patients with acute renal failure, nonrenal clearance became the main elimination route. CWHF substantially contributed to the clearance of meropenem (23% of mean total plasma clearance). We recommend meropenem to be dosed at 500 mg intravenously every 12 hrs in patients receiving CWHF, according to our operational characteristics. This dosing regimen resulted in adequate trough plasma levels for susceptible microorganisms.

Acute Kidney Injury↗

PubMed1993

Pharmacokinetics of meropenem in experimentally burned rats.

The pharmacokinetics of meropenem were investigated to examine its penetration into the skin of third degree burned rats. The rats were divided into two groups. One group acted as the control, and the other group had third degree burns induced by immersing their backs into 80 degrees C water for 20 seconds. The rats in each group were given 20 mg/kg of body weight of meropenem intravenously by one bolus injection seven days after burn inducement or depilation. In the non-burned control group, the maximum concentrations of meropenem in the serum and skin of 6.03 micrograms/ml and 0.12 microgram/g were respectively obtained 15 minutes after the injection and decreased very rapidly thereafter. In the burned rats, the maximum concentrations of meropenem in the serum, skin (eschar), and exudate fluid of 7.07 micrograms/ml, 1.44 micrograms/g and 5.99 micrograms/ml were respectively obtained 15 minutes after the injection and decreased very slowly. The penetration of meropenem into the burned skin was higher than that into the normal skin. These results suggest that meropenem is a very useful antibiotic in the treatment of burn infection.

Animals↗

PubMed1992

Pharmacokinetics of meropenem and its metabolite in young and elderly healthy men.

The pharmacokinetics of meropenem and its ring-opened metabolite (ICI 213,689) were investigated with eight young (20- to 34-year-old) and eight elderly (67- to 80-year-old) healthy male volunteers given single 30-min intravenous infusions of 500 mg of meropenem. All subjects had normal age-correlated glomerular function. The mean terminal half-life of meropenem was 1.27 h in the elderly subjects versus 0.81 h in the younger subjects (P less than 0.001). This and similar increases in mean residence time and area under the concentration-time curve were explained by a reduction in total [139 versus 203 ml/(min.1.73 m2); P less than 0.001], renal, and nonrenal clearances in subjects at advanced ages. The apparent volume of distribution and urinary recovery over 8 h were not significantly altered. With the metabolite, prolonged serum half-life and mean residence time, enlarged area under the concentration-time curve, and lower renal clearance but no significant changes in peak plasma concentration or urinary recovery were found in the elderly. The reduction in the renal excretion rate of meropenem and its metabolite corresponds to the age-associated physiological decline in renal function. The capacity to metabolize meropenem may also be slightly impaired in people at advanced ages. Dose reduction of meropenem should be considered for elderly patients.

Adult↗

PubMed1992

Pharmacokinetics of meropenem in subjects with various degrees of renal impairment.

Five healthy volunteers and 18 patients with various degrees of renal impairment received 500 mg of meropenem intravenously as a 30-min infusion. Five dialysis patients were dosed 2 h prior to hemodialysis, and four of them were also dosed between hemodialysis treatments. Plasma and urine samples were collected for up to 48 h and 12 h, respectively. Concentrations of meropenem and its open ring metabolite ICI 213,689 were determined by high-performance liquid chromatography and radioimmunoassay, respectively. The subjects were divided into four groups with glomerular filtration rates (GFR) of greater than 80, 30 to 80, 5 to 29, or less than 5 ml/min. There were linear correlations between the GFR and the rates for total plasma clearance as well as renal clearance of meropenem (group mean values for total clearance of 186, 74, 53, and 19 ml/min/1.73 m2, respectively). In subjects with normal renal function, nonrenal clearance accounted for approximately 20% of total elimination, increasing to about 50% in patients with GFR between 5 and 29 ml/min/1.73 m2. The terminal half-life of meropenem increased from 0.9 h in the healthy volunteers to 6.8 h in patients with end-stage renal disease. The half-life of ICI 213,689 was 2.31 h in the healthy volunteers and increased to 23.6 h in patients with GFR of 5 to 29 ml/min. In patients with end-stage renal disease, half-lives could not be measured, as concentrations were hardly declining during the 48-h observation period. The area under the concentration-time curve for meropenem increased more than 10-fold. Both meropenem and its open ring metabolite were readily dialyzable, with dialysis clearances of 79 and 81 ml/min/1.73 m2, respectively.

Adult↗

PubMed1995

Relative importances of outer membrane permeability and group 1 beta-lactamase as determinants of meropenem and imipenem activities against Enterobacter cloacae.

The roles of outer membrane permeability and Bush group 1 beta-lactamase activity in determining Enterobacter cloacae susceptibility to either meropenem or imipenem were investigated. A beta-lactamase-deficient strain was obtained by mutagenesis from a clinical isolate of E. cloacae, and a porin-deficient strain was selected from this mutant with cefoxitin. Both strains were transformed with the plasmid pAA20R, which contained the gene coding for the carbapenem-hydrolyzing CphA beta-lactamase, and the carbapenem permeability coefficients were measured by the Zimmermann and Rosselet technique (W. Zimmermann and A. Rosselet, Antimicrob. Agents Chemother. 12:368-372, 1977). The permeability coefficient of meropenem was roughly half that of imipenem in the normally permeable strain and almost seven times lower than that of imipenem in the porin-deficient strain. In the porin-deficient strain, the virtual absence of porins caused the MICs of meropenem to increase from 8 to 16 times, while it did not affect the MICs of imipenem. Conversely, the beta-lactamase affected imipenem but not meropenem activity: meropenem showed a similar activity in the parent strain and in the beta-lactamase-deficient mutant with both a low- and high-density inoculum, whereas imipenem was 16 times less active against the parent strain when the high-density inoculum was used. It is concluded that outer membrane permeability and stability to group 1 beta-lactamase have different impacts on the activities of meropenem and imipenem against E. cloacae.

Bacterial Proteins↗

PubMed1995

In vitro activity and killing effect of DX-8739, a new carbapenem, compared with those of meropenem and imipenem against multiresistant Pseudomonas aeruginosa.

DX-8739 is a new dehydropeptidase I-stable carbapenem. In order to evaluate its activity in comparison with those of meropenem and imipenem, 147 multiresistant Pseudomonas aeruginosa isolates acquired nosocomially were simultaneously exposed to the actions of the three carbapenems in vitro, whereas to compare their killing effects on 14 strains, 56 killing curve studies were performed. Overall DX-8739 was found to possess inhibitory activity as well as bactericidal activity statistically superior to those of meropenem and imipenem. At a concentration of 4 micrograms/ml, 106 strains (72.1%) were found to be imipenem resistant; 33 and 27.4% of these strains were inhibited by DX-8739 and meropenem, respectively, a statistically significant difference (P < 0.05). DX-8739 was also shown to possess intrinsic activity in vitro superior to those of meropenem and imipenem against the imipenem-susceptible population of strains. However, no statistically significant difference regarding the comparative killing activities of the three studied carbapenems was observed. Following exposure to carbapenem for 24 h, 33.3, 44.4, and 70% of the strains which survived became resistant to DX-8739, meropenem, and imipenem, respectively. The reported results demonstrate the significant activity of DX-8739 against multiresistant P. aeruginosa strains acquired nosocomially. The mechanism of action of DX-8739 on P. aeruginosa is unknown, and various hypotheses that might explain its in vitro superiority over meropenem and imipenem are proposed.

Anti-Bacterial Agents↗