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PubMed1992

Efficacy of tobramycin-soaked collagen shields vs tobramycin eyedrop loading dose for sustained treatment of experimental Pseudomonas aeruginosa-induced keratitis in rabbits.

We compared the efficacy of a fortified tobramycin-soaked collagen shield to the efficacy of a single loading dose (four 50-microliters drops) of fortified tobramycin eyedrops in the treatment of New Zealand White rabbits with Pseudomonas aeruginosa-induced keratitis. Eyedrop loading-dose efficacy was evaluated with and without lateral tarsorrhaphy. Six hours after a single treatment, significantly fewer Pseudomonas colonies were present in the corneas of all three drug-treated groups as compared to the number of colonies in the corneas of balanced salt solution-treated control rabbits (P less than .006). Although no significant difference was observed between any of the drug-treated groups, lateral tarsorrhaphy was associated with a greater than tenfold decrease in the number of colony-forming units (P = .073). We found no significant difference in efficacy between a collagen shield presoaked in tobramycin, and a single loading dose of tobramycin eyedrops, in the treatment of rabbits with P. aeruginosa-induced keratitis.

Administration, Topical↗
PubMed1988

Wound and serum levels of tobramycin with the prophylactic use of tobramycin-impregnated polymethylmethacrylate beads in compound fractures.

Antibiotic-impregnated polymethylmethacrylate (PMMA) beads have been useful in treating orthopedic infections. Local delivery has been reported to establish wound antibiotic levels well above the therapeutic range while avoiding serum levels associated with increased incidence of side effects. After operative debridement, 70 patients with compound fractures were treated prophylactically with tobramycin-impregnated PMMA beads. Observations of antibiotic levels in 27 patients demonstrated antibiotic levels in the wound drainage and clot that were significantly in excess of the usual therapeutic range for tobramycin and simultaneous nontoxic serum levels. Significant levels of tobramycin can be achieved in the extracellular fluid at the fracture site when tobramycin-impregnated PMMA beads are placed in the wound after irrigation and debridement.

Debridement↗
PubMed1983

Renal function in patients treated with tobramycin-cefuroxime or tobramycin-penicillin G.

In order to evaluate the potentiating effect of cefuroxime on tobramycin nephrotoxicity 21 immunocompromised patients with suspected septicaemia were randomized to treatment with either tobramycin + cefuroxime or tobramycin + penicillin G. 51Chromium-EDTA clearance, serum creatinine, serum beta 2-microglobulin, urinary, alanine aminopeptidase, urinary N-acetyl-beta-D-glucosaminidase and urinary beta 2-microglobulin were measured during a nine day course of the antibiotic combinations. Enzymuria and a small but significant decrease of 51Chromium-EDTA clearance of equal magnitude in both treatment groups occurred. However the results cannot be extrapolated to other doses and treatment times than used in the study.

Cefuroxime↗
PubMed1990

Double-blind study of endotracheal tobramycin in the treatment of gram-negative bacterial pneumonia. The Endotracheal Tobramycin Study Group.

A prospective, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of endotracheal tobramycin (ETT) for treatment of gram-negative bacterial pneumonia. Patients were randomized to either 40 mg of tobramycin or a placebo instilled endotracheally every 8 h. Patients also received intravenous tobramycin plus either cefazolin or piperacillin. Of 85 patients enrolled, 41 were assessable. Most microbiologic diagnoses were made by endotracheal aspiration with strict grading criteria. The clinical-radiographic responses of patients and standard demographic data were recorded. Pseudomonas aeruginosa, "multiple pathogens," and Klebsiella-Enterobacter-Serratia-Citrobacter species were isolated in 41, 32, and 15% of the instances, respectively. Causative pathogens were eradicated from sputum significantly more frequently by patients who received ETT (P less than 0.05). However, no significant differences were noted in the clinical outcomes of the two study groups. No local adverse reactions attributable to the administration of this agent were observed, but four patients had supraventricular tachycardia, compared with none who received the placebo (P = 0.053). ETT may be considered as adjunctive therapy for seriously ill individuals.

Adult↗
PubMed1975

Empiric therapy for cancer patients: comparative study of ticarcillin-tobramycin, ticarcillin-cephalothin, and cephalothin-tobramycin.

Three combinations of antibiotics (cephalothin-tobramycin, cephalothin-ticarcillin, and ticarcillin-tobramycin) were administered empirically to 186 patients with cancer who were suspected of having a life-threatening infection. In approximately one-half of these patients, gram-negative infection was documented bacteriologically and consisted of septicemia in 50% of these patients. The three antimicrobial regimens were similarly effective and resulted in a favorable clinical response in approximately 55% of the patients. The administration of the cephalothin-tobramycin combination was associated with a significantly higher frequency of nephrotoxicity than that of the other two regimens.

Anti-Bacterial Agents↗
PubMed1978

Radioimmunoassay for serum tobramycin levels using 125I-labeled tobramycin.

A radioimmunoassay is described for the measurement of tobramycin in serum or plasma. The technique has advantages over other assay techniques with regard to precision, specificity, sensitivity and rapidity. The radioimmunoassay uses a tracer labelled with 125Iodine. The iodination technique is simple and gives tracer in high yield, at high specific activity and with complete immunological identity to unlabelled tobramycin. There is a significant correlation between the results obtained by this radioimmunoassay and by the disc-plate assay. Such knowledge of serum levels of tobramycin assists the clinician in regulating drug dosage to obtain an optimum therapeutic effect, and yet avoids toxic serum levels.

Acylation↗
PubMed1999

Piperacillin/tazobactam plus tobramycin versus ceftazidime plus tobramycin as empiric therapy for fever in severely neutropenic patients.

The objective of this trial was to evaluate the potential advantages of the combination of piperacillin and tazobactam in the control of fever in neutropenic patients. In this single-center study, patients who experienced a total of 247 febrile episodes were prospectively randomized to receive either our standard regimen, ceftazidime 3 g/day (1 g t.i.d.) plus tobramycin 3 mg/kg per day (1.5 mg/kg b.i.d.), or piperacillin 12 g/day plus tazobactam 1.5 g/day (4 g+0.5 g t.i.d.) plus tobramycin 3 mg/kg per day (1.5 mg/kg b.i.d.). Vancomycin was added in all cases of persistent fever in the ceftazidime arm, but only when there was microbiologically documented resistance in the piperacillin/tazobactam arm. All 247 episodes were evaluable by "intent-to-treat" analysis. The two populations were well matched in terms of age, gender, underlying disease, chemotherapy received, oral decontamination, clinical and bacterial documentation, and severity and duration of neutropenia. Initial antibacterial therapy was successful (apyrexia at 72 h, without antibiotic change) more frequently (P = 0.008) with the regimen containing piperacillin/tazobactam (54.4%) than with the one including ceftazidime (37.6%). Fewer (P = 0.02) major infectious events (infectious death or delay in treatment of underlying disease due to infection) were observed during piperacillin/ tazobactam treatment (2.6%) than with the ceftazidime regimen (11.3%), despite a lower frequency of glycopeptide addition when piperacillin/tazobactam was used (54.4% versus 77.4%) according to the rules adopted. This trial confirmed the efficacy of the piperacillin/tazobactam combination for empirical treatment of febrile neutropenic patients. This antibiotic combination permitted a dramatic decrease in empiric glycopeptide antibiotic administration in such patients.

Adult↗
PubMed1983

Clinical and bacteriological responses to three antibiotic regimens for acute exacerbations of cystic fibrosis: ticarcillin-tobramycin, azlocillin-tobramycin, and azlocillin-placebo.

In a randomized, double-blind study, cystic fibrosis patients 11-30 years of age with an acute exacerbation of their pulmonary disease were treated with either ticarcillin-tobramycin, azlocillin-tobramycin, or azlocillin-placebo for 10 days. There was significant improvement in Shwachman scores and pulmonary function tests. Concentrations of sputum bacteria were significantly reduced, but after therapy patients had a mean of 10(7) bacteria/ml of sputum. Pseudomonas was transiently eliminated in only one patient. The three regimens had similar impacts on pulmonary function and sputum bacterial concentration. Antibiotic resistance was noted more frequently in the azlocillin-placebo group, but this trend was not statistically significant. Improvement in pulmonary function did not correlate with bacteriological response. Four weeks after discharge, 62% of the improvement in forced expiratory volume in one second and 75% of the improvement in vital capacity remained, but concentrations of sputum bacteria had returned to pretreatment levels, and antibiotic-resistant bacteria persisted.

Acute Disease↗
PubMed2006

Once-daily tobramycin in cystic fibrosis: better for clinical outcome than thrice-daily tobramycin but more resistance development?

OBJECTIVES: Once-daily administration of aminoglycosides in cystic fibrosis (CF) patients is considered equally efficacious and potentially less nephrotoxic than dosing three times a day. However, the choice of the most suitable PK/PD index (C(max)/MIC versus AUC(24)/MIC) to ensure optimum clinical outcome in this patient population is not clear. PATIENTS AND METHODS: In a single-centre, open, randomized, controlled, non-blinded study 33 adult CF patients (20 females, 19-37 years) were treated with intravenous tobramycin (10 mg/kg/day) for 14 days given either as single dose once a day (Q24; 17 patients) or divided into three equal doses every 8 h (Q8; 16 patients). Tobramycin serum concentrations and MICs for Pseudomonas aeruginosa were determined on days 1 and 14. The clinical outcome parameter, correlated to PK/PD indices, was the percentage predicted forced expiratory volume in 1 s (FEV(1)% pred.). RESULTS: FEV(1)% pred. improved significantly for both treatments. There was a log-linear relationship between C(max)/MIC and FEV(1)% pred. and AUC/MIC and FEV(1)% pred. for both treatments. For equal values of AUC24/MIC, however, Q24 treatment provided better improvement in lung function than Q8 dosing, whereas C(max)/MIC did not show any dosing interval dependence. A statistically significant increase was observed for MIC (day 1) versus MIC (day 14) for Q24 treatment, however, no such difference was observed for Q8 treatment. CONCLUSIONS: The most important PK/PD parameter for clinical outcome in CF patients was C(max)/MIC. Outcome prediction of AUC(24)/MIC was dependent on the regimen. The increase of P. aeruginosa resistance after once-daily administration is linked to a long dosing interval. More and larger studies are needed to optimize the dosing regimen for maximum clinical outcome with minimum resistance development.

Adult↗
PubMedDate not supplied

Ketorolac-tobramycin combination vs fluorometholone-tobramycin combination in reducing inflammation following phacoemulsification cataract extraction with scleral tunnel incision.

OBJECTIVE: The objective of this study was to compare the efficacy of ketorolac-tobramycin combination with fluorometholone-tobramycin combination in the control of ocular inflammation after endocapsular phacoemulsification cataract surgery with scleral tunnel incision. PATIENTS AND METHODS: This was a prospective, randomized, investigator masked, 2-week, single-center study. Ocular examinations were carried out preoperatively and postoperatively on days 1 (baseline), 2, 3, 7, and 14. There were 60 patients (30 in each treatment group) undergoing uncomplicated cataract-lens implant surgery enrolled and randomized in the study. The baseline parameters were similar in the two study groups. At each visit comprehensive ocular examinations were performed and a 4-point (0 to 3) grading system was used to record findings of the burning/stinging sensation, blurred vision, ocular discomfort, conjunctival hyperemia, anterior chamber flare, and anterior chamber cells. RESULTS: There was no statistically significant difference between the treatment groups in the findings of the ocular inflammation at any of the postoperative visits. Both treatments were equally well tolerated. CONCLUSIONS: This study suggests that ketorolac may be an alternative to some corticosteroids (fluorometholone). It is generally accepted that fluorometholone is not as potent an anti-inflammatory as prednisolone the most commonly used steroid following cataract extraction.

Administration, Topical↗
PubMed1979

Pseudomonas aeruginosa keratitis treated with ticarcillin and tobramycin.

A corneal ulcer, infected with Pseudomonas aeruginosa and complicated by conjunctivitis and endophthalmitis, was treated successfully with systemic administration of ticarcillin and topical application of tobramycin. It is unlikely that carbenicillin, to which the organism was much less sensitive, would have attained sufficient tissue levels to control the infection.

Aged↗
PubMed2002

Falsely elevated serum tobramycin levels in a patient receiving nebulised tobramycin.

It is common when treating patients with respiratory exacerbations of cystic fibrosis to use both nebulised and intravenous antibiotics. Aminoglycoside drug levels are often measured from finger-prick blood samples. We describe a case of a 14-year-old girl treated simultaneously with IV and nebulised tobramycin in whom drug levels, measured from finger prick blood samples, were erroneously high due to finger contamination by the nebulised drug. Special precautions or direct venepuncture is essential when assessing antibiotic levels in such patients.

Administration, Inhalation↗
PubMed1980

Prospective, randomized, double-blind comparison of metronidazole and tobramycin with clindamycin and tobramycin in the treatment of intra-abdominal sepsis.

In a prospective, double-blind study, clindamycin was compared with metronidazole, each combined with tobramycin and all by the intravenous route in the treatment of intra-abdominal sepsis. Twenty-three patients received clindamycin and 34 patients received 35 courses of metronidazole. Analysis of the clinical responses of patients indicates that the two antibiotic regiments are of equal efficacy in that there was no difference between them in terms of defervescence or duration of infection. Few adverse effects were noted, and all appeared to be of a minor nature.

Abdomen↗
PubMed2005

The efficacy and safety of meropenem and tobramycin vs ceftazidime and tobramycin in the treatment of acute pulmonary exacerbations in patients with cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is characterized by chronic pulmonary infection with acute pulmonary exacerbations (APEs) requiring IV antibiotic treatment. We report on a blinded comparative trial of IV meropenem (40 mg/kg to 2 g q8h) or ceftazidime (5 mg/kg to 2 g q8h), each of which was administered with IV tobramycin (at a serum peak of > or = 8 microg/mL and a trough of < 2 microg/mL), as treatment for CF patients with APEs. METHODS: Patients who were > or = 5 years of age who were infected with ceftazidime-susceptible Pseudomonas aeruginosa were stratified by lung function and randomized to treatment with meropenem/tobramycin or ceftazidime/tobramycin. Patients infected with Burkholderia cepacia complex or ceftazidime-resistant P aeruginosa were assigned to receive open-label meropenem/tobramycin. Clinical response was assessed by spirometry to determine the change in percent predicted FEV1 and by a clinical acute change score (ACS). RESULTS: One hundred two patients were randomized to meropenem/tobramycin (n = 50) or ceftazidime/tobramycin (n = 52). Nineteen patients received open-label meropenem/tobramycin. FEV1 was improved at the end of treatment (EOT) with meropenem/tobramycin (mean [+/- SD] increase, 38.8 +/- 52.3%) and with ceftazidime/tobramycin (mean increase, 29.4 +/- 35.1%; p < 0.0001 vs baseline values). The proportion of patients with > or = 15% relative increase from baseline FEV1 (satisfactory response) at day 7 was 62% for the meropenem/tobramycin group and 44% for the ceftazidime/tobramycin group (p = 0.04). The median time to FEV1 response was 4 days for meropenem/tobramycin therapy vs 6 days for ceftazidime/tobramycin therapy. Similarly, FEV1 improved in the open-label group (mean increase, 12.5 +/- 25.7%; p = 0.05). ACS improved in all three groups at EOT (p < 0.0001 vs baseline values). CONCLUSIONS: Therapy with both meropenem/tobramycin and ceftazidime/tobramycin improved pulmonary and clinical status and reduced sputum bacterial burden in CF patients with APEs. A larger proportion of patients receiving meropenem/tobramycin therapy demonstrated a satisfactory FEV1 response at day 7. Resistant P aeruginosa emerged infrequently during treatment with both regimens.

Adolescent↗
PubMed1976

Tobramycin: a review of its antibacterial and pharmacokinetic properties and therapeutic use.

SYNOPSIS: Tobramycin is a new aminoglycoside antibiotic with a broad antibacterial spectrum in vitro, and pharmacokinetic properties similar to those for gentamicin. Tobramycin is more active than gentamicin against Pseudomonas aeruginosa and active against many gentamicin resistant strains, but is not active against enterobacteriaceae resistant to gentamicin. Theoretically, tobramycin has an advantage over gentamicin against infections caused by P. aeruginosa, but any advantage in clinical practice has yet to be adequately demonstrated. Clinical experience with tobramycin is considerably less than with gentamicin. Whilst tobramycin appears to offer no clear advantages over gentamicin against sensitive organisms it is indicated in infection caused by strains of P. aeruginosa which are resistant to gentamicin, but sensitive to tobramycin. Like gentamicin, tobramycin acts synergistically with corbenicillin and the cephalosporins. The efficacy of the tobramycin-carbenicillin combination has been shown in endocarditis caused by P. aeruginosa which was unresponsive to gentamicin plus carbenicillin. Ototoxicity and nephrotoxicity similar to that seen with other animoglycosides have been encountered in therapeutic trials with tobramycin and wider clinical experience is necessary to determine the relative incidence of these side-effects with gentamicin and tobramycin used under similar conditions. Antimicrobial activity: In comparative studies, in vitro, tobramycin is more active than gentamicin against clinical isolates of Pseudomonas aeruginosa. Similarly, the inhibitory index, which is the ratio between the serum concentration attained at usual therapuetic doses and the minimum inhibitory concentration, for Pseudomonas aeruginosa is higher for tobramycin than for gentamicin. Against Gram-negative bacteria other than Pseudomonas spp. the spectrum of activity of tobramycin is similar to that of gentamicin. For most species the activity of tobramycin is slightly less than that of gentamicin. Gentamicin is consistently more active than tobramycin against Serratia marcescens. Like other aminoglycoside antibiotics, tobramycin is active in vitro in low concentrations against Staphylococcus aureus. Tobramycin is essentially inactive against Streptococcus pyogenes, Streptococcus faecalis and Streptococcus pneumoniae (pneumococci). Maner aminoglycosides and of other antibiotics against various bacteria in vitro, but comparisons between studies cannot always be interpreted literally because the activity of many antibiotics in vitro, including tobramycin, is influenced by the nature of the culture media and the presence of certain salts. The sensitivity of P. aeruginosa to tobramycin is influenced by the magnesium, and calcium content of the culture media whilst that of all species is reduced by sodium ions. Wide variations in the concentration of these ions may result in divergent MIC values and an inappropriate choice of antibacterial agent to treat pseudomonas infection...

Adult↗
PubMed1982

Temperature dependence of the stability of tobramycin mixed with penicillins in human serum.

The stability of tobramycin in pooled human serum when combined with ampicillin, carbenicillin disodium, or penicillin G potassium after storage at 0, 23, or 37 degrees C was evaluated. Samples of pooled human serum containing tobramycin sulfate 8 micrograms/ml alone or combined with ampicillin, carbenicillin disodium, or penicillin G potassium 200 micrograms/ml were prepared and stored at 0, 23, and 37 degrees C. Single samples were removed periodically for 48 hours and frozen until assayed. Tobramycin concentration was measured by a radioenzymatic assay. A tobramycin degradation rate constant was calculated for the tobramycin control and each tobramycin-penicillin combination at each temperature; from this, the time for the tobramycin concentration to decline to 90% of the initial concentration (t90) was estimated. Stability of the penicillins was not assessed. Tobramycin degradation approximated a log-linear process in all samples for the 48-hour period. The tobramycin control sample was more stable than any of the tobramycin-penicillin solutions at each temperature. At 0 degrees C, tobramycin mixed with ampicillin was the least stable of all mixtures; at 23 and 37 degrees C, tobramycin mixed with carbenicillin was the least stable. Storing tobramycin and carbenicillin samples on ice (0 degrees C) prolonged t90 from 10 hours (23 degrees C) and 12 hours (37 degrees C) to 36 hours. The t90 values for tobramycin when mixed with ampicillin were 19, 16.5, and 20 hours at 0, 23, and 37 degrees C, respectively. Mixed with penicillin G, tobramycin t90 values at 0, 23, and 37 degrees C were 48, 44, and 16 hours, respectively. More than a 10% loss of tobramycin potency occurred in some tobramycin-penicillin solutions under the conditions of this study. Because this loss would affect the accuracy of tobramycin pharmacokinetic calculations, the authors suggested guidelines for handling tobramycin serum samples.

Anti-Bacterial Agents↗