Abstract
Synopsis
Since an earlier review in the Journal substantial additional data have accumulated, further clarifying the in vitro activity, pharmacokinetic profile, clinical efficacy and tolerability of teicoplanin.
Recent therapeutic trials confirm the efficacy of teicoplanin in the treatment of microbiologically confirmed Gram-positive infections, including septicaemia, endocarditis, and infections of skin and soft tissue, bone and joints, and the lower respiratory tract. As teicoplanin can be administered once daily intramuscularly as well as intravenously, it has potential for outpatient treatment of severe Gram-positive infections. Teicoplanin is appropriate as treatment of patients with fever and neutropenia, but there is still controversy over the timing for introduction of glycopeptide antibiotics into therapeutic regimens. Teicoplanin is generally reserved for secondary therapy of patients with documented bacteraemia who fail to respond to initial empirical antibiotic regimens, but probably should be part of the initial empirical regimen in the setting of a high incidence of methicillin-resistant staphylococci.
Teicoplanin has a lower propensity than vancomycin to impair renal function when either drug is combined with an aminoglycoside, causes fewer anaphylactoid reactions, and appears to be of comparable efficacy. Thus, teicoplanin may be preferred to vancomycin in the treatment of Gram-positive infections, and where a glycopeptide antibiotic is deemed a necessary inclusion in a regimen for empirical treatment in patients with fever and neutropenia.
Antimicrobial Activity
Studies conducted since the previous review in the Journal have confirmed the excellent inhibitory activity of teicoplanin against Staphylococcus aureus, including isolates resistant to methicillin and oxacillin, and the general similarity of activity of teicoplanin and vancomycin. Streptococci remain highly susceptible to teicoplanin, although the relative susceptibility of coagulase-negative staphylococci to teicoplanin and vancomycin has varied.
Recent studies confirm that Clostridium species, C. difficile, C. perfringens, Peptostreptococcus species, Propionibacterium acnes, Corynebacterium jeikeium, and multiple resistant Corynebacterium Group D2 isolates are inhibited by low concentrations of teicoplanin.
The minimum bactericidal concentration (MBC) of teicoplanin was usually ≤2 dilutions greater than minimum inhibitory concentration for 90% (MIC90) of Streptococcus pneumoniae, S. aureus, S. epidermidis and in some studies also for isolates of coagulase-negative staphylococci. The in vitro bactericidal action of teicoplanin, like that of vancomycin, is slow and may be related to the availability of unbound drug.
Increasing the inoculum size from 104 to 106 colony forming units (cfu) had little effect on MIC90 of teicoplanin for a variety of Gram-positive bacteria, but an increase from 105 to 107 cfu markedly increased the MIC90. The bactericidal activity of teicoplanin and vancomycin was decreased in the presence of human blood or pooled serum. As with other glycopeptides, the MBC of teicoplanin is increased in the presence of sputum from patients with cystic fibrosis and an extract of mucoid slime from certain strains of S. epidermidis. The inhibitory activity of teicoplanin against S. epidermidis isolated from Hickman intravenous line infections was reduced when these bacteria were incorporated into fibrin clots.
Teicoplanin plus aminoglycosides exhibited inhibitory synergism against most isolates of E. faecalis, S. aureus, coagulase-negative staphylococci and enterococci.
Examination of the susceptibility of E. faecium to various antibiotics in the same hospital over a period of 22 years, revealed a significant increase in resistance to penicillin G and gentamicin, but stable susceptibility to teicoplanin and vancomycin. Types of glycopeptide resistance that have been described include enterococci highly resistant to both teicoplanin and vancomycin, enterococci with a low level of resistance to vancomycin which remain susceptible to teicoplanin (both types are inducible), and coagulase-negative staphylococci resistant to teicoplanin but susceptible to vancomycin. There are also enterococci constitutively resistant to vancomycin which remain susceptible to teicoplanin.
In animal models of Gram-positive endocarditis, teicoplanin and vancomycin similarly reduced the bacterial titre in cardiac valve vegetations examined a few hours after drug administration, but 10 days after treatment, a higher percentage of vegetations were sterilised by teicoplanin.
Pharmacokinetic Properties
Recent studies in which the duration of sample collection has been extended to 3 weeks after teicoplanin administration, have reported pharmacokinetic values different from those reported earlier.
Single dose administration of teicoplanin 6 mg/kg resulted in mean peak serum concentrations of about 43 and 12 mg/L 0.5 and 4 hours after intravenous and intramuscular injection, respectively. Steady-state trough serum teicoplanin concentrations were 14 and 23 mg/L after intravenous loading doses of 6 and 12 mg/kg 12 hourly for 2 doses, respectively, and the same dose every 24 hours thereafter. Absorption of teicoplanin after intramuscular administration was equivalent to that after intravenous injection. A loading dose of 15 mg/kg followed by 8 mg/kg daily thereafter, appears to be necessary to maintain trough serum teicoplanin concentrations above 10 mg/L in neonates.
The apparent volume of distribution at steady-state following intravenous injection of teicoplanin 6 to 15 mg/kg was about 0.8 to 1.6 L/kg; higher than reported in earlier studies which collected serum samples for a shorter period. Mean concentrations of teicoplanin in atrial appendages were 2.8 to 3.7 times those obtained simultaneously in serum, and were highest in myocardium and pericardium tissue 4 hours after a single 800mg intravenous dose. Penetration into the cerebrospinal fluid is minimal following parenteral administration, but drug concentrations in cerebrospinal fluid were >40 mg/L after intraventricular administration of teicoplanin 20mg every 24 or 48 hours.
The extent of metabolism of teicoplanin is minor (about 3%). Total body clearance of teicoplanin following intravenous administration of 3 to 30 mg/kg to healthy volunteers ranged from 10 to 13 ml/h/kg. Renal clearance was 8 to 12 ml/h/kg, indicating elimination almost entirely by renal mechanisms. Studies in which the duration of sample collection was 3 weeks after the last dose, reported an elimination half-life ranging from 155 to 168 hours after intravenous administration and of 182 hours after intramuscular injection.
Renal and total body clearance values for teicoplanin correlate with creatinine clearance, and are reduced in patients with impaired renal function. Teicoplanin is not removed from the circulation by haemodialysis irrespective of the type of dialysis membrane. In patients with a history of intravenous drug abuse treated with teicoplanin for bacterial endocarditis, mean total and renal clearance values were greater and more variable than usually reported in healthy volunteers, and elimination half-life decreased.
Therapeutic Efficacy
Therapeutic trials conducted since the earlier review of teicoplanin in the Journal, have confirmed the efficacy of the drug in the treatment of Gram-positive infections and as empirical therapy in immunocompromised patients with haematological malignancies requiring intensive chemotherapy.
Studies of the efficacy of teicoplanin in the treatment of bacteraemia and intravascular infection in patients without neutropenia remain largely noncomparative. In a recent comparative study in such patients, teicoplanin 6 mg/kg once daily and vancomycin 15 mg/kg 12-hourly were similarly effective. Used alone, teicoplanin 400 to 800mg daily achieved clinical and bacteriological cure in 84 to 93% of patients with bacteraemia caused mostly by S. aureus, and in 90 to 100% of patients with streptococcal or enterococcal endocarditis.
Clinical cure or improvement was achieved in 89 to 100% of patients with skin and soft tissue infection (caused mostly by S. aureus or S. epidermidis) treated with teicoplanin 200 to 800mg once daily intravenously or intramuscularly, either in hospital or as outpatients.
Noncomparative trials of teicoplanin (usually 6 mg/kg once daily) in patients with acute/chronic osteomyelitis or septic arthritis, caused by Gram-positive bacteria, have reported clinical cure or improvement in 83 to 100% of patients at the end of treatment. In studies that provided adequate follow-up data, complete resolution of chronic and acute osteomyelitis was maintained in 71 to 90% of patients ≥6 months after the end of treatment.
A combination of teicoplanin and ciprofloxacin was significantly more effective than either ciprofloxacin or ceftriaxone alone in resolving lower respiratory tract infections. In noncomparative trials, teicoplanin alone produced clinical cure or improvement in about 91% of patients with lower respiratory tract infections.
In the treatment of Clostridium difficile-associated diarrhoea and colitis, orally administered teicoplanin 100mg twice daily and vancomycin 500mg 4 times daily were clinically effective in 96 and 100% of patients, respectively. There was a tendency for C. difficile to persist in more patients treated with vancomycin than teicoplanin.
When used as initial therapy in patients with cancer and neutropenia, teicoplanin was of similar efficacy to vancomycin, when each drug was combined with piperacillin and tobramycin, or ceftazidime and amikacin. Teicoplanin was associated with a lower incidence of superinfection caused by Candida species, and was better tolerated, indicating that teicoplanin is a suitable substitute for vancomycin. Addition of teicoplanin to piperacillin plus amikacin did not improve clinical efficacy in one study, although the same triple regimen was superior to a combination of piperacillin, tazobactam and amikacin prior to modification, in another study. Controversy remains over the need for these drugs, since the choice of drug and the timing for introducing the antibiotic into the empirical regimen depend on local conditions.
While no survival advantage was demonstrated when all patients were treated with teicoplanin, there was an improved response in patients with Gram-positive bacteraemia. The controversy concerning routine inclusion of a specific anti-Gram-positive agent in empirical treatment of patients with neutropenia and fever has not been resolved, but it seems prudent to include teicoplanin in the initial empirical regimen where there is a high incidence of methicillin-resistant staphylococci.
Teicoplanin was efficacious for secondary treatment of patients who failed to respond to initial empirical treatment with ceftazidime alone or combined with amikacin, piperacillin plus amikacin, or a β-lactam antibiotic and an aminoglycoside.
In patients undergoing hip or knee arthroplasty, single intravenous doses of teicoplanin 400mg administered at anaesthetic induction were of similar efficacy to 4 perioperative doses of cefamandole or 5 perioperative doses of cefazolin. Prophylactic teicoplanin was superior to placebo in lowering the incidence of catheter-related Gram-positive septicaemia associated with Hickman catheter insertion.
Clinical experience with teicoplanin in neonates, infants and children is limited. However, initial data in paediatric patients with septicaemia, infections of the upper or lower respiratory tract, skin or soft tissues and in febrile paediatric patients with neutropenia, suggest that teicoplanin 6 to 10 mg/kg once daily is effective in the treatment of Gram-positive infections.
As aresult of its effectiveness against Gram-positive infections when administered once daily by intravenous or intramuscular injection, teicoplanin is suitable for outpatient administration. When administered to outpatients or to initially hospitalised patients subsequently discharged to outpatient care, teicoplanin has been used successfully to treat skin and soft tissue infection, bone and joint infections, and mediastinitis following coronary bypass surgery.
Tolerability
The generally good tolerability of teicoplanin discussed in the previous review in the Journal has been confirmed by further clinical experience. Analysis of adverse effect data from clinical trials and postmarketing experience in Europe indicate that one or more adverse events were experienced by 10.3% of 3377 patients. Allergic-type reactions occurred in 2.6% of patients, local intolerance in 1.7%, altered biochemical tests of liver and renal function in 1.7 and 0.6%, respectively, pyrexia in 0.8%, and ototoxicity in 0.3%. The incidence or type of adverse event was not influenced by patient age or teicoplanin dosage up to 10 mg/kg, but incidence of fever and rash increased at higher dosages. Importantly, teicoplanin has a lesser propensity than vancomycin to cause renal impairment (especially in combination with an aminoglycoside), and anaphylactictype reactions (‘red man syndrome’).
Dosage and Administration
Teicoplanin is administered intravenously (usually by bolus injection) or intramuscularly. In adults with normal renal function, a loading dose of 400mg (approximately 6 mg/kg) is followed by 200 to 400mg once daily. The higher dosage and intravenous route are recommended in severe infections. Patients with septic arthritis should be treated with a maintenance dose of 12 mg/kg once daily, and for empirical treatment in patients with fever and neutropenia, three 12-hourly loading doses of 6 to 12 mg/kg should be followed by 6 mg/kg once daily as maintenance therapy. In patients with endocarditis caused by S. aureus, trough serum teicoplanin concentrations Must exceed 20 mg/L when teicoplanin is used as monotherapy, although in such patients concomitant administration of an aminoglycoside for the first 1 to 2 weeks is advisable.
In children under 12 years, 3 doses of 10 mg/kg should be administered 12-hourly, followed by 6 or 10 mg/kg according to the severity of infection. In premature neonates, teicoplanin 16 mg/kg on day 1, then 8 mg/kg/day may be needed to maintain trough serum drug concentrations above 10 mg/L.
In patients with acute or chronic renal impairment, the recommended adult dosage of teicoplanin should be administered for the first few days, after which the dosage should be modified to maintain a trough serum drug concentration of >10 mg/L. Serum concentration monitoring is also necessary in patients with a history of intravenous drug abuse, to ensure therapeutic teicoplanin concentrations.
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Various sections of the manuscript reviewed by: D. Cappelletty, Department of Pharmacy Services, Wayne State University, Detroit Receiving Hospital and University Health Center, Detroit, Michigan, USA; A. W. Chow, Division of Infectious Diseases, University of British Columbia, Vancouver, British Columbia, Canada; F.D. Daschner, Institute of Environmental Medicine, University of Freiberg, Freiberg, Germany; R.N. Greenberg, Division of Infectious Diseases, University of Kentucky, Lexington, Kentucky, USA; S.L. Kang, Department of Pharmacy Services, Wayne State University, Detroit Receiving Hospital and University Health Center, Detroit, Michigan, USA; H. Lode, Krankenhaus Zehlendorf, Infektiologie und Immunologie, Heckeshorn, Berlin, Germany; F. Menichetti, Istituto di Malattie Infettive, Università di Perugia, Perugia, Italy; S. Palmer, Department of Pharmacy Services, Wayne State University, Detroit Receiving Hospital and University Health Center, Detroit, Michigan, USA; P. Peller, Klinikum Rosenheim, Ludwig-Maximilians-Universität München, Rosenheim, Germany; P. Reynolds, Department of Biochemistry, University of Cambridge, Cambridge, England; M.J. Rybak, Department of Pharmacy Services, Wayne State University, Detroit Receiving Hospital and University Medical Centre, Detroit, Michigan, USA; P. Van der Auwera, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles, Brussels, Belgium.
An erratum to this article is available at http://dx.doi.org/10.1007/BF03259119.
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Brogden, R.N., Peters, D.H. Teicoplanin. Drugs 47, 823–854 (1994). https://doi.org/10.2165/00003495-199447050-00008
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DOI: https://doi.org/10.2165/00003495-199447050-00008