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PubMedDate not supplied

Combined aztreonam and gentamicin therapy for pseudomonal lower respiratory tract infections.

A multicenter, open-label study was performed to assess the efficacy and safety of aztreonam plus gentamicin in the treatment of lower respiratory tract infections due to Pseudomonas aeruginosa. Patients with documented P aeruginosa infections were given aztreonam 2 g every 8 hours (q8h) plus gentamicin 3 to 5 mg/kg per day in three equal doses. Clindamycin, 600 mg q8h, was added to the regimen for patients with infections also involving gram-positive and/or anaerobic bacteria. Therapy was continued for at least 5 days or until obvious failure to respond to treatment. Of 64 patients with suspected P aeruginosa infections, 57 were eligible for clinical evaluation and 51 for microbiologic evaluation. At entry, impaired host defense was present in 35% of patients, and chronic obstructive pulmonary disease in 28%, in addition to other predisposing conditions such as emphysema, history of tuberculosis, and pneumothorax. The clinical response rate for the combination regimen was 48/57 (84%), which included 27 (47%) cures and 21 (37%) partial responses. The microbiologic response rate was 35/51 (69%), of which 25 (49%) outcomes were classified as eradication and 10 (20%) as eradication with relapse. Superinfection was observed in 3 (6%) patients. The combination of aztreonam and gentamicin was synergistic in the initial isolates obtained from 33 (72%) patients. A total of 16 patients died of pulmonary or other underlying disease, for a mortality rate of 28%. The monobactam-aminoglycoside combination was generally well tolerated. Two other patients were withdrawn because rashes emerged on treatment. This study demonstrates that aztreonam can be administered as one component of a synergistic monobactam-aminoglycoside therapy in the treatment of nosocomial lower respiratory tract infections involving P aeruginosa.

Adult↗

PubMed1993

Drug-induced retinal toxicity in albino rabbits: the effects of imipenem and aztreonam.

PURPOSE: To test the toxic action of two antibiotics, imipenem and aztreonam, on the functional and morphologic integrity of the albino rabbit retina. METHODS: Two commercial drugs were used--Tienam, which contains imipenem, and Azactam, which contains aztreonam. Different doses of these drugs were injected intravitreally. Retinal function was assessed from the electroretinogram (ERG) and the visual evoked potential (VEP). Retinal structure was examined at the light microscopic level. RESULTS: Imipenem did not affect the ERG and the VEP responses or the morphology of the retina up to a total injected dose of 0.98 mg (2 mg Tienam). Aztreonam was not toxic to the albino rabbit retina up to a total injected dose of 2.8 mg (5 mg of Azactam). Severe functional and morphologic retinal damage was seen when 10 mg of Azactam was injected. A similar degree of damage was seen when a dose of 5 mg L-arginine, an ingredient of Azactam, was injected into the vitreous. CONCLUSIONS: Imipenem and aztreonam are nontoxic to the albino rabbit retina at concentrations that are 500-fold higher than their effective dose against bacterial infection. Azactam is highly toxic at high levels (more than 10 mg injected into the vitreous). Most of the toxicity could be explained by the L-arginine content of the drug.

Animals↗

PubMed2026

In vitro susceptibility testing of aztreonam-avibactam against predominantly NDM-producing Enterobacterales in Peru.

Metallo-β-lactamase-producing Enterobacterales are distributed worldwide, but some Latin American countries show a higher prevalence. Aztreonam-avibactam (ATM-AVI) may be an option for treating these infections. To evaluate in vitro susceptibility to aztreonam (ATM) alone and ATM-AVI in carbapenem-non-susceptible Enterobacterales isolates, based on the type of carbapenemase production, we prospectively collected carbapenem-non-susceptible Enterobacterales isolates from Peruvian hospitals during 2023-2024. Identification and susceptibility testing were performed by commercial panels and disk diffusion. Carbapenemases were detected by immunochromatography. ATM and ATM-AVI MICs were determined using broth microdilution panels with avibactam fixed at 4 µg/mL. The non-susceptible isolates to ATM-AVI and those with double production of carbapenemases underwent whole-genome sequencing. A total of 438 Enterobacterales isolates were analyzed; carbapenemase production was detected in 422 (96.3%) and NDM was the most frequent (61.9%). Coproduction of NDM + KPC in K. pneumoniae and NDM + OXA-48-like in Escherichia coli was observed. Overall, 99.3% were susceptible to ATM-AVI; MIC50 and MIC90 were 0.12 and 2 µg/mL, respectively. Overall, K. pneumoniae isolates had lower MIC50 and MIC90 values to ATM-AVI (0.12 and 0.5 µg/mL) compared to E. coli (0.5 and 4 µg/mL). Three E. coli isolates were resistant to ATM-AVI (MIC ≥ 8 µg/mL), they belonged to ST410, ST167, and ST10 and harbored a YRIN insertion in PBP3 along with CYM-type, PER-type, and CTX-M-type beta-lactamase genes. ATM-AVI demonstrated potent activity against carbapenem-non-susceptible Enterobacterales, including those producing NDM, which is the carbapenemase most frequently detected in Peruvian hospitals.IMPORTANCEEnterobacterales isolates cause common illnesses in humans. Carbapenems are the antibiotics used to treat several of these infections, and increasingly, isolates resistant to these antibiotics are found. The most important mechanism of resistance to carbapenem among Enterobacterales is the production of enzymes called carbapenemases. Our results allowed us to recognize that NDM is the most frequent type of carbapenemase detected. Most of the antimicrobials available do not cover the Enterobacterales carrying NDM carbapenemase. In this scenario, we found that the new combination of drugs, aztreonam-avibactam, has high in vitro efficacy against most of the carbapenem-resistant isolates and against those isolates carrying NDM carbapenemase.

Aztreonam↗

PubMed1986

Aztreonam therapy for serious gram-negative infections in children.

Fifty-nine children were enrolled in an open trial of aztreonam, a monocyclic beta-lactam, therapy for serious gram-negative infections. Thirty-six infections were microbiologically evaluable and received five or more days of therapy. Patients' ages ranged from 3 days to 12 years, and diagnoses included pyelonephritis or cystitis (20), deep soft tissue or joint infection (seven), septicemia (four), pneumonia (three), peritonitis, and epiglottitis. Causative bacteria included Escherichia coli and other Enterobacteriaceae, Pseudomonas aeruginosa, and Haemophilus influenzae. The standard regimen was 30 mg/kg every six or eight hours intravenously. All isolates were aztreonam-susceptible and were eradicated during therapy. Two patients had microbiologic relapses: a patient with Salmonella choleraesuis meningitis who was initially treated for only ten days and a patient with E coli pyelonephritis. Clinical cure was achieved in 31 of 36 children. Pharmacokinetic studies performed in six children demonstrated no difference in serum concentrations or pharmacokinetic variables between day 1 and day 7 of therapy. Although several patients had transient eosinophilia (eight), elevated levels of aminotransferase (seven), or thrombocytosis (ten), no clinically significant adverse effects were noted. In this initial, uncontrolled study, aztreonam was effective and safe in the treatment of a variety of serious gram-negative infections in children.

Aztreonam↗

PubMed1990

Simultaneous derivative spectrophotometric determination of aztreonam and L-arginine in injections.

Mixtures of aztreonam, 2S-[2 alpha,3 beta(Z)]-2-[[[1-(2-amino-4-thiazolyl-2- [(2-methyl-4-oxo-1-sulfo-3-azetidinyl) amino]-2-oxo- ethylidine]amino]oxy]-2-methyl-propanoic acid, and L-arginine are assayed by peak-to-baseline, peak-to-peak, and zero-crossing second-derivative spectrophotometry. Aztreonam is the first of a new class of beta-lactam antibiotics (i.e., the mono-bactam antibiotics, highly effective against aerobic gram-negative bacteria). Beer's law is followed for up to 31 micrograms/mL of aztreonam and L-arginine in the presence of one another. Detection limits at the p = 0.05 level of significance range from 0.11 to 0.37 micrograms/mL. The method was successfully applied to laboratory mixtures and commercial injections containing these substances.

Arginine↗

PubMed2006

Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis.

BACKGROUND: Aztreonam lysinate for inhalation (AI) is a novel monobactam formulation being investigated for pulmonary Pseudomonas aeruginosa infections in patients with cystic fibrosis (CF). METHODS: Pre-clinical studies investigated the pre- and post-nebulization activity of AI and its activity in the presence of CF sputum. A double-blind, placebo-controlled, dose-escalation trial determined pharmacokinetics and tolerability of AI in subjects with CF. Single daily escalating doses of AI 75, 150, or 225 mg, or placebo were self-administered using an eFlow Electronic Nebulizer. Sputum samples were collected up to 4 hr and blood samples up to 8 hr post-dose. RESULTS: AI activity against multiple CF isolates was retained after nebulization via eFlow, and activity was not inhibited by CF sputum. All 12 adult subjects and 11/12 adolescents tolerated all AI doses. One patient had an asymptomatic FEV1 decrease > 20% with the 150 mg dose. Median aztreonam sputum concentrations in adults 10 min after AI 75, 150, and 225 mg were 383, 879, and 985 microg/g, respectively. Median sputum concentrations in adolescents 10 min after AI 75, 150, and 225 mg were 324, 387, and 260 microg/g, respectively. Systemic exposure to AI was low. Plasma pharmacokinetics in adults receiving AI 75 mg were Cmax = 419 ng/g, Tmax = 0.99 hr, t1/2 = 2.1 hr. Aztreonam concentrations in sputum were at or above the MIC50 for at least 4 hr post-dose. CONCLUSION: These data support the continued development of AI for treatment of pulmonary infections in patients with CF.

Administration, Inhalation↗

PubMed1983

Prediction of aztreonam pharmacokinetics in humans based on data from animals.

Interspecies correlations of pharmacokinetic parameters obtained in animals were used to predict human pharmacokinetics in order to design the first clinical study of an investigational drug. The serum pharmacokinetics of aztreonam, a novel monocyclic beta-lactam antibiotic, were described for mice, rats, rabbits, and monkeys, using serum clearance and apparent volume of distribution. A one-compartment pharmacokinetic model yielded predictions for aztreonam clinical pharmacokinetics that were very helpful in choosing doses and serum sampling times for the first kinetic study in healthy male volunteers. Predicted serum aztreonam concentrations agreed well with subsequently measured values in man.

Animals↗

PubMedDate not supplied

Ceftriaxone versus aztreonam plus cefazolin for infections in cancer patients with adequate neutrophil counts.

In a prospective randomized trial, 154 febrile episodes in cancer patients with adequate neutrophil counts (greater than 1,000 cells/mm3) were treated with either ceftriaxone (72 episodes) or aztreonam plus cefazolin (82 episodes). Documented infections represented almost half of the febrile episodes. The overall response rates among the 144 evaluable episodes were similar for the two regimens: 76% (51/67) with ceftriaxone versus 82% (63/77) with aztreonam plus cefazolin (p = 0.41, not significant). Although not statistically significant, the response rate of the microbiologically documented infections was slightly better in patients treated with the double beta-lactam combination (85% vs. 65%, p = 0.16) and clinically documented infections showed a better response in the group of patients receiving monotherapy (87% vs. 59%, p = 0.12). No serious adverse effects were observed during this study and both regimens were well tolerated. Ceftriaxone or the combination of aztreonam plus cefazolin showed a similar efficacy as empirical therapy for infections in cancer patients with adequate neutrophil counts.

Adolescent↗

PubMed1989

Antipseudomonal therapy in cystic fibrosis: aztreonam and amikacin versus ceftazidime and amikacin administered intravenously followed by oral ciprofloxacin.

In order to determine the optimal antipseudomonal therapy in patients with cystic fibrosis aztreonam plus amikacin was compared to ceftazidime plus amikacin, and these two-week hospital regimens were followed by oral ciprofloxacin given for four weeks. Fifty-six cases of acute pulmonary exacerbation of the disease in 42 patients associated with isolation of Pseudomonas aeruginosa from the sputum were randomly treated with either aztreonam or ceftazidime (300mg/kg/day i.v.; maximum daily dose 12g) in combination with amikacin (36mg/kg/day i.v.; maximum daily dose 1,500mg). Other aspects of the two-week treatment were constant. The two therapy groups were comparable in all respects. Both regimens were well tolerated and resulted in similar improvements in clinical, bacteriologic, radiologic and laboratory findings, and pulmonary function. Fifty patients could be reevaluated after subsequent outpatient therapy consisting of oral ciprofloxacin (30mg/kg/day; maximum daily dose 1,500mg) given for four weeks. During this period, the clinical and laboratory improvements persisted, and the rate of eradication of Pseudomonas aeruginosa from sputum decreased from 62% to 34%. Ciprofloxacin was well tolerated and there was no drug toxicity or serious adverse effect. In the 25 prepubertal patients there was neither subjective nor objective evidence of skeletal drug toxicity. In patients with cystic fibrosis, aztreonam or ceftazidime in combination with amikacin represents an effective and safe systemic anti-pseudomonal therapy. Subsequent oral ciprofloxacin therapy for four weeks prolongs the beneficial effects and is well tolerated.

Adolescent↗

PubMed2001

Emergence of cephem- and aztreonam-high-resistant Neisseria gonorrhoeae that does not produce beta-lactamase.

Regarding Neisseria gonorrhoeae, the National Committee for Clinical Laboratory Standards (NCCLS) has not defined the breakpoint minimum inhibitory concentration (MIC) for expanded spectrum cephems such as cefpodoxime and ceftizoxime, because of the absence of resistant strains to these antibiotics. To date, in gonococcal urethritis, after treatment with third generation cephems and aztreonam, clinical failures caused by resistant N. gonorrhoeae strains have not been reported. However, we experienced two clinical failures in patients with gonococcal urethritis treated with cefdinir and aztreonam. N. gonorrhoeae isolates from these two patients showed high-level MICs to these agents. The MIC of cefdinir was 1 microg/ml for both strains and that of aztreonam was 8 microg/ml for both strains, while the MICs of other beta-lactams were also higher than the NCCLS value, except for ceftriaxone, for which the MIC was 0.125 microg/ml for both strains. Moreover, the MICs of fluoroquinolones, tetracyclines, and erythromycin against these two isolates were higher than the NCCLS susceptibility value. These isolates were susceptible to spectinomycin. In N. gonorrhoeae, the emergence of these beta-lactam-resistant isolates is of serious concern. However, a more serious problem is that these isolates were already resistant to non-beta-lactam antimicrobials. In Japan, ceftriaxone has not been permitted for clinical use against gonococcal infections. Therefore, in Japan, patients with gonococcal urethritis caused by these resistant N. gonorrhoeae strains should be treated with cefodizime or spectinomycin.

Adult↗

PubMed1985

Aztreonam: the first monobactam.

A novel screening procedure led to isolation of the structurally unique, bacterially produced, monocyclic beta-lactam antibiotics early in 1979. These naturally occurring "monobactams" were not clinically useful as antibiotics because of their poor antibacterial properties. They were, however, found to interact with certain penicillin-binding proteins of bacteria and thus to interfere with the biosynthesis of bacterial cell walls. The focus of monobactam development then turned toward increasing the binding activity of the beta-lactam ring of the molecule. Aztreonam was the first compound to emerge that fulfilled the objectives of the program. It is relatively inactive against gram-positive and anaerobic bacteria but is extremely effective against aerobic gram-negative bacteria, even in low concentrations. In addition, it is highly resistant to enzymatic hydrolysis by beta-lactamases and demonstrates a high degree of stability against plasmid-mediated gram-negative lactamases. With the chromosomally mediated beta-lactamases, on the other hand, aztreonam can act either as an inhibitor or as a poor substrate. It is unique in that it does not induce production of chromosomally mediated enzymes. Interference with normal gut flora by the use of broad-spectrum antibiotics can result in decreased defense capacity and can lead to intestinal colonization by resistant pathogenic organisms. Therapy directed specifically against the invading pathogen is thus preferred. Such directed therapy is provided by aztreonam. Its narrow spectrum can, if necessary, be broadened by combining it with other antibiotics while continuing to maintain an alternative to the more generalized "shotgun" therapy with its attendant side effects such as disturbances of the natural gut flora, diarrhea, and the emergence of resistant bacteria.

Animals↗

PubMed1985

Treatment of gram-negative infections with aztreonam.

Twenty-one patients with serious gram-negative infections were treated with aztreonam. Twenty of these were clinical and microbiologic cures; there was one clinical improvement with microbiologic persistence. No bacteria became resistant. Cure rates were: bone and joint (11 of 11); skin and soft tissue (six of six); pneumonia (two of two); perinephric abscess (one of one); and intra-abdominal abscess (zero of one). The bacteria responsible for these infections included Pseudomonas aeruginosa (12), Serratia marcescens (two), Enterobacter gergoviae (three), Enterobacter aerogenes (two), Escherichia coli (one), Citrobacter diversus (one), and Hemophilus influenzae (one). Aztreonam was well tolerated. Significant serum glutamic-oxaloacetic transaminase/serum glutamic-pyruvic transaminase elevations developed in three patients, but none was symptomatic and all resolved after therapy was stopped. Two patients in whom a rash developed were receiving other antibiotics (vancomycin and metronidazole), making the cause of the rash unclear. Diarrhea developed in a single patient with Pseudomonas osteomyelitis, who also was receiving cefazolin for Staphylococcus aureus superinfection of his decubitus ulcer. Aztreonam was highly effective against gram-negative bacilli, including P. aeruginosa. The only clear-cut side effect was an asymptomatic rise in serum glutamic-oxaloacetic transaminase/serum glutamic-pyruvic transaminase levels in three patients.

Abscess↗

PubMed1985

Current state of infectious diseases--potential areas of directed therapy with aztreonam.

Gram-negative bacillary organisms have continued to be a major source of hospital infections. Beta-lactamase-producing species have rendered many older beta-lactam antibiotics impotent. Aztreonam is a monocyclic beta-lactam antibiotic that inhibits aerobic gram-negative bacilli, including beta-lactamase-producing species. The agent has been used in the treatment of infections due to Enterobacteriaceae and Pseudomonas aeruginosa. Potential areas of use of aztreonam are as sole therapy for urinary tract infections, gram-negative pneumonias, and bone and joint infections. It can be used in combination with other antibiotics as empiric therapy of respiratory, intra-abdominal, skin structure, and gynecologic infections. Aztreonam offers a new approach to the use of beta-lactam antibiotics.

Abdomen↗

PubMed1986

Aztreonam therapy in neutropenic patients with cancer.

Combinations of aztreonam/vancomycin, aztreonam/vancomycin/amikacin, and moxalactam/ticarcillin were compared in a prospective randomized trial as empiric therapy for febrile neutropenic cancer patients. Vancomycin was added to aztreonam to provide coverage against gram-positive organisms. Of 535 febrile episodes included in the study, 455 were evaluable. The aztreonam/vancomycin and aztreonam/vancomycin/amikacin combinations were both more effective than the moxalactam/ticarcillin combination in a total of 244 episodes of documented infection. The difference was due to the fact that both aztreonam-containing combinations were more effective than the moxalactam/ticarcillin combination in documented gram-positive infections. The three regimens were equally effective in 67 documented infections due to a single gram-negative bacterial species. (The response rates were 87, 86 and 94 percent for the aztreonam/vancomycin, aztreonam/vancomycin/amikacin, and moxalactam/ticarcillin combinations, respectively.) Aztreonam was effective as the single active antibiotic in the treatment of gram-negative infections in neutropenic patients; however, it must be used in combination with another antibiotic to provide gram-positive coverage.

Adolescent↗

PubMed1990

Empiric antibiotic use--aztreonam as a model.

Empiric antibiotic therapy, which accounts for over 90 percent of in-hospital therapeutic antibiotic decisions, may be defined as tentative therapy designed to decrease morbidity and mortality associated with severe infection due to unidentified bacterial pathogens. In the 48- to 72-hour interim between presentation and the availability of reliable culture and sensitivity data that allow for definitive therapy, empiric therapy is extremely important. Aztreonam, the first member of the monobactam class of monocyclic beta-lactam antibiotics, is highly active against most gram-negative aerobic bacteria, including Pseudomonas aeruginosa. Its spectrum of activity is similar to that of the aminoglycosides but without the toxicity associated with those agents. For this reason, aztreonam may play an important role in empiric therapy. Currently, it can be recommended as single-agent empiric therapy only for severe urinary tract infections, but in combination with a variety of other agents, it has proved useful against a wide range of bacterial infections, and in certain subgroups, such as penicillin-allergic patients, it may represent the treatment of choice. It is not yet clear whether aztreonam is superior to other relatively nontoxic agents, such as the third-generation cephalosporins or carbapenems, but there is little doubt that this new agent is a generally safe and effective drug for the treatment of suspected gram-negative sepsis.

Aztreonam↗

PubMed1985

Ototoxicity of subcutaneously administered aztreonam in neonatal rats.

Aztreonam (SQ 26,776) was given subcutaneously to three groups of neonatal rats at daily doses of 150, 600, and 2400 mg/kg from postnatal Days 10 through 16. Two similar groups given 400 mg of streptomycin kg-1 day-1 or 12 ml of 0.9% sodium chloride kg-1 day-1 on the same schedule served as a positive and negative control group, respectively. On postnatal Days 28 and 56, the neonates were evaluated for level of spontaneous activity and auditory and vestibular function. Half of the neonates in each group were necropsied on postnatal Day 29, and the other half on postnatal Day 57. The inner ears of all neonates were evaluated for histopathologic evidence of ototoxicity. No functional or histopathologic evidence of ototoxicity was found in any neonatal rat dosed with aztreonam or saline. However, neonates given streptomycin were hyperactive, had severely impaired hearing and vestibular function, and had morphologic changes in the sensory nerve endings of the semicircular canals, utriculus, sacculus, and cochlea. The histopathologic evidence of the ototoxic effects of streptomycin correlated highly with the functional data. Thus, under these conditions, aztreonam demonstrated no ototoxic effects in neonatal rats.

Animals↗

PubMed1993

Aztreonam.

Aztreonam is the first monobactam and is unique among beta-lactam antibiotics for its spectrum of activity that is exclusively active against gram-negative aerobic bacteria. Broad clinical experience with this agent supports its use in the treatment of adults with severe or complicated urologic infections. Aztreonam may be safely used in patients with penicillin allergy. With a spectrum of activity that is comparable to the aminoglycosides but without the potential for ototoxicity or nephrotoxicity, aztreonam represents a rational choice of therapy for treatment of systemic urinary tract infections due to susceptible organisms.

Aztreonam↗

PubMed1989

Successful use of aztreonam in a patient who failed oral penicillin desensitization.

A 69-year-old woman with Pseudomonas aeruginosa sepsis developed wheezing during the course of an oral penicillin desensitization. Despite treatment of the bronchospasm and readministration of the same dose of phenoxymethyl penicillin, wheezing recurred requiring stopping the desensitization procedure. Aztreonam, a monobactam antibiotic with activity against aerobic gram-negative bacilli, was administered along with an aminoglycoside. The patient tolerated a full course of aztreonam with no adverse reactions. This case report supports previous in vitro and in vivo studies, suggesting that aztreonam does not cross-react with penicillin-specific antibodies and that it may be well tolerated in beta-lactam-allergic individuals.

Aged↗