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James H. Holmes – One of the best experts on this subject based on the ideXlab platform.

  • systemic absorption of Amphotericin b with topical 5 mafenide acetate Amphotericin b solution for grafted burn wounds is it clinically relevant
    Burns, 2010
    Co-Authors: Rachel A Pendleton, James H. Holmes
    Abstract:

    Abstract Objective To determine if patients receiving topical Amphotericin B in combination with 5% mafenide acetacetate solution will acquire systemically detectable levels of Amphotericin B. Methods A prospective, observational study of consecutive patients from May 2007 to March 2008 who received 5% mafenide acetacetate/Amphotericin B (2 mcg/ml) solution topically every 4 h to their excised and grafted burn wounds for at least 5 days. Serum Amphotericin B levels were measured every 5 days during treatment. In addition, the percentage of graft take, occurrence of infection, and potential adverse reactions or toxicities were monitored and recorded. Results A total of 27 patients were enrolled, accumulating 420 treatment days and 72 Amphotericin B levels. Sixty-nine of the Amphotericin B levels were undetectable, while 3 were detectable at non-therapeutic levels ( Conclusions We conclude that 5% mafenide acetacetate/Amphotericin B (2 mcg/ml) solution, applied to excised and grafted burn wounds, does not produce clinically relevant serum levels of Amphotericin B. Based on our observations, this topical regimen is safe.

  • Systemic absorption of Amphotericin B with topical 5% mafenide acetate/Amphotericin B solution for grafted burn wounds: Is it clinically relevant?
    Burns, 2009
    Co-Authors: Rachel A Pendleton, James H. Holmes
    Abstract:

    Abstract Objective To determine if patients receiving topical Amphotericin B in combination with 5% mafenide acetacetate solution will acquire systemically detectable levels of Amphotericin B. Methods A prospective, observational study of consecutive patients from May 2007 to March 2008 who received 5% mafenide acetacetate/Amphotericin B (2 mcg/ml) solution topically every 4 h to their excised and grafted burn wounds for at least 5 days. Serum Amphotericin B levels were measured every 5 days during treatment. In addition, the percentage of graft take, occurrence of infection, and potential adverse reactions or toxicities were monitored and recorded. Results A total of 27 patients were enrolled, accumulating 420 treatment days and 72 Amphotericin B levels. Sixty-nine of the Amphotericin B levels were undetectable, while 3 were detectable at non-therapeutic levels ( Conclusions We conclude that 5% mafenide acetacetate/Amphotericin B (2 mcg/ml) solution, applied to excised and grafted burn wounds, does not produce clinically relevant serum levels of Amphotericin B. Based on our observations, this topical regimen is safe.

P C Gotzsche – One of the best experts on this subject based on the ideXlab platform.

  • Amphotericin b lipid soluble formulations versus Amphotericin b in cancer patients with neutropenia
    Cochrane Database of Systematic Reviews, 2014
    Co-Authors: H K Johansen, P C Gotzsche
    Abstract:

    Background Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. Objectives To compare the benefits and harms of lipid soluble formulations of Amphotericin B with conventional Amphotericin B in cancer patients with neutropenia. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 4, 2007, PubMed (November 2007) and the reference lists of articles. We searched the proceedings of the ICAAC (from 1990 to 2007), General Meeting of the ASM (from 1990 to 2007), and the European Congress of Clinical MicrMicrobiology and Infectious Diseases (1995 to 2007) and contacted researchers in the field. For the 2011 update we searched PubMed from 1966 to 18 July 2011 and the reference lists of articles. Selection criteria Randomised clinical trials comparing lipid soluble formulations of Amphotericin B with conventional Amphotericin B. Data collection and analysis The two review authors independently assessed trial eligibility, risk of bias and abstracted data. Main results We found 12 trials (1895 patients). Lipid-based Amphotericin B was not more effective than conventional Amphotericin B for mortality (relative risk (RR) 0.83, 95% confidence interval (CI) 0.62 to 1.12), but decreased invasive fungal infection (RR 0.65, 95% CI 0.44 to 0.97), nephrotoxicity, defined as a 100% increase in serum creatinine (RR 0.45, 95%CI 0.37 to 0.54), and number of dropouts (RR 0.78, 95%CI 0.62 to 0.97). For the drug used in most patients, AmBisome (3 trials, 1149 patients), there was no significant difference in mortality (RR 0.74, 95% CI 0.52 to 1.07) whereas it tended to be more effective than conventional Amphotericin B for invasive fungal infection (RR 0.63, 95% CI 0.39 to 1.01, P = 0.053). AmBisome, Amphotericin B in Intralipid (6 trials, 379 patients), Amphotericin B colloidal dispersion (ABCD) (2 trials, 262 patients), and Amphotericin B lipid complex (ABLC) (1 trial, 105 patients) all decreased the occurrence of nephrotoxicity, but conventional Amphotericin B was rarely administered under optimal circumstances. For the 2011 update no additional trials were identified for inclusion. Authors’ conclusions It is not clear whether there are any advantages of lipid-based formulations if conventional Amphotericin B is administered under optimal circumstances and their high cost prohibits routine use in most settings. There is a need for large trials comparing lipid-based formulations of Amphotericin B with conventional Amphotericin B given in the same dose, with routine premedication for prevention of infusion-related toxicity, and with supplementation with fluid, potassium and magnesium for prevention of nephrotoxicity.

  • The Cochrane Library – Amphotericin B lipid soluble formulations versus Amphotericin B in cancer patients with neutropenia
    The Cochrane database of systematic reviews, 2014
    Co-Authors: H K Johansen, P C Gotzsche
    Abstract:

    Background Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. Objectives To compare the benefits and harms of lipid soluble formulations of Amphotericin B with conventional Amphotericin B in cancer patients with neutropenia. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 4, 2007, PubMed (November 2007) and the reference lists of articles. We searched the proceedings of the ICAAC (from 1990 to 2007), General Meeting of the ASM (from 1990 to 2007), and the European Congress of Clinical MicrMicrobiology and Infectious Diseases (1995 to 2007) and contacted researchers in the field. For the 2011 update we searched PubMed from 1966 to 18 July 2011 and the reference lists of articles. Selection criteria Randomised clinical trials comparing lipid soluble formulations of Amphotericin B with conventional Amphotericin B. Data collection and analysis The two review authors independently assessed trial eligibility, risk of bias and abstracted data. Main results We found 12 trials (1895 patients). Lipid-based Amphotericin B was not more effective than conventional Amphotericin B for mortality (relative risk (RR) 0.83, 95% confidence interval (CI) 0.62 to 1.12), but decreased invasive fungal infection (RR 0.65, 95% CI 0.44 to 0.97), nephrotoxicity, defined as a 100% increase in serum creatinine (RR 0.45, 95%CI 0.37 to 0.54), and number of dropouts (RR 0.78, 95%CI 0.62 to 0.97). For the drug used in most patients, AmBisome (3 trials, 1149 patients), there was no significant difference in mortality (RR 0.74, 95% CI 0.52 to 1.07) whereas it tended to be more effective than conventional Amphotericin B for invasive fungal infection (RR 0.63, 95% CI 0.39 to 1.01, P = 0.053). AmBisome, Amphotericin B in Intralipid (6 trials, 379 patients), Amphotericin B colloidal dispersion (ABCD) (2 trials, 262 patients), and Amphotericin B lipid complex (ABLC) (1 trial, 105 patients) all decreased the occurrence of nephrotoxicity, but conventional Amphotericin B was rarely administered under optimal circumstances. For the 2011 update no additional trials were identified for inclusion. Authors’ conclusions It is not clear whether there are any advantages of lipid-based formulations if conventional Amphotericin B is administered under optimal circumstances and their high cost prohibits routine use in most settings. There is a need for large trials comparing lipid-based formulations of Amphotericin B with conventional Amphotericin B given in the same dose, with routine premedication for prevention of infusion-related toxicity, and with supplementation with fluid, potassium and magnesium for prevention of nephrotoxicity.

  • Amphotericin B lipid soluble formulations vs Amphotericin B in cancer patients with neutropenia.
    The Cochrane database of systematic reviews, 2000
    Co-Authors: H K Johansen, P C Gotzsche
    Abstract:

    Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. To compare the effect and adverse effects of AmBisome and other lipid soluble formulations of Amphotericin B with conventional Amphotericin B in cancer patients with neutropenia. MEDLINE and Cochrane Library. Unpublished trials from conference proceedings and contact to industry. Randomised trials comparing lipid soluble formulations of Amphotericin B with conventional Amphotericin B. Data on mortality, invasive fungal infection, nephrotoxicity, serum creatinine and dropouts were extracted by both authors independently. AmBisome vs conventional Amphotericin B (3 trials, 1149 patients): AmBisome tended to be more effective than conventional Amphotericin B for invasive fungal infection (relative risk 0.63, 95% confidence interval 0.39 to 1.01, P=0.053) whereas there was no significant difference in mortality (relative risk 0.74, 95% CI 0.52 to 1.07). AmBisome decreased significantly the incidence of nephrotoxicity, defined as a 100% increase in serum creatinine (relative risk 0.51, 95% CI 0.40 to 0.64). Fewer patients dropped out on AmBisome but the difference was not significant (relative risk 0.78, 95% CI 0.56 to 1. 08). Amphotericin B in Intralipid vs conventional Amphotericin B (4 trials, 145 patients): There were no significant differences in clinical effect whereas the patients treated with the lipid soluble formulation experienced significantly less nephrotoxicity (relative risk 0.34, 95% CI 0.15 to 0.75) and smaller increases in serum creatinine (weighted mean difference 32 micromol/l, 95% CI 21 to 43 micromol/l). Amphotericin B colloidal dispersion (ABCD) vs conventional Amphotericin B (1 trial, 213 patients): There was lower nephrotoxicity with ABCD (relative risk 0.38, 95% CI 0.25 to 0.59). AmBisome is a better drug than conventional Amphotericin B but its high cost prohibits routine use in most settings. Furthermore, the advantages of AmBisome may be smaller than indicated in our review if conventional Amphotericin B is administered under optimal circumstances. It is not clear whether other lipid formulations of Amphotericin B could offer a worthwhile advantage compared to conventional Amphotericin B.

Rachel A Pendleton – One of the best experts on this subject based on the ideXlab platform.

  • systemic absorption of Amphotericin b with topical 5 mafenide acetate Amphotericin b solution for grafted burn wounds is it clinically relevant
    Burns, 2010
    Co-Authors: Rachel A Pendleton, James H. Holmes
    Abstract:

    Abstract Objective To determine if patients receiving topical Amphotericin B in combination with 5% mafenide acetate solution will acquire systemically detectable levels of Amphotericin B. Methods A prospective, observational study of consecutive patients from May 2007 to March 2008 who received 5% mafenide acetate/Amphotericin B (2 mcg/ml) solution topically every 4 h to their excised and grafted burn wounds for at least 5 days. Serum Amphotericin B levels were measured every 5 days during treatment. In addition, the percentage of graft take, occurrence of infection, and potential adverse reactions or toxicities were monitored and recorded. Results A total of 27 patients were enrolled, accumulating 420 treatment days and 72 Amphotericin B levels. Sixty-nine of the Amphotericin B levels were undetectable, while 3 were detectable at non-therapeutic levels ( Conclusions We conclude that 5% mafenide acetate/Amphotericin B (2 mcg/ml) solution, applied to excised and grafted burn wounds, does not produce clinically relevant serum levels of Amphotericin B. Based on our observations, this topical regimen is safe.

  • Systemic absorption of Amphotericin B with topical 5% mafenide acetate/Amphotericin B solution for grafted burn wounds: Is it clinically relevant?
    Burns, 2009
    Co-Authors: Rachel A Pendleton, James H. Holmes
    Abstract:

    Abstract Objective To determine if patients receiving topical Amphotericin B in combination with 5% mafenide acetate solution will acquire systemically detectable levels of Amphotericin B. Methods A prospective, observational study of consecutive patients from May 2007 to March 2008 who received 5% mafenide acetate/Amphotericin B (2 mcg/ml) solution topically every 4 h to their excised and grafted burn wounds for at least 5 days. Serum Amphotericin B levels were measured every 5 days during treatment. In addition, the percentage of graft take, occurrence of infection, and potential adverse reactions or toxicities were monitored and recorded. Results A total of 27 patients were enrolled, accumulating 420 treatment days and 72 Amphotericin B levels. Sixty-nine of the Amphotericin B levels were undetectable, while 3 were detectable at non-therapeutic levels ( Conclusions We conclude that 5% mafenide acetate/Amphotericin B (2 mcg/ml) solution, applied to excised and grafted burn wounds, does not produce clinically relevant serum levels of Amphotericin B. Based on our observations, this topical regimen is safe.

H K Johansen – One of the best experts on this subject based on the ideXlab platform.

  • Amphotericin b lipid soluble formulations versus Amphotericin b in cancer patients with neutropenia
    Cochrane Database of Systematic Reviews, 2014
    Co-Authors: H K Johansen, P C Gotzsche
    Abstract:

    Background Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. Objectives To compare the benefits and harms of lipid soluble formulations of Amphotericin B with conventional Amphotericin B in cancer patients with neutropenia. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 4, 2007, PubMed (November 2007) and the reference lists of articles. We searched the proceedings of the ICAAC (from 1990 to 2007), General Meeting of the ASM (from 1990 to 2007), and the European Congress of Clinical Microbiology and Infectious Diseases (1995 to 2007) and contacted researchers in the field. For the 2011 update we searched PubMed from 1966 to 18 July 2011 and the reference lists of articles. Selection criteria Randomised clinical trials comparing lipid soluble formulations of Amphotericin B with conventional Amphotericin B. Data collection and analysis The two review authors independently assessed trial eligibility, risk of bias and abstracted data. Main results We found 12 trials (1895 patients). Lipid-based Amphotericin B was not more effective than conventional Amphotericin B for mortality (relative risk (RR) 0.83, 95% confidence interval (CI) 0.62 to 1.12), but decreased invasive fungal infection (RR 0.65, 95% CI 0.44 to 0.97), nephrotoxicity, defined as a 100% increase in serum creatinine (RR 0.45, 95%CI 0.37 to 0.54), and number of dropouts (RR 0.78, 95%CI 0.62 to 0.97). For the drug used in most patients, AmBisome (3 trials, 1149 patients), there was no significant difference in mortality (RR 0.74, 95% CI 0.52 to 1.07) whereas it tended to be more effective than conventional Amphotericin B for invasive fungal infection (RR 0.63, 95% CI 0.39 to 1.01, P = 0.053). AmBisome, Amphotericin B in Intralipid (6 trials, 379 patients), Amphotericin B colloidal dispersion (ABCD) (2 trials, 262 patients), and Amphotericin B lipid complex (ABLC) (1 trial, 105 patients) all decreased the occurrence of nephrotoxicity, but conventional Amphotericin B was rarely administered under optimal circumstances. For the 2011 update no additional trials were identified for inclusion. Authors’ conclusions It is not clear whether there are any advantages of lipid-based formulations if conventional Amphotericin B is administered under optimal circumstances and their high cost prohibits routine use in most settings. There is a need for large trials comparing lipid-based formulations of Amphotericin B with conventional Amphotericin B given in the same dose, with routine premedication for prevention of infusion-related toxicity, and with supplementation with fluid, potassium and magnesium for prevention of nephrotoxicity.

  • The Cochrane Library – Amphotericin B lipid soluble formulations versus Amphotericin B in cancer patients with neutropenia
    The Cochrane database of systematic reviews, 2014
    Co-Authors: H K Johansen, P C Gotzsche
    Abstract:

    Background Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. Objectives To compare the benefits and harms of lipid soluble formulations of Amphotericin B with conventional Amphotericin B in cancer patients with neutropenia. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 4, 2007, PubMed (November 2007) and the reference lists of articles. We searched the proceedings of the ICAAC (from 1990 to 2007), General Meeting of the ASM (from 1990 to 2007), and the European Congress of Clinical Microbiology and Infectious Diseases (1995 to 2007) and contacted researchers in the field. For the 2011 update we searched PubMed from 1966 to 18 July 2011 and the reference lists of articles. Selection criteria Randomised clinical trials comparing lipid soluble formulations of Amphotericin B with conventional Amphotericin B. Data collection and analysis The two review authors independently assessed trial eligibility, risk of bias and abstracted data. Main results We found 12 trials (1895 patients). Lipid-based Amphotericin B was not more effective than conventional Amphotericin B for mortality (relative risk (RR) 0.83, 95% confidence interval (CI) 0.62 to 1.12), but decreased invasive fungal infection (RR 0.65, 95% CI 0.44 to 0.97), nephrotoxicity, defined as a 100% increase in serum creatinine (RR 0.45, 95%CI 0.37 to 0.54), and number of dropouts (RR 0.78, 95%CI 0.62 to 0.97). For the drug used in most patients, AmBisome (3 trials, 1149 patients), there was no significant difference in mortality (RR 0.74, 95% CI 0.52 to 1.07) whereas it tended to be more effective than conventional Amphotericin B for invasive fungal infection (RR 0.63, 95% CI 0.39 to 1.01, P = 0.053). AmBisome, Amphotericin B in Intralipid (6 trials, 379 patients), Amphotericin B colloidal dispersion (ABCD) (2 trials, 262 patients), and Amphotericin B lipid complex (ABLC) (1 trial, 105 patients) all decreased the occurrence of nephrotoxicity, but conventional Amphotericin B was rarely administered under optimal circumstances. For the 2011 update no additional trials were identified for inclusion. Authors’ conclusions It is not clear whether there are any advantages of lipid-based formulations if conventional Amphotericin B is administered under optimal circumstances and their high cost prohibits routine use in most settings. There is a need for large trials comparing lipid-based formulations of Amphotericin B with conventional Amphotericin B given in the same dose, with routine premedication for prevention of infusion-related toxicity, and with supplementation with fluid, potassium and magnesium for prevention of nephrotoxicity.

  • Amphotericin B lipid soluble formulations vs Amphotericin B in cancer patients with neutropenia.
    The Cochrane database of systematic reviews, 2000
    Co-Authors: H K Johansen, P C Gotzsche
    Abstract:

    Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. To compare the effect and adverse effects of AmBisome and other lipid soluble formulations of Amphotericin B with conventional Amphotericin B in cancer patients with neutropenia. MEDLINE and Cochrane Library. Unpublished trials from conference proceedings and contact to industry. Randomised trials comparing lipid soluble formulations of Amphotericin B with conventional Amphotericin B. Data on mortality, invasive fungal infection, nephrotoxicity, serum creatinine and dropouts were extracted by both authors independently. AmBisome vs conventional Amphotericin B (3 trials, 1149 patients): AmBisome tended to be more effective than conventional Amphotericin B for invasive fungal infection (relative risk 0.63, 95% confidence interval 0.39 to 1.01, P=0.053) whereas there was no significant difference in mortality (relative risk 0.74, 95% CI 0.52 to 1.07). AmBisome decreased significantly the incidence of nephrotoxicity, defined as a 100% increase in serum creatinine (relative risk 0.51, 95% CI 0.40 to 0.64). Fewer patients dropped out on AmBisome but the difference was not significant (relative risk 0.78, 95% CI 0.56 to 1. 08). Amphotericin B in Intralipid vs conventional Amphotericin B (4 trials, 145 patients): There were no significant differences in clinical effect whereas the patients treated with the lipid soluble formulation experienced significantly less nephrotoxicity (relative risk 0.34, 95% CI 0.15 to 0.75) and smaller increases in serum creatinine (weighted mean difference 32 micromol/l, 95% CI 21 to 43 micromol/l). Amphotericin B colloidal dispersion (ABCD) vs conventional Amphotericin B (1 trial, 213 patients): There was lower nephrotoxicity with ABCD (relative risk 0.38, 95% CI 0.25 to 0.59). AmBisome is a better drug than conventional Amphotericin B but its high cost prohibits routine use in most settings. Furthermore, the advantages of AmBisome may be smaller than indicated in our review if conventional Amphotericin B is administered under optimal circumstances. It is not clear whether other lipid formulations of Amphotericin B could offer a worthwhile advantage compared to conventional Amphotericin B.

A Datry – One of the best experts on this subject based on the ideXlab platform.

  • in vitro susceptibility testing of candida and aspergillus spp to voriconazole and other antifungal agents using etest results of a french multicentre study
    International Journal of Antimicrobial Agents, 2005
    Co-Authors: M Mallie, J M Bastide, A Blancard, Alain Bonnin, Stephane Bretagne, M Cambon, Jacques Chandenier, V Chauveau, B Couprie, A Datry
    Abstract:

    Minimum inhibitory concentrations (MICs) of the antifungal agent voriconazole were determined using the Etest® and compared with those of Amphotericin B, itraconazole and fluconazole using 1986 clinical isolates of Candida spp. Voriconazole MICs were also compared with those of Amphotericin B and itraconazole using 391 clinical isolates of Aspergillus spp. Voriconazole was found to have more potent activity and lower MIC values than Amphotericin B, itraconazole and fluconazole against C. albicans, C. tropicalis, C. parapsilosis and C. kefyr. Against C. glabrata and C. krusei, voriconazole was more active than either of the other two azole antifungals but had similar activity to Amphotericin B. For species of Aspergillus, MIC values of voriconazole were lower than those of Amphotericin B and itraconazole against A. fumigatus and A. flavus, and were similar to those of Amphotericin B against A. niger. Against A. terreus, MIC values for voriconazole and itraconazole were similar. A. terreus is known to be resistant to Amphotericin B, and this was reflected in higher MIC values compared with those of voriconazole and itraconazole. Voriconazole therefore compares very favourably with other antifungal agents against a large number of clinical isolates of Candida and Aspergillus spp.

  • In vitro susceptibility testing of Candida and Aspergillus spp. to voriconazole and other antifungal agents using Etest ® : results of a French multicentre study
    International Journal of Antimicrobial Agents, 2005
    Co-Authors: M Mallie, J M Bastide, A Blancard, Alain Bonnin, Stephane Bretagne, M Cambon, Jacques Chandenier, V Chauveau, B Couprie, A Datry
    Abstract:

    Minimum inhibitory concentrations (MICs) of the antifungal agent voriconazole were determined using the Etest(R) and compared with those of Amphotericin B. itraconazole and fluconazole using 1986 clinical isolates of Candida spp. Voriconazole MICs were also compared with those of Amphotericin B and itraconazole using 391 clinical isolates of Aspergillus spp. Voriconazole was found to have more potent activity and lower MIC values than Amphotericin B, itraconazole and fluconazole against C. albicans, C. tropicalis, C. parapsilosis and C. kefyr. Against C. glabrata and C. krusei, voriconazole was more active than either of the other two azole antifungals but had similar activity to Amphotericin B. For species of Aspergillus, MIC values of voriconazole were lower than those of Amphotericin B and itraconazole against A. fumigatus and A. flavus, and were similar to those of Amphotericin B against A. niger. Against A. terreus, MIC values for voriconazole and itraconazole were similar. A. terreus is known to be resistant to Amphotericin B, and this was reflected in higher MIC values compared with those of voriconazole and itraconazole. Voriconazole therefore compares very favourably with other antifungal agents against a large number of clinical isolates of Candida and Aspergillus spp.