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At least 595 records · Page 33Linked to original sources
PubMed1994

A multicentre study: Staphylococcus and Enterococcus susceptibility to antibiotics.

A multicentre study to evaluate the susceptibility of Gram-positive cocci isolated from clinical samples, was performed by six centres working in different areas of Italy. We examined 4,544 strains of Staphylococcus aureus, 4,381 strains of coagulase-negative staphylococci and 2,478 strains of enterococci. The following antibiotics were tested: penicillin G, ampicillin, amoxicillin, piperacillin, imipenem, oxacillin, ofloxacin, pefloxacin, ciprofloxacin, gentamicin, tobramycin, amikacin, netilmicin, rifampicin, clindamycin, tetracycline, cotrimoxazole, erythromycin, chloramphenicol, vancomycin and teicoplanin. Oxacillin-susceptible staphylococci confirmed their susceptibility to many other antimicrobial agents while oxacillin-resistant strains confirmed their multiple and frequent resistance to antibiotics. Resistance to oxacillin, cotrimoxazole and chloramphenicol was more frequent in coagulase-negative staphylococci than in Staphylococcus aureus. Aminoglycosides, rifampicin and quinolones were more active against coagulase-negative staphylococci than against Staphylococcus aureus. Enterococci were susceptible to penicillins and imipenem, and moderately susceptible to ciprofloxacin. Susceptibility of 70-79% was observed with high levels of aminoglycosides. Excellent results against staphylococci and enterococci were observed with vancomycin and teicoplanin.

Anti-Bacterial Agents↗
PubMed1989

A prospective multicentre study of in-patient treatment for alcoholics: 18- and 48-month follow-up (Munich Evaluation for Alcoholism Treatment, MEAT).

In a prospective multicentre study of 1410 alcoholics (73% men) data were collected at five different times: admission, discharge, 6, 18 and 48 months after discharge. The details from the 21 treatment centres involved were acquired from staff-members; follow-up data on patients were collected by personal interviews and/or mailed questionnaires. In all, 85%, 84% and 81% of the patients could be traced, respectively. Additionally, data of patients' sick leave days and in-patient treatment were provided by the health insurance and pension insurance institutions, respectively. Outcome criteria were drinking behaviour, working and partner situation, and subjective complaints. The drinking behaviour was divided into three rough categories: abstinent, improved and unimproved. For 18 months 53% of the patients remained abstinent, 8.5% improved and 38% did not improve. For 48 months 46% remained abstinent, 12% improved and 42% did not improve. During the last 6 months prior to the 48-month data collection 66% were abstinent, 4% improved and 30% did not improve. Only 3% of patients succeeded in maintaining controlled drinking. The percentage of days of sick leave was reduced by 64% and of in-patient treatment from 34.7% to 14.6% during the 18-month period after discharge (in comparison with the 18-month period prior to treatment). Only 21% of the patients regularly attended self-help groups. Out of the patients' variables, ten for men and five for women could be identified as prognostically relevant. In the 48-month follow-up these factors were reconsidered. In men almost all, in women only three of the five factors were confirmed. The treatment variables were evaluated according to the prognosis factors (positive vs negative group). In the 48-month follow-up the treatment variables relevant in the 18-month follow-up were also reassessed. In the positive prognosis group five variables were confirmed, in the negative prognosis group only one. In addition, differentiated indication variables for the three treatment lengths were developed and applied to a model. The following appeared to be clues regarding the length of desirable treatment. For an unfavourable prognosis in both men and women no short-term treatment should be given; medium- or long-term treatment is to be preferred. For a medium prognosis men do better with short-term treatment; for women medium-treatment is preferred. For a favourable prognosis for men medium-term treatment should be avoided; long-term is preferred; for women short-term treatment may also be preferred.

Adolescent↗
PubMedDate not supplied

A multicentre, randomized comparative study of 500 mg versus 1,000 mg ceftazidime t.d.s. for treatment on gram-negative infections.

A multicentre, randomized study was performed to compare the clinical and bacteriological efficacy of 500 mg ceftazidime i.v. t.d.s. with 1,000 mg ceftazidime i.v. t.d.s. for treatment of hospitalised, non-compromised patients with gram-negative infections. The study was conducted in ten hospitals in The Netherlands. Hospitalised patients with a suspected gram-negative lower respiratory tract infection, complicated urinary tract infection or septicaemia were included. Excluded were patients with neutropenia, limited life expectancy, or severe renal insufficiency as well as those on antibiotics in the 48 h prior to entry. Ceftazidime was administered via an intravenous infusion every 8 h. For patients with moderately impaired renal function the frequency was reduced to 12 h. Treatment was continued for as long as clinically indicated. Clinical response (cure, improvement or failure) and bacteriological response (elimination, persistence or non-evaluable) were assessed primarily by the investigator. Final assessments were made by a panel of experts without prior knowledge. In total 127 patients were randomized, 64 patients to the 500 mg group and 63 to the 1,000 mg group; 47 patients were excluded from evaluation, usually due to an incorrect diagnosis prior to randomization. Ultimately 37 patients of the 500 mg group and 43 patients of the 1,000 mg group were available for evaluation. Between these two groups of evaluable patients there were no significant differences in baseline characteristics, types of infection, isolated bacterial pathogens or treatment characteristics.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1992

Energy and nutrient intake of patients with mild-to-moderate chronic renal failure compared with healthy children: an Italian multicentre study.

Nutritional counselling is important in the management of children with chronic renal failure (CRF). In 1988, a controlled European multicentre study was started to evaluate the effects of a low-protein diet on the progression of CRF in children. To assess the energy, macro- and micronutrient intake, 4-day weighed dietary records were obtained from 50 children with low to moderate CRF (creatinine clearance 65 to 15 ml/min per 1.73 m2) and from 93 healthy children. The mean energy intake was 90%-93% of the recommended dietary allowance for Italian children in controls and 76%-88% in CRF patients. The mean protein intake was 2.1-3.1 g/kg per day in controls and 1.6-2.7 g/kg per day in CRF patients. Overall, the energy intake was 10% and the protein intake 33% lower in CRF patients than in healthy children. Children with CRF consumed less cholesterol, calcium and phosphorus than healthy children. The lower spontaneous intake of energy, protein and other nutrients should be taken into account when planning the nutrition of children with CRF.

Child↗
PubMed1990

Screening for delayed-hypersensitivity in Italian children: multicentric study by multitest skin testing.

The Multitest skin test allows the simultaneous intradermal application of seven standardized recall antigens in a reproducible manner. Response reading is based on a scoring system that distinguishes between normal and diminished delayed hypersensitivity (DH). To determine incidence and size of DH responses for each antigen in relation to age and sex in healthy Italian children, a multicentric study was performed on a representative paediatric population of 491 subjects (285 males and 296 females) aged from 4 months to 16 years. In both sexes DH reactivity as measured by score and number of positive responses increased significantly with age. The incidence of anergy was 8.8% for the whole population and decreased significantly with age in both sexes. Incidence of positive responses was highest for tetanus and diphteria toxoids, intermediate for Candida, Proteus and Streptococcus, and lowest for tuberculin and Trichophyton antigens. There was no significant difference between sexes in the incidence of positive response to each antigen.

Adolescent↗
PubMed1988

Treatment of vaginal candidiasis with a single oral dose of fluconazole. Multicentre Study Group.

A single dose of 150 mg fluconazole was used to treat 180 patients with clinical and mycological evidence of vaginal candidiasis in an open, non-comparative, multicentre trial. The clinical response to treatment was excellent, with 97% of patients cured or markedly improved after 5 to 16 days. At long-term assessment (27 to 62 days), the proportion cured was 88%. Candida was eradicated from the vagina in 93% of patients at short-term assessment and in 73% at long-term assessment. The rate of relapse, reinfection or recolonization at long-term assessment in patients who had responded at short-term assessment was 23%. The incidence of side-effects was low, and consisted mainly of mild gastrointestinal complaints. Abnormal laboratory test results occurred in 15 of 167 evaluable patients, but all were minor and of minimal clinical significance. Oral fluconazole given in a single dose of 150 mg is an effective, safe and well tolerated treatment for vaginal candidiasis.

Administration, Oral↗
PubMed1992

German multicentre study on the in vitro susceptibility of Bacteroides species. The German Bacteroides Study Group.

In 1990 the first German multicentre study on the in vitro susceptibility of Bacteroides species was completed. Employing a commercially prepared microbroth dilution assay, nine participating institutions evaluated approximately 100 consecutive isolates of Bacteroides species from relevant clinical specimens. A total of 911 strains (449 Bacteroides fragilis, 201 Bacteroides thetaiotaomicron, 79 Bacteroides ovatus, 78 Bacteroides vulgatus, 77 Bacteroides distasonis, 25 Bacteroides uniformis, 2 others) were tested. Most of the isolates came from surgical patients (72%); other sources included gynaecological patients (9%) and medical patients (5%). Seventy-eight percent of the anaerobes were found in mixed culture together with at least one aerobic organism (Escherichia coli 36%, streptococci 15%, or enterococci 13%), while in 22% of the cases, the anaerobes were the only bacteria grown from the specimens. The results showed that many of the strains were potent beta-lactamase producers (as judged by resistance to amoxicillin). However, all but one of the isolates demonstrated susceptibility in vitro when clavulanic acid was added to amoxicillin or ticarcillin. At the same time, 13% of the organisms were resistant to mezlocillin, 5% to cefoxitin and 4% to clindamycin. Three strains were reported resistant to imipenem and one strain to metronidazole.

Anti-Bacterial Agents↗
PubMed1994

Treatment of oropharyngeal candidiasis in HIV-infected children with oral fluconazole. Multicentre Study Group [corrected].

In an open, noncomparative, multicentre study the efficacy and safety of oral fluconazole was evaluated in the treatment of oropharyngeal candidiasis in children with HIV infection. Fifty-one children with a mean age of five years were enrolled. Oropharyngeal candidiasis was caused by Candida albicans in 28 cases (55%). Fluconazole was given in a mean dosage of 3.4 mg/kg/d (range 2 to 5.6 mg/kg/d) for a mean duration of 12 days (range 6 to 28 days). By the end of treatment, 90% of the children were clinically cured, 6% had improved and 4% failed to respond. Candida was eradicated in 82% of the patients. Clinical failure occurred only in children given 3 mg/kg/d or less. Two and four weeks after therapy, clinical cure was confirmed in 88% and 82% of the children respectively as well as eradication in 76% respectively. Six children experienced mild side effects (1 skin rash, 5 mild elevation of liver enzyme levels). The data show that fluconazole is safe and effective in treating oropharyngeal candidiasis in HIV-infected children.

AIDS-Related Opportunistic Infections↗
PubMed1994

Fluconazole versus ketoconazole in the treatment of oropharyngeal candidiasis in HIV-infected children. Multicentre Study Group.

In an open multicentre study the efficacy and safety of fluconazole versus ketoconazole were evaluated in the treatment of 46 pediatric patients with oropharyngeal candidiasis and AIDS or HIV infection. Twenty-four subjects received oral fluconazole in a dosage of 3 mg/kg/day and 22 subjects received oral ketoconazole in a dosage of 7 mg/kg/day. The treatment duration ranged from 5 to 49 days. Results showed that fluconazole and ketoconazole have comparable efficacy and safety in the treatment of oropharyngeal candidiasis in HIV-infected children. Patients treated with fluconazole had higher clinical and mycological cure rates at the end of therapy (88% and 71% respectively) than those treated with ketoconazole (81% and 57% respectively). One case of drug-related side effects (diarrhea and abdominal pain) in a patient receiving ketoconazole resulted in discontinuation of treatment. Follow-up examinations 2 and 4 weeks post-treatment showed a comparably high rate of relapse in both patient groups.

AIDS-Related Opportunistic Infections↗
PubMed1994

Efficacy and safety of fluconazole in the treatment of systemic fungal infections in pediatric patients. Multicentre Study Group.

In a non-comparative multicentre trial 51 patients aged 24 days to 17 years received treatment with intravenous or oral fluconazole for suspected systemic fungal infections. Twenty-seven patients had confirmed infections, 26 being confirmed mycologically and 1 histologically. All isolates were Candida species. Of the 43 clinically assessed patients, 30 were considered cured, 7 improved and 6 experienced failure of therapy. Of 27 patients with confirmed fungal infections, 25 were assessed mycologically and all but one were considered cured. Of the six patients experiencing clinical failure, two had a confirmed infection and only one of these experienced mycological failure. This patient had a primary diagnosis of candidemia with persistence of Candida albicans and Candida parapsilosis. All 51 patients were evaluable for safety. No treatment-related adverse events required termination of treatment. Treatment-related side effects (diarrhea, vomiting, deafness) were reported by three of 51 patients, three patients had laboratory test abnormalities possibly related to fluconazole treatment, including elevation of liver enzyme levels and of the eosinophil count. Results of this study confirm the efficacy and safety of fluconazole in the treatment of pediatric patients with severe fungal infection.

AIDS-Related Opportunistic Infections↗
PubMed1987

Multicentre evaluation of a direct coagglutination test for group A streptococci.

A coagglutination test for detection of group A streptococci in throat samples was evaluated in a multicentre study and found to be about 95% sensitive when applied to swabs taken from symptomatic patients which yielded more than 100 colonies per plate on culture. The sensitivity of the test dropped significantly when it was applied to swabs giving fewer than 100 colonies on culture. The specificity of the test was high regardless of colony count on conventional media.

Acute Disease↗
PubMed1994

A rare coexistence of a multicentric hepatic hemangioendothelioma with a large brain hemangioma in a preterm infant.

A preterm infant with a rare association of a multicentric hepatic hemangioendothelioma (MHH) and a large brain hemangioma is described. The imaging investigations and their findings are discussed. It is recommended that whole-body radionuclide imaging with 99mTc-labeled red blood cells is employed immediately following ultrasonography to confirm the suspected diagnosis of MHH and to detect other unsuspected hemangiomas.

Brain Neoplasms↗
PubMed1986

A double-blind multicentre trial of piroxicam and naproxen in osteoarthritis.

A multicentre, double-blind study of unprecedented size was conducted to compare the safety and efficacy of piroxicam and naproxen in the treatment of osteoarthritis. The study comprised 2,035 patients and a treatment period of 12 weeks. The dosage was 20 mg piroxicam and 750 mg naproxen daily with the option to reduce to 10 and 500 mg, respectively, at week 4 or 8. No major difference between the drugs was observed with regard to overall incidence of adverse events. The frequency of serious adverse events was about 1% for both drugs. A statistically significant decline of adverse events with age was found in both sexes. Piroxicam was significantly superior to naproxen for pain at rest and pain on movement at 12 weeks and degree of restriction in daily activity at 4 weeks. A significantly increasing beneficial effect was observed with both drugs between 4 and 12 weeks of treatment. The comparable safety observed for the two drugs is in contrast to perceptions based on spontaneous reports to official monitoring systems.

Aged↗
PubMed1985

Double-blind preference and compliance multicentre study in osteoarthritis: once-a-day treatment.

Two-hundred-and-three female patients (mean age: 58 yrs; SD: 8.2 yrs) suffering from osteoarthritis entered this late phase IV multicentre, stratified according to previous therapy (e.g. ketoprofen, naproxen, aspirin, indomethacin or indoprofen), randomized, double-blind, between within-patient trial of 2-week duration. Each patient received either diclofenac SR 100 mg/day (D), piroxicam 20 mg/day (P), or placebo (P1 by oral route. Clinical evaluation (functional class; pain assessment; osteoarthritic condition; joint motility and stiffness) was performed at entry, as well as after the first and the second week. Patient compliance and reported signs and symptoms were recorded after the first week and at the end of the trial. Patient preference, as regards previous therapy, and global evaluation (both by the physicians and the patients) were checked at the end of the trial. The clinical evaluation showed a superiority of D and P over P1. No difference was seen between the two active drugs. Placebo effect was very strong. Global evaluation was significantly in favour of D and P. Patient compliance was extremely good (greater than or equal to 95%). Diclofenac was preferred to naproxen, aspirin and indomethacin, while piroxicam and placebo were preferred only to aspirin. The tolerability of the two active drugs was good and comparable. A significantly lower number of patients complaining of unwanted effects (u.e.) was detected in the placebo group. The number of patients withdrawn for u.e. was similar in the three trial groups.

Adult↗
PubMed1991

The treatment of minimal change nephrotic syndrome: lessons learned from multicentre co-operative studies.

Minimal change nephrotic syndrome (MCNS) is the most frequent type of nephrotic syndrome in childhood. Treatment aims to induce remission, prevent relapses and avoid side-effects. MCNS is responsive to immunosuppressive therapy with glucocorticosteroids, alkylating drugs and cyclosporine A. From results of multicentre controlled studies it became evident that the initial treatment with prednisone should be intensive, i.e. for 12 weeks, in order to reduce the risk of subsequent relapses. Treatment of relapses should be standardized in order to categorize the patient's disease for further treatment. In case "frequent relapsers" develop signs of steroid-toxicity, they should be treated with alkylating drugs: frequent relapsers without steroid dependency with cyclophosphamide or chlorambucil for 8 weeks, steroid-dependent cases with cyclophosphamide for 12 weeks. If frequent relapses re-occur after cytotoxic drug therapy, treatment with cyclosporine A should be considered. Starting dose is 100-150 mg/m2 per day and needs to be adjusted to the whole blood trough level. Treatment with cyclosporine A must be strictly controlled in order to avoid chronic nephrotoxicity. Cyclosporine A does not cure MCNS. It is only effective as long as it is administered; therefore long-lasting treatment is necessary in most cases.

Alkylating Agents↗
PubMed1996

A clinical evaluation of flurbiprofen LAT and piroxicam gel: a multicentre study in general practice.

A prospective, randomized, multicentre, open, crossover study of the comparative efficacy, tolerability and acceptability of two topical nonsteroidal anti-inflammatory drug (NSAID) therapies, flurbiprofen local-action transcutaneous (LAT) patch (40 mg b.d.) and piroxicam gel (3 cm, 0.5% q.d.s), was conducted in general practice in the UK in 137 men and women with soft-tissue rheumatism of the shoulder or elbow (e.g. epicondylitis, tendinitis, bursitis and adhesive capsulitis). Patients received one therapy for 4 days before crossing over to the other NSAID for a further 4 days, followed by 6 days of their preferred therapy. Clinical assessment of severity of pain, tenderness and overall clinical condition was carried out at baseline and after 4, 8 and 14 days. Patients self-assessed the severity of pain during the day and at night, and also the quality of their sleep during each treatment phase. More patients showed a greater improvement in all of the clinical assessments of efficacy following treatment with flurbiprofen LAT during the crossover phase. There was a statistically significant reduction in the severity of pain, the principal measure of efficacy, in favour of flurbiprofen LAT: 42% of patients showed greater improvement with flurbiprofen LAT compared with 26% who showed a greater improvement with piroxicam gel (p = 0.012; n = 131, intent-to-treat). Eligible dataset (n = 126) analysis revealed statistically significant differences in favour of flurbiprofen LAT in the severity of lesion tenderness (p = 0.03) and the overall change in clinical condition (p = 0.04) compared with baseline status. Superior efficacy for flurbiprofen LAT was also indicated in the patients' assessment at the end of the crossover phase (day 8), at which 69% chose to continue treatment with flurbiprofen LAT compared with only 31% of patients who chose piroxicam gel (n = 126; p < 0.001). There were, in addition, statistically significant differences in favour of flurbiprofen LAT in assessments for night pain (p < 0.001), quality of sleep (p = 0.004) and the patients' overall opinion of treatment (p < 0.001). Both treatments were well tolerated with a low incidence of mainly local adverse events. These results showed that flurbiprofen LAT had a greater efficacy than piroxicam gel, and was also preferred by patients in the treatment of painful soft-tissue rheumatism of the shoulder and elbow.

Administration, Cutaneous↗
PubMed1992

A comparison of moclobemide, amitriptyline and placebo in depression: a Canadian multicentre study.

In a 7-week prospective multicentre study, the efficacy, tolerability and safety of moclobemide were compared to those of amitriptyline and placebo in parallel groups of out-patients (n = 173) fulfilling the DSM III-R criteria for a major depressive episode. Participants were required to have a minimum baseline total score of 18 on the 17-item Hamilton Depression Rating Scale (HAMD). After a 1-week placebo washout, patients were randomly allocated to the three treatment groups. Assessment of efficacy, as judged by the number of responders achieving a 50% reduction in HAMD score by the end of treatment, showed that both moclobemide and amitriptyline were significantly superior to placebo, but that they were not significantly different from each other. Both treatments differed significantly from placebo with respect to the Physician's Global Assessment of Efficacy ('very good' or 'good' response: moclobemide 57%, amitriptyline 60% and placebo 35%). Assessment of tolerance as judged by the spontaneous reporting of adverse events showed a significant superiority of moclobemide over amitriptyline, but there was no significant difference between moclobemide and placebo. At termination of the study, amitriptyline patients showed a significant elevation of heart rate both supine (10.8 beats/min) and standing (15.5 beats/min), as well as significant weight gain (1.7 kg), but no changes were seen in the moclobemide or placebo groups. In conclusion, both moclobemide and amitriptyline were found to be more effective than placebo in the treatment of depression, while moclobemide had fewer side effects.

Adult↗
PubMed1994

Comparison of cyclosporin A and azathioprine in the treatment of rheumatoid arthritis--results of a double-blind multicentre study.

In a prospective randomized double-blind multicentre study cyclosporin A (CyA) and azathioprine (AZA) were compared in 117 patients with rheumatoid arthritis (starting dose CyA 5 mg/kg, AZA 1.5-2 mg/kg). The six-month treatment period was similarly completed in 92 patients with good clinical results in both groups (mean improvement rate CyA vs. AZA: Ritchie-Index 8.2 vs. 7.7, morning stiffness 41.6 vs. 28.4 min., grip strength 10.9 vs. 15.2 mmHg, swollen joint count 28.9 vs. 27.9%). Treatment was discontinued prematurely in 12 patients in each group (CyA: 2 deaths not related to drug, 1 lack of effect, 9 adverse reactions--AZA: 2 drop-outs, 1 lack of effect, 9 adverse reactions). Altogether effectivity and tolerability were equal in both treatment groups with the exception of an increase in blood pressure and serum creatinine which occurred only in the CyA group.

Arthritis, Rheumatoid↗