cilastatin--imipenem-drug-combination and Respiratory-Tract-Infections

Biapenem is an injectable carbapenem antibiotic. A clinical study was designed to evaluate its efficacy and safety in the treatment of respiratory and urinary infections compared to imipenem/cilastatin.. A total of 216 patients with respiratory or urinary tract infections were enrolled into this multicenter, open-label, randomized controlled clinical study. Each patient was randomly assigned to either the treatment or control group; 106 patients in each group were included in the ITT analyses. The patients were given biapenem 300 mg or imipenem/cilastatin 500 mg/500 mg two or three times daily, i.v. g.t.t. for 7-14 days according to their conditions.. The cure and effective rates were 67.92 and 88.68% in the biapenem group and 76.02 and 93.40% in the imipenem/cilastatin group, the bacterial eradication rates were 93.83 and 98.82%, and the adverse-event rates were 6.54 and 7.41%, respectively. There were no significant differences between the two groups (p > 0.05).. Biapenem is as effective and well-tolerated as imipenem/cilastatin for the treatment of intermediate and severe bacterial infections.

Topics: Adolescent; Adult; Aged; Anti-Infective Agents; Bacterial Infections; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Female; Hospitals, Teaching; Humans; Imipenem; Male; Middle Aged; Respiratory Tract Infections; Thienamycins; Urinary Tract Infections; Young Adult

Therapeutic efficacy and the treatment days for cure of imipenem/cilastatin sodium (IPM/CS) in treatment of pulmonary infections were prospectively determined in comparison with those of beta-lactams other than carbapenems mainly ceftazidime (CAZ) or sulbactam/cefoperazone (SBT/CPZ). The overall response rate was 84.9% (62/73) in the IPM/CS group and 74.7% (56/75) in the beta-lactam group, the difference not being significant. In the subjects having underlying respiratory diseases, the response rate was 91.1% (41/45) and 73.9% (34/46) in the IPM/CS and beta-lactam groups, respectively. In patients with infections secondary to chronic respiratory disease, the rate was 91.2% (31/34) in the former group and 66.7% (24/36) in the latter group, respectively. The differences were significant for both stratified analyses. The treatment days for cure judged by the attending physician were 12.9 +/- 0.6 days in the IPM/CS group, and 14.5 +/- 0.7 days in the beta-lactam group. The difference was not, however, significant. In patients with mild to moderate infections, the treatment days for cure was 12.0 +/- 0.6 days (n = 64) in the IPM/CS group and 14.3 +/- 0.7 days (n = 70) in the beta-lactam group. In patients with underlying respiratory disease, the treatment days for cure were 11.8 +/- 0.7 days (n = 45) and 14.7 +/- 0.9 days (n = 46) in the IPM/CS and beta-lactam groups, respectively. In patients with infections secondary to chronic respiratory disease, the days were 11.1 +/- 0.7 days (n = 34) and 14.7 +/- 1.1 days (n = 36), respectively. Thus, IPM/CS therapy significantly reduced the number of treatment days until cure. There was, however, no significant difference between the two therapy groups in treatment of the patients with severe infections, those without underlying respiratory disease, or those with pneumonia and/or lung abscess. The treatment days for cure were also assessed by the members of review committee taking into consideration of body temperature, leukocyte count, and C-reactive protein. As the result, it was 6.9 +/- 0.5 days in the IPM/ CS and 10.3 +/- 0.7 days in the beta-lactam groups; respectively, and the difference was significant. Time (days) until cure was also compared between the two groups using survival time analysis, confirming a more rapid response in the IPM/CS group. Although IPM/CS therapy was associated with a shorter response time as assessed by both the attending physicians and the review committee, there were considerable dif

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Imipenem; Male; Middle Aged; Respiratory Tract Infections; Time Factors

Imipenem/cilastatin sodium (IPM/CS) was administered to 102 patients with respiratory tract infections and lung cancer. Patients with other serious diseases were excluded and a total of 73 patients were enrolled. They were divided into 12 patients who underwent surgery (operated group) and 61 who did not (non-operated group); the latter group included 28 patients treated with anticancer agents or radiation therapy (treated group) and 33 untreated patients (untreated group). IPM/CS was effective in 75% of the patients, both with and without surgery. The drug was effective in 81% of the treated group, although many of the patients had Stage III or more advanced cancer, as well as bronchial occlusion. IPM/CS was also effective in 69% of the untreated group, although many of the patients have serious infections and a PS (Performance Status) of 3 or greater. Thus, IPM/CS treatment achieved good results. Bacteriological studies showed that 3 out of 4 strains in the operated group and 16 out of 18 in the non-operated group were eliminated. Safety was evaluated in all patients. Two patients (2%) experienced side effects and two others (2%) showed abnormal clinical findings, but the symptoms were mild and resolved after discontinuation or completion of therapy. In conclusion, IPM/CS was very effective for treating respiratory infections in patients with lung cancer.

Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Carcinoma, Large Cell; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Drug Therapy, Combination; Female; Humans; Imipenem; Infusions, Intravenous; Lung Neoplasms; Male; Middle Aged; Neoplasm Staging; Opportunistic Infections; Respiratory Tract Infections

In the present study, we used the envelope method to divide patients with respiratory infections into two groups: a monotherapy group given imipenem/cilastatin sodium (IPM/CS) and a combination therapy group given imipenem/cilastatin sodium plus amikacin sulfate (AMK). We then compared the clinical efficacy and safety between groups. 1. Safety was evaluated in 83 patients in the IPM/CS group and 88 in the IPM/CS + AMK group while clinical efficacy was evaluated in 77 and 80 patients in the respective groups. 2. The overall efficacy rate was 84.4% in the IPM/CS group. Among the main infections, the efficacy rates were 82.7% in 52 cases of pneumonia (including lung abscess), 100% in cases of infected bronchiectasis, 66.7% in six cases of secondary infection of chronic respiratory disease, and 100% in four cases of chronic bronchitis. The overall efficacy rate was 83.8% in the IPM/CS + AMK group. Among the main infections, the efficacy rates were 88.1% in 59 cases of pneumonia (including lung abscess), 83.3% in 12 cases of infected bronchiectasis, and 60.0% in five cases of secondary infection of chronic respiratory disease. No significant differences in efficacies were seen between groups. 3. In the IPM/CS group, the efficacy rates were 92.3% for patients without prior antibiotic therapy in the IPM/CS group and 68.0% for those with prior therapy; in the IPM/CS + AMK group, the respective rates were 83.7% and 83.9%. In the IPM/CS group, there was a significant difference in the responses of patients with and without prior antibiotic therapy (P < 0.05). 4. Side effects were observed in six patients in the IPM/CS group (7.2%) and two patients in the IPM/CS + AMK group (2.3%). Abnormal laboratory test results were noted in 5 patients in the IPM/CS group (6.0%) and in 10 in the IPM/CS + f1p4group (11.4%). There was no significant difference in the incidence of side effects between groups and no severe adverse reactions in either group. These results indicate that IPM/CS alone produces of good response in moderate to severe respiratory infections while IPM/CS combined with AMK is useful in intractable respiratory infections.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amikacin; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Drug Therapy, Combination; Female; Humans; Imipenem; Male; Middle Aged; Respiratory Tract Infections

Multicenter noncomparative trials of intramuscular administration of imipenem/cilastatin for the treatment of a variety of infections requiring multiple-dose therapy are reviewed. Fourteen centers in the United States and 18 centers elsewhere participated in these studies. A total of 686 patients (461 evaluable) were treated worldwide. The severity of the infection was rated as moderate in 58.9%, mild in 37.2% and severe in 0.6%. The most common sites of infection were the skin and soft tissue (36.2%) and intra-abdominal (17.6%). Polymicrobial infections were relatively common (27%). Dosing regimens in evaluable patients were 500 mg every 12 h (45.1%), 750 mg every 12 h (36.2%) and 500 mg every 8 h (18.6%). The overall clinical outcome was favorable (clinical cure or improvement) for 95% or more of the evaluable patients with the various body system infections, except in gynecologic infections where 89% of the evaluable patients had a favorable outcome and for sepsis where the favorable outcome was 76%. Where data were available for analysis (skin and soft tissue infections) there was no difference in favorable clinical outcome among patients with moderate infection treated with 1.0 g/day (95% favorable) compared with 1.5 g/day (94% favorable). The overall bacteriologic eradication rate was 91%. Clinical adverse effects were similar in type but less common in frequency than those noted in other studies with the intravenous formulation, with nausea, vomiting and diarrhea being most common; no instances of seizures or confusion were observed. The laboratory adverse effects were similar to those seen in other studies with the intravenous formulation, with increased liver enzyme values the most common. The intramuscular injection was well tolerated in 87% of the patients and moderately well tolerated in 6.6%. The efficacy and low incidence of side effects of the intramuscular formulation of imipenem/cilastatin are significant advantages in the cost-effective treatment of infections.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Bacterial Infections; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Female; Humans; Imipenem; Injections, Intramuscular; Male; Middle Aged; Pelvic Inflammatory Disease; Respiratory Tract Infections; Skin Diseases, Infectious; United States; Urinary Tract Infections

In four prospective randomized clinical trials between November 1983 and March 1988, we studied 270 patients with severe bacterial infections, mainly lower respiratory tract ones. We compared ciprofloxacin and imipenem/cilastatin in the first study, ciprofloxacin and ofloxacin in the second study, ciprofloxacin and ticarcillin/clavulanic acid in the third study, and ofloxacin and cefpirome in the fourth study. A total of 90 pneumonias, 139 LRTIs, 22 septicaemias and 19 other bacterial infections were treated; the dominant pathogens were Pseudomonas aeruginosa and enterobacteria. Clinical success rates were high; cure or improvement was registered in 89% of the patients on ciprofloxacin, 89% on ofloxacin and 85% on beta-lactams. Treatment failures occurred mainly in ICU patients with terminal underlying diseases. Bacteriologically, eradication rates were high for enterobacteria and Staphylococcus aureus, but a relatively high persistence rate was seen for P. aeruginosa due to increased resistance and/or specific type and location of the infections. The incidence of side-effects was relatively high (23%-29%) which was related to careful monitoring. Adverse effects were group-specific (CNS reactions with quinolones, diarrhoea with beta-lactam antibiotics).

Topics: Cilastatin; Cilastatin, Imipenem Drug Combination; Ciprofloxacin; Clavulanic Acids; Drug Combinations; Drug Therapy, Combination; Humans; Imipenem; Ofloxacin; Pneumonia; Prospective Studies; Remission Induction; Respiratory Tract Infections; Sepsis; Ticarcillin

We studied the clinical efficacy and safety of imipenem, a broad spectrum beta-lactam antibiotic, in acute bacterial infections in 21 patients with AIDS or AIDS-related complex (ARC). Imipenem/cilastatin was administered as a 30-min intravenous infusion using a dose of 500 mg/8 h. Bacterial pathogens were isolated before treatment in 80% of cases; 87.5% of all strains were susceptible to imipenem in vitro. Treatment resulted in rapid control of the infections in 80% of patients. Clinical and laboratory adverse reactions probably related to imipenem treatment were noted in 8 patients.

Topics: Acquired Immunodeficiency Syndrome; Acute Disease; Adult; AIDS-Related Complex; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Female; Humans; Imipenem; Infusions, Intravenous; Male; Middle Aged; Respiratory Tract Infections; Risk Factors; Sepsis

Topics: Aged; Anti-Bacterial Agents; Asian People; Bacterial Proteins; beta-Lactamases; China; Cilastatin; Cilastatin, Imipenem Drug Combination; Citrobacter freundii; Drug Combinations; Drug Resistance, Multiple, Bacterial; Humans; Imipenem; Male; Microbial Sensitivity Tests; Plasmids; Respiratory Tract Infections

The clinical utility of imipenem/cilastatin sodium (IPM/CS, Tienam) was studied in 9 patients with respiratory tract infections from whom Pseudomonas aeruginosa was isolated using transtracheal aspiration. The patients treated were 6 males and 3 females, with ages between 42 and 78 years. The infections diagnosed were chronic bronchitis in 5 patients, diffuse panbronchiolitis in 2 and bronchopneumonia in 2. P. aeruginosa alone was isolated from 6 patients and concomitantly with other organisms from 3. Clinical efficacy was good in 6 patients, fairly good in 1 and poor in 2. No side effects or abnormal laboratory test values were observed, except for a slight elevation of LDH in 1 patient. From these results, it appears that IPM/CS is a clinically useful antibiotic for the treatment of respiratory tract infections caused by P. aeruginosa.

Topics: Adult; Aged; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Female; Humans; Imipenem; Lung Neoplasms; Male; Middle Aged; Pseudomonas aeruginosa; Pseudomonas Infections; Respiratory Tract Infections; Stomach Neoplasms

Imipenem/cilastatin sodium (IPM/CS) was administered to 55 patients with respiratory tract infections (RTI). A clinical evaluation of IPM/CS was carried out in 51 patients, 28 with pneumonia, 4 with pulmonary abscess, 1 with pyothorax, 6 with bronchitis, 9 with bronchiectasis, 1 with diffuse panbronchiolitis and 2 with RTI with chronic obstructive pulmonary disease, and the clinical efficacy rate was 78.4%. Causative organisms were isolated in 23 strains out of 20 patients, such as Staphylococcus aureus 4 strains, Staphylococcus epidermidis 1 strain, Streptococcus pneumoniae 1 strain, Branhamella catarrhalis 1 strain, Haemophilus influenzae 2 strains, Klebsiella pneumoniae 4 strains, Pseudomonas aeruginosa 6 strains, Pseudomonas sp. 1 strain, Acinetobacter calcoaceticus 1 strain, Acinetobacter sp. 1 strain and glucose non-fermentative Gram-negative rod 1 strain. An eradication rate of 70.6% was obtained. An overall eradication rate of main causative organisms in RTI including S. aureus, S. pneumoniae, H. influenzae and K. pneumoniae was 75.0%. Clinical adverse effects were observed in 5 patients, and these were eruption in 2, itching in 1, vomiting in 1 and drug fever in 1. Abnormalities in laboratory test results were observed in 8 patients. These disappeared or returned to normal values after completion or discontinuation of IPM/CS administration. IPM/CS appears to be a useful antibiotic for the treatment of RTI, especially severe infections.

Topics: Adult; Aged; Aged, 80 and over; Cilastatin; Cilastatin, Imipenem Drug Combination; Drug Combinations; Drug Evaluation; Drug Resistance, Microbial; Female; Humans; Imipenem; Klebsiella Infections; Male; Middle Aged; Pseudomonas; Respiratory Tract Infections; Staphylococcal Infections; Staphylococcus

Chest infections with organisms resistant to conventional antibiotics are common in patients with chronic lung disease. We have studied the use of imipenem in 40 (28 M 12 F) patients admitted for treatment of chest infections. Patients were treated with imipenem 0.5 g four times daily by intravenous infusion for 6.3 +/- 1.6 (S.D.) days. Forty-six respiratory pathogens were cultured from 36 patients including 18 Haemophilus influenzae, 6 H. parainfluenzae, 6 Streptococcus pneumoniae, 8 Pseudomonas aeruginosa, and 6 Branhamella catarrhalis. Forty-three of the 46 isolates were sensitive to imipenem, 28 to ampicillin, 33 to tetracycline and 35 to cotrimoxazole. Thirty-eight of the 40 patients improved clinically, and 34 of the 36 patients with positive sputum culture had no pathogens in their sputum after treatment. Twenty patients developed minor phlebitis at the infusion site but there were few other side effects. Imipenem may prove useful in the treatment of chest infections, particularly when the organism is resistant to conventional antibiotics.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Cilastatin; Cilastatin, Imipenem Drug Combination; Cyclopropanes; Drug Combinations; Female; Humans; Imipenem; Infusions, Intravenous; Lung Diseases, Obstructive; Male; Middle Aged; Respiratory Tract Infections; Thienamycins

Topics: Adult; Aged; Cilastatin; Cilastatin, Imipenem Drug Combination; Cyclopropanes; Drug Administration Schedule; Drug Combinations; Female; Humans; Imipenem; Infusions, Intravenous; Male; Middle Aged; Piperacillin; Respiratory Tract Infections; Thienamycins

26 patients from the surgical intensive care unit, University Hospital Lübeck, received imipenem/cilastatin for severe abdominal, respiratory or urogenital infections. 500 mg imipenem/cilastatin were infused i.v. over 30 min q. i. d. The treatment was successful in 84,6% of the patients suffering from severe infections. Two cases were considered to be failures. 36 of the 43 isolated pathogens (83.7%) were eliminated. Transitory elevations of liver enzymes were the most frequent side-reactions observed; an increase in serum creatinine, diarrhoea or fungal colonization were less common.

Topics: Abdomen; Adult; Aged; Aged, 80 and over; Bacterial Infections; Cilastatin; Cilastatin, Imipenem Drug Combination; Cyclopropanes; Drug Combinations; Female; Humans; Imipenem; Intensive Care Units; Male; Middle Aged; Postoperative Complications; Respiratory Tract Infections; Thienamycins; Urinary Tract Infections

In an open prospective study the efficacy and tolerance of imipenem/cilastatin was investigated in 24 critically ill patients on mechanical ventilation with nosocomial respiratory tract infection. Nine patients had previously received antibiotic therapy, eight of them with various other beta-lactam antibiotics which had failed. Imipenem was given in a dose of 1-3 g/24 h over 5-37 (mean 11) days. Seven patients were additionally treated with aminoglycosides, one patient with erythromycin. Pseudomonas aeruginosa (n = 14), Staphylococcus aureus (n = 4), Haemophilus influenzae (n = 4) and Escherichia coli (n = 3) were the potential pathogens most frequently isolated from tracheo-bronchial secretions. All of the isolates were susceptible to imipenem. 91% of the infections without and 77% with involvement of P. aeruginosa were successfully treated. Two patients who had not responded to previous treatment succumbed to the consequences of progressive respiratory distress syndrome. All of the gram-positive and 85% of the gram-negative pathogens (Pseudomonas not included) were eliminated in the course of therapy. By contrast, 64% of the isolates of P. aeruginosa persisted; half of these became imipenem-resistant. Nine patients showed adverse reactions including one case of pseudomembranous colitis or laboratory abnormalities which were all reversible. Imipenem/cilastatin proved highly effective and was relatively well tolerated; it is suitable as a single agent for the initial treatment of nosocomial respiratory tract infections in ventilated patients, although only with limitations in cases of infection due to P. aeruginosa.

Topics: Adolescent; Adult; Aged; Bacterial Infections; Cilastatin; Cilastatin, Imipenem Drug Combination; Cross Infection; Cyclopropanes; Drug Combinations; Female; Humans; Imipenem; Male; Middle Aged; Prospective Studies; Respiration, Artificial; Respiratory Insufficiency; Respiratory Tract Infections; Thienamycins