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59,461 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The clinical efficacy and safety of imipenem/cilastatin in the empirical treatment of adult non-immunocompromised patients with severe bacterial septicemia was studied in a prospective and open trial. The dosage of imipenem/cilastatin was 500 mg q 6 h. Of 58 patients included, 41 were evaluable for efficacy. In those patients, 35 had chronic underlying diseases and the foci of bacteremia were identified in 37; the most common ones being cardiovascular, urologic or intraabdominal infections. All isolated organisms were sensitive to imipenem with an MIC for 90% of the strains of 1 mg/l. Imipenem/cilastatin treatment resulted in rapid control of the infections in 39 of the 41 evaluable patients (95.5%). In the remaining two patients treatment had to be prematurely discontinued due to adverse effects. The causative bacterial strains were eradicated from blood in all patients who received more than one day of imipenem/cilastatin treatment but persisted sensitive to imipenem in peripheral foci in five patients (17%). Clinical and laboratory adverse reactions were noted in seven patients. In conclusion, imipenem/cilastatin was a well tolerated and effective empirical drug for treatment of septicemia.
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PMID:Efficacy and safety of imipenem/cilastatin in the empirical treatment of septicemia. 333 Oct 40

Sixty-one hospitalized infants aged one day to six months were enrolled in an open, multicenter noncomparative clinical study of the efficacy and safety of imipenem/cilastatin. Patients weighing less than 1500 g (four males/ten females, Group 1) and those greater than or equal to 1500 g (31 males/16 females, Group 2) were analyzed separately. Total daily dose (divided into b.i.d. (27) or t.i.d. (34) regimens) ranged from 50 to 101.4 mg/kg given for 10.8 days (means, range 2 to 35 days) for Group 1 and 39.7 to 103 mg/kg given for 11.2 days (means, range 1 to 41 days) for Group 2. The investigators graded the intensity of signs and symptoms of infections as moderate or severe in 86 and 91% of patients in groups 1 and 2, respectively, and bacterial pathogens were isolated pretreatment in 43 and 32% of patients. Eighty-eight percent of all bacterial pathogens were susceptible to imipenem in vitro. The most commonly isolated pathogens were Pseudomonas aeruginosa and Klebsiella pneumoniae. Patients who had confirmed bacterial infections and who did not receive concomitant antibiotics were considered evaluable for efficacy, including 6 (43%) in Group 1 and 15 (32%) in Group 2. Infection sites were (Group 1) respiratory (100%), and (Group 2) skin and skin structures (33%), urinary (11%), gastrointestinal (11%), septicemia alone (11%) and meningitis or respiratory (28% and 6% with sepsis, respectively). Safety analysis included all patients. Imipenem/cilastatin was well tolerated in 93% of Group 1 and 85% of Group 2 patients. Three patients' treatments were discontinued due to rash, oliguria or poor local tolerability. Three patients in Group 1 and four in Group 2 died; deaths were considered unrelated to imipenem/cilastatin. Results are as follows: (table; see text) In summary, 81% (17 of 21) of evaluable patients were clinically cured or improved, among whom 3 of 21 patients (14%) had serious clinical or laboratory adverse experiences which were considered possibly related to imipenem/cilastatin. These results are comparable to results reported with other single or multiple antibiotic regimens.
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PMID:Imipenem/cilastatin therapy for serious infections in neonates and infants. 333 Oct 42

One hundred and four children who were hospitalized for documented or suspected non-CNS bacterial infections (56 males/48 females, 22 days to 15 years old) were treated with intravenous imipenem/cilastatin for 9.4 days (range 3 to 28 days). Children up to three years of age received 100 mg/kg/day and older children 60 mg/kg/day, administered in four divided doses. Bacterial pathogens were isolated before therapy in 85%. Diagnoses in the 74 evaluable patients included bronchopneumonia with or without empyema (20%), peritonitis complicating appendicitis (16%), skin/soft tissue abscesses (14%), septicemia (11%) and miscellaneous other infections (39%). Among evaluable patients, 95% were clinically cured or improved. One patients, a marasmic child with pneumonitis due to pseudomonas, died during therapy. One evaluable patient each with shigellosis, Klebsiella pneumoniae empyema and streptococcal pneumonia had bacteriologic eradication or suppression but, due partly to noninfectious complications, had no overall clinical improvement. Most bacterial isolates (101/108) were eradicated, including many gram-negative and gram-positive aerobes and anaerobes; three pathogens persisted (one Proteus mirabilis and one Salmonella typhi, one Staphylococcus aureus); and one Escherichia coli pyelonephritis recurred after therapy ended too early. Imipenem/cilastatin was well tolerated by 91% of children. Clinical adverse experiences (AEs), none serious except for the one death, occurred in 19%; 12% were judged possibly related to imipenem/cilastatin, but none probably or definitely related. No serious laboratory AEs occurred; the most common AEs were eosinophilia (11%), urine discoloration, and infusion site pain. Imipenem/cilastatin is well tolerated and has excellent clinical efficacy in a wide variety of pediatric infections.
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PMID:Imipenem/cilastatin for pediatric infections in hospitalized patients. 333 Oct 43

Imipenem/cilastatin sodium (MK-0787/MK-0791) was evaluated for its safety, efficacy and pharmacokinetics in children. Thirty cases of bacterial infections were treated with MK-0787/MK-0791 at a daily dose of 40 to 222 mg/kg for 2.25 to 13 days. Clinical cure rate was 93% and bacteriological efficacy rate was 88%. Treated diseases included severe tonsillitis due to mixed anaerobic infections, pneumonia, sepsis, brain abscess and soft tissue infections. Two cases, one with periosteomyelitis due to methicillin-resistant S. aureus and the other with pulmonary abscess due to Haemophilus influenzae (other than type b), failed to respond to the MK-0787/MK-0791 therapy. The serum half-life of MK-0787 was 0.892 hour in children with normal renal functions. An episode of convulsions in a case of sepsis with bacterial croup and brain edema was considered to be associated with the MK-0787/MK-0791 therapy. From the present study, MK-0787/MK-0791 appears a safe and effective antibiotic when used in children with a variety of bacterial infections.
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PMID:[Clinical evaluation of imipenem/cilastatin sodium in children]. 346 75

Imipenem/cilastatin sodium (MK-0787/MK-0791) was administered to pediatric patients with infections, and the following results were obtained. Pharmacokinetic study Two children, 11 years of age (38 kg body weight) and 3 years of age (15.5 kg body weight), were administered by 30 minutes intravenous drip infusion a single dose of 500 mg/500 mg (13.2 mg/13.2 mg per kg) and 250 mg/250 mg (16.1 mg/16.1 mg per kg) of MK-0787/MK-0791, respectively. Serum concentrations of MK-0787 reached their peaks at the end of drip infusion at a value of 56.33 micrograms/ml and 55.98 micrograms/ml, respectively. Concentrations of the drug decreased as the time after the administration increased, and they reached 0.14 microgram/ml and 0.12 microgram/ml, respectively in the older and the younger children at 6 hours after the administration. Half-lives (T 1/2) of the drug in serum were calculated to be 1.21 hours and 1.04 hours, respectively. The concentration of the drug in cerebrospinal fluid for the 11 years old was 0.52 microgram/ml 2 hours after the drip infusion and the serum concentration at the time was 4.02 micrograms/ml. Peak serum concentrations of MK-0791 in the 2 children were 53.73 micrograms/ml and 22.99 micrograms/ml, respectively, at the end of drip infusion. After 1 hour, the serum concentration of the drug decreased to 10.54 micrograms/ml in 1 case and not detectable in the other case. Urinary recovery rates of MK-0787 in 6 hours after the drip infusion was 82.9% and 63.6% in the 2 children and those of MK-0791 were 57.9% and 74.6%. Clinical study Clinical studies on MK-0787/MK-0791 were carried out in 6 pediatric patients; 1 each with femoral cellulitis, sepsis suspected, salmonellosis, acute tonsillitis, bronchopneumonia and streptococcosis. Lengths of treatment were 2 2/3-4 days for 5 cases and 6 days for 1 case. The patients were treated by 30-60 minutes intravenous drip infusions twice a day for 1 case, and 3 times a day for 5 cases at daily doses of 54.5-66.7 mg/kg. The treatment was effective in all cases, with 3 cases judged excellent and 3 cases good. The safety of the drug was studied in 7 patients. No side effects nor clinically abnormal values were observed in any cases.
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PMID:[Clinical study on imipenem/cilastatin sodium in the field of pediatrics]. 346 80

A multicentre, non-comparative study was performed to evaluate the clinical efficacy and safety of imipenem/cilastatin given iv to 53 seriously ill patients with severe bacterial infections, including 16 episodes of UTI, 12 pleuropulmonary, eight intra-abdominal, seven osteoarticular, and two soft tissue infections, three episodes of catheter related sepsis, two primary bacteraemias, one case of endocarditis, one of endophthalmitis, and one of disseminated gonococcal infection. Twenty-five patients were bacteraemic. The overall rate of clinical response was 94% of treated episodes; three cases failed to respond. Adverse reactions were mild and comparable with those reported with other beta-lactams. No patient had clinical superinfection; colonization occurred in seven patients. Imipenem is effective and safe as a single drug therapy for a wide range of infections in seriously ill patients.
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PMID:Imipenem in the treatment of severe bacterial infections in seriously ill patients. 346 85

Imipenem and cilastatin in combination have a broad spectrum in vitro with a strong killing activity on most bacteria. Using a multicenter study design, we investigated 41 patients with moderate or severe infections: septicemia in 18 cases (Gram negative rods in 10, Gram positive cocci in 7 and combination of both in 1), pneumonia in 7, osteitis in 4, soft tissue infection in 7, infection of the genitourinary tract in 6 and miscellaneous infections in the remaining cases (1 abscess of the pancreas, 1 typhoid fever, 1 presumptive endocarditis). All of the bacteria were susceptible to imipenem/cilastatin: MICs ranged from 0.02 to 0.8 mg/l and MBCs from 0.015 to more than 10 mg/l. All patients except one recovered or improved under imipenem/cilastatin. The patient who failed to respond had septicemia due to a methicillin-resistant Staphylococcus aureus with a MBC and MIC above 10 and 0.5 mg/l respectively. Tolerance was outstanding: only 4 patients had adverse effects requiring withdrawal of the drug.
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PMID:[Treatment of moderate or severe infections using imipenem/cilastatin. 41 cases based on a multicenter protocol]. 353 23

Imipenem (N-formimidoyl thienamycin) is a new carbapenem beta-lactam antibiotic with a broad antibacterial spectrum. Forty-five patients were treated with either 500 or 1,000 mg of imipenem/cilastatin four times daily, the duration varying according to clinical response. The diagnoses were urinary tract infection, 10 patients; septicemia, six; intraabdominal sepsis, six; pneumonia, six (two cases of Legionnaires' disease); skin and soft tissue infection, four; and other diagnoses, 13. Of the 32 clinically assessable patients, 17 were cured, nine improved, three died, and three were withdrawn from the trial. Of 21 patients who were microbiologically assessable, 13 were cured. In six cases of complicated urinary tract infection, the organism--which had been eradicated from the urine during treatment--reappeared after completion of antibiotic therapy. Two patients developed adverse clinical reactions that were thought to be drug-related (drug-induced fever and nausea plus vomiting, respectively). Both patients had mildly abnormal results in liver function tests, and one developed a positive direct Coombs' test. Fifty-seven percent of the patients developed some degree of phlebitis, which was moderate to severe in 19%. In this study imipenem/cilastatin proved to be a highly effective agent for the treatment of a variety of serious bacterial infections.
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PMID:Imipenem/cilastatin in the treatment of serious bacterial infections. 390 Dec 12

Imipenem (N-formimidoyl thienamycin) is the first representative of a new class of beta-lactam antibiotics--the carbapenems. Imipenem has an unusually broad spectrum, high potency, and no cross-resistance with other beta-lactam antibiotics. Susceptible gram-negative species include Pseudomonas aeruginosa, Serratia, and Enterobacter. Activity is high against Staphylococcus aureus, most group D streptococci, and Staphylococcus epidermidis but is variable against methicillin-resistant S. aureus. Imipenem is more active against Bacteroides than are other beta-lactam agents, chloramphenicol, metronidazole, and clindamycin. The minimal inhibitory concentrations (MICs) for 98% of 30,655 isolates--excluding those of the three resistant species (Pseudomonas maltophilia, Pseudomonas cepacia, and Streptococcus faecium)--were less than 8 micrograms/ml, the susceptibility breakpoint adopted for clinical trials. Imipenem is bactericidal (minimal bactericidal concentrations (MBCs] less than twice the MICs). For P. aeruginosa, MBCs of imipenem are less influenced by high inoculum density rather than are MBCs of antipseudomonal penicillins and cephalosporins. Stability of imipenem to diverse classes of plasmid-mediated and chromosomal beta-lactamases accounts for its lack of cross-resistance with other beta-lactam antibiotics. Imipenem is also active against P. aeruginosa with non-lactamase-mediated resistance to classical beta-lactam agents. Efficacy of imipenem was shown in animal models, including septicemia in normal and neutropenic rodents and P. aeruginosa pneumonia. Imipenem also has a unique postantibiotic effect against P. aeruginosa in vivo.
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PMID:Antibacterial activity of imipenem: the first thienamycin antibiotic. 393 Nov 96

Imipenem is the first of a new class of beta-lactam antimicrobial agents with remarkable and extremely potent in vitro activity against most commonly isolated bacterial pathogens, including Staphylococcus aureus, enterococcus, members of the family Enterobacteriaceae, Pseudomonas aeruginosa, Bacteroides fragilis, and Hemophilus influenzae. The clinical efficacy and toxicity of imipenem were evaluated in 35 patients with 38 different infections. The overall clinical response was favorable (infections cured or improved) in 89% of the infections (34 of 38). Of the 17 infections with P. aeruginosa, 15 were cured or improved. However, P. aeruginosa isolates resistant to imipenem emerged during the therapy of six infections, and two cases of P. aeruginosa septicemia later relapsed after imipenem therapy. Gastrointestinal toxicity (nausea with or without emesis) occurred in 17% of the patients (6 of 35) but was ameliorated by slowing the rate of intravenous infusion or lowering the dose of imipenem. Except for certain severe P. aeruginosa infections, imipenem is effective and relatively safe therapy for infections caused by susceptible organisms.
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PMID:Imipenem therapy of Pseudomonas aeruginosa and other serious bacterial infections. 659 61


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