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PubMed1997

A multi-centre study to compare meropenem and cefotaxime and metronidazole in the treatment of hospitalized patients with serious infections.

We conducted a prospective, multi-centre, open, randomized study in 11 UK hospitals to compare iv meropenem 1 g tds with the combination of iv cefotaxime 1 g tds and iv metronidazole 500 mg tds in patients with serious infections. One hundred and sixty-one patients were enrolled, of whom 131 were clinically evaluable (meropenem, n = 68; cefotaxime/metronidazole, n = 63). The most common infections were subsequent to intra-abdominal pathology (meropenem, n = 77%; cefotaxime/metronidazole, n = 75%), and were usually accompanied by septicaemia (meropenem, n = 61%; cefotaxime/metronidazole, n = 53%). The incidence of a satisfactory clinical response was similar in the two groups at the end of treatment (93% for meropenem; 92% for cefotaxime/metronidazole) and up to 8 weeks later (96% for meropenem; 93% for cefotaxime/metronidazole). Satisfactory bacteriological response (success or presumed success) was recorded at the end of therapy in 86% of meropenem and 88% of cefotaxime/metronidazole patients. Adverse events were reported in 32% of meropenem and 25% of cefotaxime/metronidazole patients, and most were mild or moderate and did not require discontinuation of therapy. Twenty-one patients (ten meropenem and 11 cefotaxime/metronidazole) died during the trial, underlining the severity of the infections being treated in this group of patients. None of the deaths was thought to be related to study therapy.

Adult↗
PubMed2003

Comparison of the pharmacodynamics of meropenem in healthy volunteers following administration by intermittent infusion or bolus injection.

OBJECTIVES: The aim of this study was to compare the pharmacokinetics and pharmacodynamics of meropenem when administered by 3 h infusion or bolus injection regimens. PATIENTS AND METHODS: The study was a randomized three-way crossover study with a 1 week wash-out period in 12 healthy volunteers. Each subject received a single dose of meropenem in three regimens: (i) bolus injection of 1 g meropenem; (ii) 3 h infusion of 1 g meropenem; and (iii) 3 h infusion of 0.5 g meropenem. RESULTS: Following bolus injection of 1 g meropenem, the mean +/- s.d. percentages of the t > MIC of 4, 2 and 1 mg/L were 42.50 +/- 6.20%, 54.38 +/- 7.64% and 67.04 +/- 8.47% of an 8 h dosing interval, respectively. For the 3 h infusion of 1 g meropenem, the percentages of the t > MIC of 4, 2 and 1 mg/L were 59.27 +/- 7.34%, 71.97 +/- 8.63% and 86.07 +/- 9.41% of an 8 h dosing interval, respectively. For the 3 h infusion of 0.5 g meropenem, the percentages of the t > MIC of 4, 2 and 1 mg/L were 47.27 +/- 5.34%, 59.36 +/- 6.60% and 71.44 +/- 8.45% of an 8 h dosing interval, respectively. CONCLUSIONS: We conclude that a 3 h infusion of 0.5 g or 1 g of meropenem both give greater values for t > MIC than a 1 g bolus and that intermittent infusion may be a useful mode of administration in tropical countries where drug instability may prevent the use of continuous infusion.

Adolescent↗
PubMed2004

Plasma pharmacokinetics and urine concentrations of meropenem in ewes.

The pharmacokinetics of meropenem was studied in five ewes after single i.v. and i.m. dose of 20 mg/kg bw. Meropenem concentrations in plasma and urine were determined using microbiological assay method. A two-compartment open model was best described the decrease of meropenem concentration in plasma after an i.v. injection. The drug was rapidly eliminated with a half-life of elimination (t1/2beta) of 0.39 +/- 0.30 h. Meropenem showed a small steady-state volume of distribution [Vd(ss)] 0.055 +/- 0.09 L/kg. Following i.m. injection, meropenem was rapidly absorbed with a t1/2ab of 0.25 +/- 0.04 h. The peak plasma concentration (Cmax) was 48.79 +/- 8.83 microg/mL was attained after 0.57 +/- 0.13 h (tmax). The elimination half-life (t1/2el) of meropenem was 0.71 +/- 0.12 h and the mean residence time (MRT) was 1.38 +/- 0.26 h. The systemic bioavailability (F) after i.m. injection was 112.67 +/- 10.13%. In vitro protein-binding percentage of meropenem in ewe's plasma was 42.80%. The mean urinary recoveries of meropenem over 24 h were 83% and 91% of the administered dose after i.v. and i.m. injections respectively. Thus, meropenem is likely to be efficacious in the eradication of many urinary tract pathogens in sheep.

Animals↗
PubMed2003

Comparison of plasma and interstitial fluid concentrations of doxycycline and meropenem following constant rate intravenous infusion in dogs.

OBJECTIVE: To compare plasma (total and unbound) and interstitial fluid (ISF) concentrations of doxycycline and meropenem in dogs following constant rate IV infusion of each drug. ANIMAL: 6 adult Beagles. PROCEDURE: Dogs were given a loading dose of doxycycline and meropenem followed by a constant rate IV infusion of each drug to maintain an 8-hour steady state concentration. Interstitial fluid was collected with an ultrafiltration device. Plasma and ISF were analyzed by high performance liquid chromatography. Protein binding and lipophilicity were determined. Plasma data were analyzed by use of compartmental methods. RESULTS: Compared with meropenem, doxycycline had higher protein binding (11.87% [previously published value] vs 91.75 +/- 0.63%) and lipophilicity (partition coefficients, 0.02 +/- 0.01 vs 0.68 +/- 0.05). A significant difference was found between ISF and plasma total doxycycline concentrations. No significant difference was found between ISF and plasma unbound doxycycline concentrations. Concentrations of meropenem in ISF and plasma (total and unbound) were similar. Plasma half-life, volume of distribution, and clearance were 4.56 +/- 0.57 hours, 0.65 +/- 0.82 L/kg, and 1.66 +/- 2.21 mL/min/kg, respectively, for doxycycline and 0.73 +/- 0.07 hours, 0.34 +/- 0.06 L/kg, and 5.65 +/- 2.76 mL/min/kg, respectively, for meropenem. The ISF half-life of doxycycline and meropenem was 4.94 +/- 0.67 and 2.31 +/- 0.36 hours, respectively. CONCLUSIONS AND CLINICAL RELEVANCE: The extent of protein binding determines distribution of doxycycline and meropenem into ISF. As a result of high protein binding, ISF doxycycline concentrations are lower than plasma total doxycycline concentrations. Concentrations of meropenem in ISF can be predicted from plasma total meropenem concentrations.

Animals↗
PubMed2000

Meropenem versus imipenem/cilastatin in the treatment of sepsis in Chinese patients.

BACKGROUND: Meropenem and imipenem are beta-lactam antibiotics of the carbapenem group. Carbapenems have bactericidal activity against a broad spectrum of bacteria, including most gram-positive cocci, gram-negative bacilli and anaerobes. Experience in using meropenem in Chinese patients has not been previously reported. METHODS: Meropenem (2 g daily) and imipenem/cilastatin (2 g daily) were compared in an open, randomized, prospective study on the treatment of hospitalized Chinese septic patients. All participants (male or female) were hospitalized with a diagnosis of sepsis. All patients were randomly allocated to one of the two treatment groups: the meropenem group or the imipenem/cilastatin group. Clinical status was evaluated daily during treatment and at the end of therapy or when treatment was withdrawn. Patients were checked every day for potential side-effects, according to subjective and objective symptoms. RESULTS: Fifty-three patients were enrolled in the study; 50 were evaluated for clinical efficacy and 27 patients were evaluated for bacteriologic efficacy. The most frequent clinical diagnoses were pneumonia and urinary tract infection. The predominant pathogens were Pseudomonas aeruginosa, Escherichia coli and Enterobacter cloacae. There were 31 pathogens isolated from 27 patients. A single pathogen was identified in 23 patients, and two pathogens were isolated from four patients. Satisfactory clinical outcome (excellent and good) was 84% in the meropenem group and 76% in the imipenem/cilastatin group. Satisfactory bacteriologic response was 80% in the meropenem group and 75% in the imipenem/cilastatin group. Transiently elevated liver enzymes were the most common side-effect. One patient treated with imipenem/cilastatin experienced a seizure during the study, while another patient treated with meropenem withdrew due to urticaria. CONCLUSIONS: The efficacy and safety data presented in this report indicate that meropenem was well tolerated and appeared to be as effective as standard monotherapy with imipenem in bacteremic patients. Meropenem and imipenem/cilastatin were highly effective for the treatment of bacteremia in Chinese patients and only mild or negligible side-effects were noted.

Adult↗
PubMed1992

In vitro and in vivo antibacterial activities of meropenem, a new carbapenem antibiotic.

The in vitro and in vivo antibacterial activities of meropenem were compared with those of imipenem, ceftazidime, flomoxef, cefuzonam and cefotiam. Meropenem showed a broad antibacterial spectrum against clinical isolates of Gram-positive and Gram-negative bacteria. Against Gram-negative bacteria, with the exception of Acinetobacter calcoaceticus, meropenem exhibited the most potent activity among the drugs tested. It inhibited all 330 strains of Enterobacteriaceae at 0.78 mg/l. Meropenem was sensitive against several cephem-resistant strains of Enterobacteriaceae. Against Pseudomonas aeruginosa, meropenem was four-fold more active than imipenem and eight-fold more active than ceftazidime, with an MIC90 of 0.78 mg/l. The therapeutic effect of meropenem on systemic infection in mice was ten to twenty-fold less than that of imipenem against Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae. However, meropenem was as effective as imipenem on infections of Escherichia coli, Klebsiella pneumoniae, Serratia marcescens, Acinetobacter calcoaceticus and Pseudomonas aeruginosa. Meropenem was eliminated from mice plasma two-fold faster than imipenem, with a plasma half-life of 7.6 min. From the above results the authors concluded that meropenem is a promising drug for clinical use.

Animals↗
PubMed1998

[Comparative study of meropenem and amikacin/metronidazole combination in the treatment of severe abdominal surgical infections].

The authors compared in a prospective, randomized study the efficacy of amikacin/metronidazole combination and meropenem monotherapy in serious, intra-abdominal infections needing surgical treatment. There were 31 evaluable patients. Fifteen patients were involved to the meropenem and 16 to the combination group. The average age were 46 years in the meropenem group and 50 in the other one, the APACHE II score was similar (12.9 and 12.5). Among the examined parameters, only the white blood cell number decrease showed significant difference between the study groups. In the meropenem group 5.05 x 10(9), while in the comparator group 3.57 x 10(9) (p < 0.01). At the end of the study period, the infection was cured in the case of 11 patients in the meropenem and 9 patients in the control-group. At the end of the treatment the average APACHE II score decreased to 7.6 and to 9.6 points respectively. Clinically both therapies proved to be effective and well tolerated but the microbiological assessment revealed that meropenem tended to cover all pathogens of the mostly polymicrobial infections (12 cases, 43%) more frequently, than amikacin/metronidazole combination (9 cases, 33%). The Gram negative bacteria showed sensitivity to both meropenem and amikacin, but their majority were inhibited by meropenem at a concentration 1 or 2 orders of magnitude lower, than by amikacin. The therapeutic dose of meropenem is not toxic; therefore, it can be safely administered in poor general condition, frequently with renal impairment. We did not observed serious adverse event during the study period.

Abdomen↗
PubMed1998

[Multicenter open randomized trial of meropenem in comparison to ceftazidime and amikacin used in combination in severe hospital infections].

Clinical efficacy and tolerance of meropenem were estimated by comparison with those of ceftazidime and amikacin used in combination in the therapy of hospital infections of the lower respiratory tract, skin and soft tissues, intraabdominal and gynecologic infections, urinary tract infection and sepsis. 48 patients were given meropenem in a dose of 1 g every 8 hours for 3-14 days (the average of 9 days). 47 patients were subjected to the routine combined therapy: ceftazidime in a dose of 1 g every 8 hours and amikacin in a dose of 0.5 g every 12 hours for 2-14 days (the average of 9 days). The patient groups were comparable by the age, nature and severity of the infection and the condition (the mean APACHE II of 9.1 and 8.9). By the end of the treatment a positive clinical effect (recovery and improvement) was observed in 47 patients (97.9 per cent) treated with meropenem and in 41 patients (89.1 per cent) subjected to the combined therapy. The infection relapse within 4 weeks after the treatment completion was recorded in 3 patients in every group. Before the treatment 133 microbial strains were isolated from the patients. 121 of them were susceptible to meropenem (91.1 per cent), 111 to amikacin (83.4 per cent) and 90 to ceftazidime (67.7 per cent). The difference between meropenem and ceftazidime was significant (p = 0.0005). Eradication of the primary pathogens at the background of the meropenem therapy was stated in 41 out of 44 patients (93.2 per cent) and that of the combined therapy in 38 out of 43 patients (88.4 per cent). The microbiological relapse after the treatment completion was recorded in 3 and 2 patients, respectively. Side effects were observed in 8.3 per cent of the patients treated with meropenem and in 10.6 per cent of the patients subjected to the combined therapy. The trial results were indicative of the meropenem high efficacy and good tolerance and of the possible use of the drug in the monotherapy as an alternative of the routine combined therapy of severe hospital infections.

Adolescent↗
PubMed1997

Prospective, randomised, multicentre study of meropenem versus imipenem/cilastatin as empiric monotherapy in severe nosocomial infections.

The clinical and bacteriological efficacy and the tolerability of meropenem versus imipenem/cilastatin (both 1 g t.i.d.) in severe nosocomial infections were compared in a multicentre, randomised, nonblinded study. A total of 151 patients were recruited; 133 (66 meropenem, 67 imipenem/cilastatin) were clinically evaluable and 84 (42 meropenem, 42 imipenem/cilastatin) bacteriologically evaluable. Most clinically evaluable patients (90%) were in intensive care units, required mechanical ventilation (72%), and had received previous antibiotic therapy (62%). The mean (+/- SD) APACHE II score was 15.2 (+/- 6.6) in the meropenem group and 17.8 (+/- 6.8) in the imipenem/cilastatin group. The primary infections were nosocomial lower respiratory tract infections (56% of patients), intra-abdominal infections (15%), septicaemia (21%), skin/skin structure infections (5%), and complicated urinary tract infections (3%); 35% of the patients had two or more infections. There was no significant difference between the meropenem and imipenem/cilastatin groups in the rates of satisfactory clinical (weighted percentage 87% vs. 74%) or bacteriological (weighted percentage 79% vs. 71%) response. There was a slightly higher rate of clinical success with meropenem against primary or secondary lower respiratory tract infection (89% vs. 76%). Drug-related adverse events occurred in 17% and 15% of meropenem and imipenem/cilastatin patients, respectively. Meropenem (1 g t.i.d.) was as efficacious as the same dose of imipenem/cilastatin in this setting, and both drugs were well tolerated.

Adolescent↗
PubMedDate not supplied

Empirical monotherapy with meropenem versus imipenem/cilastatin for febrile episodes in neutropenic patients.

In a nonblind, randomised, parallel-group study, initial empirical monotherapy with meropenem 1 g intravenously every 8 h was compared to an identical dosage of imipenem/cilastatin for the treatment of 66 febrile episodes in 61 adult neutropenic patients. 25/31 episodes treated with meropenem and 24/30 imipenem/cilastatin-treated episodes were still receiving unmodified therapy at 72 h (primary endpoint); this difference was not statistically significant. By the end of the treatment courses, 18/31 meropenem-treated episodes had responded clinically (cured or improved) compared with 18/30 episodes treated with imipenem/cilastatin. Another ten episodes initially treated with meropenem and six episodes treated with imipenem/cilastatia were cured after an additional antimicrobial agent had been administered (cured with modification). Satisfactory bacteriological responses (eradication plus presumed eradication) at the end of unmodified therapy was 9/11 in the meropenem group and 14/16 in the comparator group. Both regimes were well tolerated; however, there were more reports of nausea and/or vomiting in the impenem/cilastatin group (7/33 vs. 2/33 in the meropenem group). The carbapenems meropenem and imipenem/cilastatin appear to be suitable agents for empirical monotherapy of febrile episodes in neutropenic patients. Meropenem may be better tolerated than imipenem/cilastatin, allowing optimal dosing in this patient population.

Adult↗
PubMed2003

Meropenem prevents levofloxacin-induced resistance in penicillin-resistant pneumococci and acts synergistically with levofloxacin in experimental meningitis.

The aim of the present study was to investigate the potential synergy between meropenem and levofloxacin in vitro and in experimental meningitis and to determine the effect of meropenem on levofloxacin-induced resistance in vitro. Meropenem increased the efficacy of levofloxacin against the penicillin-resistant pneumococcal strain KR4 in time-killing assays in vitro and acted synergistically against a second penicillin-resistant strain WB4. In the checkerboard, only an additive effect (FIC indices: 1.0) was observed for both strains. In cycling experiments in vitro, levofloxacin alone led to a 64-fold increase in the MIC for both strains after 12 cycles. Addition of meropenem in sub-MIC concentrations (0.25 x MIC) completely inhibited the selection of levofloxacin-resistant mutants in WB4 after 12 cycles. In KR4, the addition of meropenem led to just a twofold increase in the MIC for levofloxacin after 12 cycles. Mutations detected in the genes encoding for topoisomerase IV (parC) and gyrase (gyrA) confirmed the levofloxacin-induced resistance in both strains. Addition of meropenem was able to completely suppress levofloxacin-induced mutations in WB4 and led to only one mutation in parE in KR4. In experimental meningitis, meropenem, given in two doses (2 x 125 mg/kg), produced a good bactericidal activity (-0.45 Deltalog10 cfu/ml.h) comparable to one dose (1 x 10 mg/kg) of levofloxacin (-0.44 Deltalog10 cfu/ml.h) against the penicillin-resistant strain WB4. Meropenem combined with levofloxacin acted synergistically (-0.93 Deltalog10 cfu/ml.h), sterilizing the CSF of all rabbits.

Animals↗
PubMed1999

Meropenem pharmacokinetics in a patient with multiorgan failure from Meningococcemia undergoing continuous venovenous hemodiafiltration.

Meropenem is a carbapenem antibiotic with a broad antibacterial spectrum of activity. Its main route of elimination is through the kidneys, with 63% of the drug excreted unchanged in the urine. Meropenem clearance is diminished in renal impairment; therefore, doses need to be adjusted in patients with varying degrees of renal function. An appropriate dose of meropenem for patients undergoing continuous venovenous hemodiafiltration (CVVHDF) is unknown. We evaluated the pharmacokinetics of meropenem in a patient with fulminant meningococcemia undergoing CVVHDF. Meropenem concentrations in serial venous, arterial, and ultrafiltrate samples after a 1 g intravenous dose were measured using high-performance liquid chromatography (HPLC). Meropenem clearance was found to be 129.36 mL/min and 141.29 mL/min for every 8- and 12-hour dosing, respectively. Trough levels were above the MIC90 for Neisseria meningitidis and most anaerobic pathogens. We recommend that meropenem 1 g intravenously every 12 hours be used as the initial dose in patients undergoing CVVHDF. Differences between meropenem clearance during CVVHDF and other forms of renal replacement therapy are discussed.

Adult↗
PubMed1997

Comparative in vitro activity of meropenem versus other extended-spectrum antimicrobials against randomly chosen and selected resistant clinical isolates tested in 26 North American centers.

The in vitro antibacterial activity of meropenem and up to nine other antimicrobials was compared in studies at 26 North American centers from 1989 to 1992 with use of standardized and controlled procedures for determining minimal inhibitory concentrations (MICs) against 12,483 recent clinical isolates and additional drug-resistant strains. Overall, carbapenems were the most active drugs. The antibacterial activity of meropenem was consistent against random isolates in all centers; however, inclusion of large proportions of multidrug-resistant gram-negative aerobes by some centers did increase MICs of meropenem and the comparators. Meropenem was 4-64 times more active than imipenem against gram-negatives, including Enterobacteriaceae organisms, Pseudomonas aeruginosa, Burkholderia cepacia, Neisseria meningiditis, and Haemophilus influenzae. Imipenem was up to 2-4 times more active than meropenem against some gram-positive cocci, including Enterococcus faecalis. Carbapenems were similarly active against anaerobes, and resistant strains were rarely encountered. Meropenem, unlike imipenem or ceftazidime, was bactericidal for all strains of Enterobacteriaceae, P. aeruginosa, and gram-positive cocci tested at < or = 8 times the MIC. A lack of antibiotic cross-resistance was frequently observed between comparator-resistant strains and meropenem. These data suggest the potential utility of meropenem as a monotherapeutic agent against a broad range of pathogens.

Aminoglycosides↗
PubMed1989

The disposition and metabolism of meropenem in laboratory animals and man.

The disposition and metabolism of meropenem were studied in rats, dogs and cynomolgus monkeys following intravenous administration of [14C]-meropenem, and also in man following intravenous infusion of meropenem. Following intravenous administration to rats and dogs, radioactive material was very rapidly and widely distributed in the tissues, with highest levels detected in the kidney and other highly perfused organs. Concentrations in all tissues decreased rapidly with time. The plasma elimination half-life of meropenem was approximately 6 min in rats, 30 min in monkeys, 45 min in dogs and 1h in man. In all species 90-100% of the dose was excreted via the urine within 24 h. Analysis of the radioactive material in urine from animal studies showed that the major components were unchanged compound (36-43%) and a metabolite corresponding to a beta-lactam ring-opened form (34-51%). In man, approximately 65% of the dose was excreted in urine as unchanged meropenem and most of the remainder as the ring-opened metabolite. As part of the preclinical safety evaluation programme of meropenem, the distribution, metabolism and excretion of [14C]-meropenem were studied in the rat, dog and cynomolgus monkey after single intravenous administration at dose levels corresponding to the lower doses used in toxicity studies. In addition, the metabolism and pharmacokinetics of meropenem in human volunteers were studied.

Animals↗
PubMed1991

Pharmacokinetics of meropenem and its metabolite ICI 213,689 in healthy subjects with known renal metabolism of imipenem.

Six healthy male subjects who had received imipenem without cilastatin in previous studies, were given 500 mg meropenem as single 30 min intravenous infusions. Plasma and urine samples were collected for 12 h and meropenem and its metabolite were assayed by HPLC and RIA, respectively. The mean plasma half-life of meropenem was 0.8 h, mean plasma clearance 277 ml/min and the mean volume of distribution 20.4 l. The metabolite reached mean peak plasma concentrations of 1.5 mg/l. Renal clearance of meropenem averaged 200 ml/min. The mean urinary recovery of the metabolite was 20% and of unchanged drug 72% of the dose given. The recovery of meropenem ranged from 62.2% to 78.2% and was correlated to the urinary recovery of imipenem when given without cilastatin to the same subjects in previous studies (range 15.2-32.2%, rank correlation coefficient = 0.934). The results indicate that meropenem is much less susceptible to renal metabolism than imipenem. The inter-subject variability observed with meropenem correlates with the extent of urinary recovery of imipenem observed in previous studies with imipenem alone, indicating some susceptibility of meropenem to renal dehydropeptidase-I.

Adult↗
PubMed1995

Meropenem: a microbiological overview.

Meropenem is a parenteral carbapenem antibiotic which has excellent bactericidal activity in vitro against almost all clinically significant aerobes and anaerobes. Its high activity is explained by ease of entry into bacteria combined with good affinity for essential penicillin binding proteins, including those associated with cell lysis. Breadth of spectrum is due, in part, to stability to all serine-based beta-lactamases, including those which hydrolyse third-generation cephalosporins. Meropenem has an antibacterial spectrum which is broadly similar to that of imipenem but, whilst slightly less active against staphylococci and enterococci, it is more active against Pseudomonas aeruginosa, all Enterobacteriaceae and Haemophilus influenzae. Amongst common human pathogens, only methicillin-resistant staphylococci and Enterococcus faecium are uniformly resistant to meropenem. The meropenem MICs for penicillin-resistant Streptococcus pneumoniae are higher than for penicillin-susceptible strains but the organisms remain susceptible. Clinical susceptibility in vitro to meropenem is defined by MICs of < or = 4 mg/L, intermediate susceptibility by MICs of 8 mg/L and MICs of > or = 16 mg/L define resistance; equivalent figures for zones of growth inhibition are > or = 14 (susceptible), 12-13 (intermediate) and < or = 11 (resistant) mm. Studies in guinea pig models of systemic infection and infections localised to the lungs, urinary tract and the central nervous system, some of which used immunocompromised animals, confirm the potential of meropenem demonstrated in vitro. These factors, combined with the human plasma, tissue or urinary concentrations of meropenem which exceed modal MICs for the pathogens isolated in clinical trials for most or all of the recommended 8 h dosing interval, predict that meropenem should be efficacious in the treatment of infections at many body sites.

Animals↗
PubMed1995

Clinical evaluation of meropenem versus ceftazidime for the treatment of Pseudomonas spp. infections in cystic fibrosis patients.

Cystic fibrosis patients (children and young adults) with Pseudomonas spp. chest infections were treated with meropenem or ceftazidime. This study was the first to investigate the use of meropenem in cystic fibrosis. Meropenem was well tolerated with only transient elevations of serum transaminases. No patient experienced nausea and vomiting, even when meropenem was administered as a bolus injection. This allowed home therapy to be used. Meropenem appeared to be at least as active as ceftazidime even at the low doses used. Patients showed a greater improvement in respiratory function on meropenem than ceftazidime. Only one patient (out of 60 courses) failed to respond to meropenem (98% success rate) compared with two failures out of 21 episodes with ceftazidime (90% success rate). There was little emergence of resistance to meropenem even though some patients were treated up to eight times over a 2 year period.

Adolescent↗
PubMed1995

Safety and efficacy of meropenem in patients with septicaemia: a randomised comparison with ceftazidime, alone or combined with amikacin.

Meropenem is a new broad spectrum carbapenem antibiotic which can be administered as monotherapy for serious infections. The efficacy and safety of meropenem was compared with that of ceftazidime (alone or in combination with amikacin) in 153 patients with septicaemia who were enrolled into identical, prospective, randomised studies. Forty-five patients with infections arising from the urinary or lower respiratory tracts were given either meropenem 500 mg or ceftazidime 250-1000 mg intravenously every 8 h; 108 patients with more serious infections were given meropenem 1 g or ceftazidime 2 g every 8 h +/- amikacin 15 mg/kg/day. Overall, 71 patients received meropenem, 47 ceftazidime and 35 ceftazidime plus amikacin. Comparable clinical response rates were achieved in the meropenem and ceftazidime/amikacin groups (92% vs 94% at the end of therapy respectively). Furthermore, a satisfactory bacteriological response was obtained in all evaluable patients. The most common pathogens isolated were Escherichia coli, Streptococcus pneumoniae and Pseudomonas aeruginosa. Relapse occurred in one patient in the ceftazidime/amikacin group, who had a mixed infection of E. coli and P. aeruginosa. There were no relapses in the meropenem group. Both treatments were well tolerated and only one patient had to withdraw from the trial because of an adverse effect (rash associated with ceftazidime). In conclusion, these data confirm that meropenem monotherapy is well tolerated and is as effective as ceftazidime (alone or combined with amikacin) in the empirical treatment of septicaemia. It should prove to be a useful addition to the drugs currently available for this life-threatening disease.

Adult↗