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Biomedical subjects

M Karthaus

Publications and source records attributed to M Karthaus.

At least 19 recordsLinked to original sources
PubMed2005

Dalteparin for prevention of catheter-related complications in cancer patients with central venous catheters: final results of a double-blind, placebo-controlled phase III trial.

BACKGROUND: Cancer patients receiving chemotherapy experience thromboembolic complications associated with the use of long-term indwelling central venous catheters (CVCs). This prospective, double-blind, placebo-controlled, multicenter study evaluated whether prophylactic treatment with a low molecular weight heparin could prevent clinically relevant catheter-related thrombosis. PATIENTS AND METHODS: Patients with cancer undergoing chemotherapy for at least 12 weeks (n=439) were randomly assigned, in a 2:1 ratio, to receive either dalteparin (5000 IU) or placebo, by subcutaneous injection, once daily for 16 weeks. Patients underwent upper extremity evaluation with either venography or ultrasound at the time of a suspected catheter-related complication (CRC) or upon completion of study medication. The primary end point, as determined by a blinded adjudication committee, was the occurrence of a CRC, defined as the first occurrence of any one of the following: clinically relevant catheter-related thrombosis that was symptomatic or that required anticoagulant or fibrinolytic therapy; catheter-related clinically relevant pulmonary embolism; or catheter obstruction requiring catheter removal. RESULTS: There was no significant difference in the frequency of CRCs between the dalteparin arm (3.7%) and the placebo arm (3.4%; P=0.88), corresponding to a relative risk of 1.0883 (95% confidence interval 0.37-3.19). No difference in the time to CRC was observed between the two arms (P=0.83). There was no significant difference between the dalteparin and placebo groups in terms of major bleeding (1 versus 0) or overall safety. CONCLUSIONS: Dalteparin prophylaxis did not reduce the frequency of thromboembolic complications after CVC implantation in cancer patients. Dalteparin was demonstrated to be safe over 16 weeks of treatment in these patients.

Anticoagulants↗
PubMed2005

Prospective, double-blind, placebo-controlled, multicenter, randomized phase III study with orally administered budesonide for prevention of irinotecan (CPT-11)-induced diarrhea in patients with advanced colorectal cancer.

BACKGROUND: Unpredictable and severe diarrhea (NCI grade > or =3) remains a life-threatening adverse event in patients treated with irinotecan (CPT-11). The aim of this study was to evaluate the efficacy and safety of orally administered budesonide for prevention of CPT-11-induced delayed diarrhea in patients with advanced colorectal cancer. PATIENTS AND METHODS: A total of 56 patients with advanced colorectal cancer receiving CPT-11 therapy (125 mg/m2 once weekly) were enrolled in this multicenter trial. Patients were randomly treated with 3 mg budesonide orally 3 times daily versus placebo. Detailed assessment of diarrhea by monitoring stool frequency, stool consistency and loperamide rescue medication was made by keeping a diary. RESULTS: Diarrhea, defined as number of stools >4 occurring on a single day during the study period, could be prevented in 58.3% of the budesonide-treated patients compared to 38.5% of the patients under placebo. Patients in the budesonide group had less episodes (0.7 vs. 2.2 episodes) and a considerably shorter total duration of diarrhea (1.8 vs. 4.2 days) episodes than patients in the placebo group. Loperamide use was more frequent in the placebo than in the budesonide arm (55.6 vs. 41.7%). Also, exposure to rescue medication of loperamide was higher for placebo (36.2 capsules) than for budesonide (24.9 capsules). A superior prevention of diarrhea was observed for budesonide compared to placebo in the first cycle (14 vs. 10; p = 0.257), with more failures observed in the placebo group (16 vs. 10). CONCLUSION: This double-blind randomized trial failed to show that budesonide has a significant benefit in preventing CPT-11-induced diarrhea. While a trend exists, further trials are warranted.

Administration, Oral↗
PubMed2004

Reduction of catheter-related infections in neutropenic patients: a prospective controlled randomized trial using a chlorhexidine and silver sulfadiazine-impregnated central venous catheter.

Antiseptic coating of intravascular catheters may be an effective means of decreasing catheter-related colonization and subsequent infection. The purpose of this study was to assess the efficacy of chlorhexidine and silver sulfadiazine (CH-SS)-impregnated central venous catheters (CVCs) to prevent catheter-related colonization and infection in patients with hematological malignancies who were subjected to intensive chemotherapy and suffered from severe and sustained neutropenia. Proven CVC-related bloodstream infection (BSI) was defined as the isolation of the same species from peripheral blood culture and CVC tip (Maki technique). This randomized, prospective clinical trial was carried out in 106 patients and compared catheter-related colonization and BSI using a CH-SS-impregnated CVC (n=51) to a control arm using a standard uncoated triple-lumen CVC (n=55). Patients were treated for acute leukemia (n=89), non-Hodgkin's lymphoma (n=10), and multiple myeloma (n=7). Study groups were balanced regarding to age, sex, underlying diseases, insertion site, and duration of neutropenia. The CVCs were in situ a mean of 14.3+/-8.2 days (mean+/-SD) in the study group versus 16.6+/-9.7 days in the control arm. Catheter-related colonization was observed less frequently in the study group (five vs nine patients; p=0.035). CVC-related BSI were significantly less frequent in the study group (one vs eight patients; p=0.02). In summary, in patients with severe neutropenia, CH-SS-impregnated CVCs yield a significant antibacterial effect resulting in a significantly lower rate of catheter-related colonization as well as CVC-related BSI.

Bacteremia↗
PubMed2003

Combination therapy of disseminated Fusarium oxysporum infection with terbinafine and amphotericin B.

A case of disseminated infection with Fusarium oxysporum following chemotherapy of acute myelogenous leukemia is reported. Antifungal treatment was successful with a 13-day course of oral terbinafine 250 mg t.i.d. in combination with amphotericin B deoxycholate 1.0-1.5 mg/kg qd and subsequently intravenous liposomal amphotericin B 5 mg/kg qd. Preceding monotherapy with amphotericin B deoxycholate 1.0-1.5 mg/kg qd had not stopped the progression of infection. The combination therapy described here represents a novel approach to the treatment of Fusarium spp. in the immunocompromised host in whom Fusarium spp. are known to cause disseminated infection with high mortality.

Amphotericin B↗
PubMed2003

Diagnosis of invasive fungal infections in hematology and oncology--guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO).

Invasive fungal infections are a primary cause of morbidity and mortality in patients with hematological malignancies. Establishing a definite diagnosis of invasive fungal infection in febrile neutropenic patients is particularly challenging and time-consuming, but a delay of antifungal treatment leads to higher mortality. This situation has lead to the strategy of initiation "empirical" antifungal therapy prior to the detection of fungi. Meanwhile, improvements in diagnostic procedures are achieved, especially with imaging techniques and non-culture based methods which include antigen-based assays, metabolite detection and molecular detection of fungal DNA from body fluid samples using conserved or specific genome sequences. The AGIHO presents recommendations for the diagnosis of invasive fungal infections with risk-adapted screening concepts for the neutropenic and febrile episodes of patients with hemato-oncological disorders.

Hematology↗
PubMed2003

Use of erythropoietin in patients with multiple myeloma.

The prevalence of tumour anaemia in patients with multiple myeloma is greater than 80%. At the time of diagnosis 20% of these patients are already anaemic. In about 70% of patients with multiple myeloma, recombinant human erythropoietin (r-HuEPO) leads to a reduction in transfusion frequency, resulting in a drop in transfusion- related side-effects like infections and immune reactions, iron overload and hyperviscosity which often negatively influence the course of disease. A further reason for the use of erythropoietin is to achieve and maintain high haemoglobin levels (11-12 g/dl), which are of considerable prognostic significance in patients with multiple myeloma. Increasing Hb levels with r-HuEPO also improve the quality of life of patients, thus leading to better therapy compliance. The trade-off between high costs of an erythropoietin treatment and lower indirect costs (infusion material, personal equipment, patient transport costs, etc.) should be evaluated. Nevertheless, an exact definition of patients for whom the use of erythropoietin is beneficial is warranted. The pathogenesis of anaemia and the clinical experiences of erythropoietin in patients with multiple myeloma are discussed.

Anemia↗
PubMed2003

Ceftriaxone in febrile neutropenia.

Standard management of febrile neutropenia requires prompt administration of empirical, broad-spectrum antibiotic therapy, since febrile neutropenia is associated with a significant risk of infectious complications and mortality. Risk-assessment models have been developed that differentiate febrile patients with neutropenia according to their risk for infectious complications and/or mortality and have prompted a change in the management of these patients. Ceftriaxone is a long-lasting, broad spectrum cephalosporin which has demonstrated efficacy in this indication in many publications. The role of ceftriaxone in febrile neutropenia will be discussed based on literature analysis and on the author's experience.

Anti-Bacterial Agents↗
PubMed2002

Treatment of severe Candida infections in high-risk patients in Germany: consensus formed by a panel of interdisciplinary investigators.

Now that modern medicine can provide increasing chances of cure to patients with formerly incurable disorders, therapy-related complications play the key role in outcome. Thus, among opportunistic infections, severe candidiasis remains a challenge. A multidisciplinary panel of 20 investigators was formed to find a consensus on antifungal strategies for various underlying conditions in neutropenic and non-neutropenic patients. To record their preferences, the investigators used an anonymous voting system. Among antifungal agents, fluconazole emerged as the major alternative to the classic amphotericin B, being therapeutically at least equivalent but clearly less toxic. Factors that restrict the use of fluconazole include pretreatment with azoles, involvement of resistant species like Candida krusei, and an inability to exclude aspergillosis. Flucytosine can be reasonably combined with both amphotericin B and fluconazole. Within the limited antifungal armamentarium, amphotericin B lipid formulations and itraconazole also appear useful and require further investigation. The general consensus of the group is that antifungal agents should be administered at sufficient dosages, rather early, and often empirically.

Antifungal Agents↗
PubMed2002

Central venous catheter infections in patients with acute leukemia.

BACKGROUND: Central venous catheters (CVCs) have become an essential tool for an appropriate management of patients with acute leukemia. Infectious complications are a major concern in patients treated for acute leukemia. Although CVC-related infections are considered to be a major source of infections during neutropenia (<500/microl), data regarding the incidence of CVC-related infections are rare in acute leukemia. PATIENTS AND METHODS: We analyzed nontunneled CVCs in 58 patients with acute leukemia (22 men/36 women) in 119 chemotherapy cycles from April 1996 to January 1998 in a prospective trial. Proven CVC-related infection was defined as the isolation of the same organism from peripheral blood and CVC tip. CVC infection was suspected or possible when exit site inflammation and positive blood culture or organisms typical for CVC infection were observed. RESULTS: Mean neutropenia/cycle was 16.3 days (SD 8.0). 178 CVCs with 2,576 CVC days (mean 14.5 days, SD 7.2 days) were used in 119 cycles. Fever occurred in 87 cycles (73%). Blood stream infection was proven in 31 out of 87 febrile episodes (26.1%) with 40 isolates (8 gram-negative, 31 gram-positive, 1 Candida spp.). Colonization of the CVC tip was observed in 24 CVC lines with 28 isolates (27 gram-positive, 1 gram-negative); however, proven CVC-related infections were observed in 5 episodes only, all with coagulase-negative staphylococci. In another 6 episodes, CVC-related infection was assumed (local inflammation and gram-positive blood culture). Six further episodes had typical blood isolates (4 coagulase-negative staphylococci, 1 Candida spp.) and were considered possible CVC-related infections. In none of the remaining afebrile 32 cycles was a CVC infection observed or suspected. CONCLUSION: Gram-positive organisms contributed to the majority of CVC-related infections (16 out 17 CVC infections); however, the overall incidence of CVC infections in acute leukemia patients was 6.5/1,000 CVC days only (1.9 proven/2.3 suspected/2.3 possible/1,000 CVC days).

Adult↗
PubMed2001

Slow-release tramadol for treatment of chronic malignant pain--an open multicenter trial.

Patients with moderate to severe cancer pain and insufficient pain relief from nonopioid analgesics were treated with slow-release tramadol for initial dose finding and as a long-term treatment. Immediate-release tramadol was provided for the treatment of breakthrough pain and a standard nonopioid analgesic (1000 mg naproxen daily) was given as suggested for step 2 of the WHO analgesic ladder. Ninety of 146 patients (62%) completed the 6-week trial period. Drop-outs were due to adverse events (20%), inadequate pain relief (9%), or both (2.5%), death due to the underlying disease (4%), low patient compliance (2%) or other reasons. Average and maximal pain intensity decreased from day 1 to day 4. The number of patients with good and complete pain relief increased from 43% after week 1 to 71% after week 6 with maximum daily doses of tramadol up to 650 mg. However, 70% of the patients still needed less than 400 mg tramadol per day in week 6. Most patients (86%) experienced adverse events during the study period. Some common side effects of opioids, such as fatigue, dizziness, and constipation, decreased in frequency over the 6 weeks. The frequency of other adverse events such as nausea, vomiting and sweating did not change. Slow-release tramadol provided fast and efficient pain relief in almost two-thirds of patients both during initial dose finding and during long-term treatment, improving treatment options in step 2 of the WHO analgesic ladder.

Adult↗
PubMed2001

[Cytostatic drug extravasation--are there new recommendations for therapeutic management?].

Extravasations are a matter of concern in cytostatic treatment. They may range from patients' discomfort up to severe complications such as necrosis and amputation. Cytotoxic drugs in general differ in a broad variety in their ability to induce severe cutaneous reactions and therefore the possible counter-measures vary. Though the compliance with regulations concerning the application and injection or infusion of cytotoxic substances can minimize the risk of inducing an extravasation, these basic safety procedures are reflected beside an overview of the literature concerning specific antidotes and procedures.

Antineoplastic Agents↗
PubMed2001

[Changes in the epidemiology of infections in patients with febrile neutropenia].

Over the last years, advances in the treatment and supportive care of patients with cancer have led to substantial improvement in long-term survival. Nevertheless, bacterial infection continues to contribute significantly to illness and death in patients developing chemotherapy-induced neutropenia. In this severely ill population, the early administration of appropriate empirical antibiotic therapy for febrile episodes is crucial. This therapeutic approach has been shown to decrease morbidity and mortality due to infections caused by gram negative bacilli. However, in recent years, gram positive pathogens have been recovered at a notably increased rate from neutropenic patients with cancer. Although mortality associated to gram positive bacteremia is commonly lower than that caused by gram negative bacilli, an increasing frequency of serious complications of bacteremia due to viridans group streptococci has been observed in some institutions. Moreover, the emerging problems of bacterial resistance to various antimicrobial agents is of great concern. Herein, we examine major changes in the epidemiology of bacterial infections in neutropenic patients with cancer and some clinical aspects of infections caused by most frequent pathogens.

Anti-Bacterial Agents↗
PubMed2001

[Current approaches in prevention and therapy of chemo- and radiotherapy-induced oral mucositis].

Oral mucositis is a major, often dose-limiting toxicity in modern cancer-therapy, leading to dose reductions or delay in further cancer treatment. It predisposes to life-threatening septic complication during aplasia and substantially reduces quality of life for cancer patients. At present the basic strategies in oral mucositis aim at pain relief and prevention of infectious complications. However, no effective causal prophylaxis or treatment of oral mucositis is widely accepted. The introduction of cytokines, e.g. granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF), the use of cytoprotective agents, e.g. amifostine and the stimulation of basal-cell proliferation by soft-laser irradiation or silver nitrate offer new and hopeful approaches in oral mucositis. Large-scale clinical trials to confirm effectiveness and optimize treatment schedules have to be done.

Antineoplastic Agents↗
PubMed2001

[Antimicrobial therapy of febrile neutropenia--current developments].

Standard management of febrile neutropenia requires prompt administration of empirical, broad-spectrum, parenteral antibiotic therapy, since febrile neutropenia is associated with a significant risk of infectious complications and mortality. Although in-patient treatment is effective in up to 90%, hospitalization leads to excessive resource utilization. Over the last ten years chemotherapy for solid tumors has shifted out of the hospital setting into the ambit of community-based oncologists, and outpatient treatment with complex multidrug protocols has become more and more common. With the increase in the numbers of outpatients undergoing multidrug chemotherapy there has been a corresponding rise in the severity and duration of neutropenia and in the increase of febrile complications. Risk-assessment models have been developed that differentiate febrile patients with neutropenia according to their risk for infectious complications and/or mortality. Patients with neutropenia of short duration (< 7 days) and fever are at relatively low risk for complications if they have no concurrent comorbidities, and in these circumstances outpatient antibiotic treatment is an alternative to costly hospitalization. Drugs whose antimicrobial coverage and pharmacokinetics render them particularly suitable for outpatient treatment of febrile neutropenia include intravenous and oral quinolones and, for once-daily dosing, intravenous glycopeptides, ceftriaxone and intravenous aminoglycosides. Response rates of 60%-95% have been achieved with such regimens in clinical trials, with hospital admission avoided in 75%-95% of cases.

Ambulatory Care↗