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H A Gallis

Publications and source records attributed to H A Gallis.

At least 19 recordsLinked to original sources
PubMed1992

Evaluation of new antifungal drugs for the treatment of systemic fungal infections. Infectious Diseases Society of America and the Food and Drug Administration.

These guidelines are applicable to all fungal pathogens that produce systemic infections in humans. Specific examples are provided whenever they might clarify special issues. Systemic fungal infections usually are divided into two broad categories: endemic systemic fungal diseases, which occur classically in healthy hosts, and opportunistic fungal diseases, which occur almost exclusively in patients with impaired host defenses. Both the increasing frequency of disseminated histoplasmosis and coccidioidomycosis in patients with AIDS and the occurrence of candidemia due to vascular-line infections have begun to blur this distinction. The fungi included in these guidelines are Histoplasma capsulatum, Coccidioides immitis, Blastomyces dermatitidis, Candida species, Cryptococcus neoformans, Aspergillus species, and Sporothrix schenckii. Diagnosis of infections caused by these fungi should be based on culture of infected body fluids or tissues whenever possible. Cryptococcal and coccidioidal meningitis are exceptions. Amphotericin B remains the standard comparative agent for most new agents. Further studies of the efficacy of new oral agents used alone or after a hospital course of amphotericin B are needed. The agents currently available are usually inadequate for eradication of fungal infections in patients with AIDS, who may need prolonged treatment. Final assessment for these patients may need to be classified as clinical cure with presumed microbiologic persistence.

Antifungal Agents↗
PubMed1992

Azithromycin--spectrum of activity, pharmacokinetics, and clinical applications.

Azithromycin is an azalide antimicrobial agent. Structurally related to the macrolide antibiotic erythromycin, its mechanism of activity (similar to erythromycin) is interference with bacterial protein synthesis by binding to the 50S component of the 70S ribosomal subunit. Although slightly less potent than erythromycin against gram-positive organisms, azithromycin demonstrates superior activity in vitro against a wide variety of gram-negative bacilli, including Haemophilus influenzae. Absorption is approximately 37% after a 500-mg oral dose. The large volume of distribution (23 L/kg) and low peak serum level (0.4 micrograms/ml) are consistent with data demonstrating extensive tissue distribution and intracellular accumulation. Metabolism is predominantly hepatic (to inactive metabolites), with biliary excretion a major pathway of elimination. Drug elimination is biphasic, with a terminal half-life of up to 5 days. Published trials have examined the efficacy and safety of azithromycin in the treatment of adults with upper and lower respiratory tract infections, skin and skin structure infections, streptococcal pharyngitis, and sexually transmitted diseases. Many used a 5-day course of 250 mg once daily, supplemented with a 250-mg dose on the first day of therapy. Selected trials in sexually transmitted diseases examined single 1-g doses. Promising results also were obtained with oral daily doses of 500 mg in patients with human immunoviral infection who also had Mycobacterium avium complex infection and in animals with toxoplasmosis. Adverse reactions are primarily gastrointestinal (nausea, diarrhea, abdominal pain), with minimal laboratory abnormalities reported. Gastrointestinal tolerance is better than that of erythromycin. Drug interactions have not been observed to date, although coadministration of azithromycin with a large meal may reduce absorption by up to 50%.

Azithromycin↗
PubMed1989

Comparison of the safety and efficacy of intravenous ciprofloxacin and intravenous ceftazidime in the treatment of selected infections.

A study was conducted to determine the comparative safety and efficacy of intravenous ciprofloxacin with that of intravenous ceftazidime in the treatment of selected infections. Male and female inpatients 18 years or older had bacterial infections of the blood, skin or skin/structure, intra-abdominal region, lower respiratory tract, or urinary tract (considered complicated) caused by organisms susceptible to both ciprofloxacin and ceftazidime. Patients were randomly assigned to receive either ciprofloxacin 200 mg intravenously every 12 hours or ceftazidime 0.5 to 2 g intravenously every eight to 12 hours. Clinical evaluations were performed daily during therapy and within five to nine days after therapy was complete. For patients with urinary tract infection, urine for culture was obtained during (Day 3 or 4) and after (five to nine days and three to five weeks) therapy. A total of 86 patients were enrolled into the study. Forty-three received ciprofloxacin and 43 received ceftazidime. There were 22 evaluable patients in the ciprofloxacin group with 24 infection sites: skin/skin structure (eight), respiratory tract (nine), blood (two), urinary tract (five). In the ceftazidime group, there were 26 evaluable patients with 29 infection sites: skin/skin structure (15), respiratory tract (nine), blood (three), and urinary tract (two). The mean duration of therapy with ciprofloxacin and ceftazidime was 7.5 days (range, four to 28 days) and 8.4 days (range, three to 25 days), respectively. Bacteriologic eradication of the causative organisms occurred at 17 infection sites (70.8 percent) in the ciprofloxacin-treated patients and 21 infection sites (72.4 percent) in the ceftazidime group. Clinically, resolution or improvement in signs/symptoms was demonstrated in 22 patients (91.7 percent) in the ciprofloxacin group and 26 patients (89.7 percent) in the ceftazidime group. Bacteriologic response (by organism) and overall response were comparable in both groups. All enrolled patients were evaluated for determination of safety. Adverse events considered possibly or probably related to the study drugs were reported in 16 of 43 patients (37.2 percent) in the ciprofloxacin group and four of 43 patients (9.3 percent) in the ceftazidime group. Ciprofloxacin and ceftazidime were equally efficacious in the treatment of selected infections, but ciprofloxacin was associated with a higher incidence of adverse reactions probably or possibly related to drug administration. Further studies with larger sample sizes in selected patient populations will be required to identify differences in efficacy among the two antibiotics.

Adult↗
PubMed1989

Bioequivalence assessment of zidovudine (Retrovir) syrup, solution, and capsule formulations in patients infected with human immunodeficiency virus.

The objectives of this open-labeled, multiple-dose, three-way-crossover trial were to evaluate the safety and tolerance of zidovudine (Retrovir) oral syrup and to assess the bioequivalence of this formulation relative to zidovudine solution and capsule formulations in human immunodeficiency virus-infected patients. Over the 7-day study, 12 adult male subjects received 12 administrations each of the capsule, solution, and syrup formulations every 4 h (six times daily) in a randomized sequence. Frequent blood samples were collected over the 4-h period after dose 12 was administered. Zidovudine concentrations in plasma were determined by a specific and sensitive radioimmunoassay. Results from statistical analyses indicated that all three formulations were bioequivalent with respect to systemic availability (area under the time-concentration curve) and that the syrup was also equivalent to the solution with respect to the maximum peak concentration in serum. The lower relative maximum peak concentration in serum (approximately 81%) and small delays in time to peak concentration (less than 30 min) of the capsule formulation as compared with the liquid formulations are thought to be due to the additional processes of disintegration and dissolution associated with capsule administration. All three preparations were well tolerated during the 7-day study.

Acquired Immunodeficiency Syndrome↗
PubMed1988

Ofloxacin: its pharmacology, pharmacokinetics, and potential for clinical application.

Ofloxacin is a 4-quinolone antibiotic with rapid bactericidal activity against a wide variety of organisms. Its proposed mechanism of activity is interference with DNA gyrase, an enzyme essential for the replication of bacterial DNA. In vitro activity of ofloxacin includes a variety of aerobic and anaerobic bacteria. Enteric gram-negative bacilli and cocci are generally sensitive to ofloxacin; nonaeruginosa strains of Pseudomonas are less so. Numerous bacterial pathogens of the gastrointestinal tract are also sensitive to the drug. Although its MIC values for gram-positive aerobic organisms are generally higher, ofloxacin's bactericidal activity against these organisms is considered by some to be adequate, and superior to that of most other fluoroquinolones. Ofloxacin is well absorbed after oral administration. Wide tissue and body fluid distribution is demonstrated. Urinary excretion is thought to be the primary route of elimination, with 80% of the dose recovered in the urine within 24 hours. The serum half-life ranges between 2.9 and 9 hours in a dose-dependent manner. Only modest accumulation is reported after multiple-dose administration. Clinical trials using daily dosages of 100-800 mg/day in single or divided doses have been reported in the treatment of a variety of conditions such as skin and soft tissue infections, tonsillitis, sexually transmitted disease, respiratory tract infections, cystitis, and complicated and uncomplicated urinary tract infections. English reports of these trials, however, are generally limited to abstract form, making evaluation of trial design difficult. Side effects most frequently encountered include gastrointestinal and central nervous system reactions.

Anti-Bacterial Agents↗
PubMed1987

Treatment of cryptococcal meningitis with combination amphotericin B and flucytosine for four as compared with six weeks.

One hundred ninety-four patients with cryptococcal meningitis were enrolled in a multicenter, prospective, randomized clinical trial to compare the efficacy and toxicity of four as compared with six weeks of combination amphotericin B and flucytosine therapy. Among 91 patients who met preestablished criteria for randomization, cure or improvement was noted in 75 percent of those treated for four weeks and in 85 percent of those treated for six weeks. The estimated relapse rate for the four-week regimen was higher--27 as compared with 16 percent--whereas the incidence of toxic effects for the two regimens was similar--44 as compared with 43 percent. Among 23 transplant recipients, 4 of 5 treated for four weeks relapsed, leading to the decision to treat the rest of the group for six weeks. Only 3 of the 18 treated for six weeks relapsed. In a third group of 80 patients, the protocol was not followed during the initial four weeks, and these patients were not randomized. Thirty-eight died or relapsed. Multifactorial analysis of pretreatment factors for all 194 patients identified three significant predictors (P less than 0.05) of a favorable response: headache as a symptom, normal mental status, and a cerebrospinal fluid white-cell count above 20 per cubic millimeter. These and other findings in this study are consistent with the view that the four-week regimen should be reserved for patients who have meningitis without neurologic complications, underlying disease, or immunosuppressive therapy; a pretreatment cerebrospinal fluid white-cell count above 20 per cubic millimeter and a serum cryptococcal antigen titer below 1:32; and at four weeks of therapy, a negative cerebrospinal fluid India ink preparation and serum and cerebrospinal fluid cryptococcal-antigen titers below 1:8. Patients who do not meet these criteria should receive at least six weeks of therapy.

Adolescent↗
PubMed1987

Staphylococcus aureus septicemia mimicking fulminant Rocky Mountain spotted fever.

Septicemia due to Staphylococcus aureus can be a difficult diagnosis to make early in its presentation. This report illustrates a case that mimicked fulminant Rocky Mountain spotted fever in a patient with no other medical problems that might predispose her to the development of staphylococcal sepsis. Epidemiology, cerebrospinal fluid characteristics, and early biopsy of skin lesions are emphasized as important factors leading to early diagnosis and definitive treatment.

Adult↗
PubMed1987

Infections in elderly cancer patients.

In order to approach infections in elderly patients with cancer, one must have an understanding of infections in normal elderly populations. This article approaches infections in elderly patients by an examination of host factors, presentation of various organisms, infections of various body sites, diagnosis, treatment, and prevention.

Aged↗
PubMed1985

Phycomycosis of the vulva.

A necrotic ulcerative lesion of the vulva in a patient with diabetic ketoacidosis initially resembled necrotizing fasciitis. Debridement and histologic examination led to a diagnosis of phycomycosis. The condition responded to surgical debridement without antifungal therapy.

Adult↗
PubMed1985

Neurologic complications of Rocky Mountain spotted fever.

Rocky Mountain spotted fever, a serious systemic infectious illness, is common in the southeastern United States. Approximately one fourth of the cases in the United States occur in North Carolina. Widespread organ involvement occurs, with central nervous system involvement being common and occasionally severe. Since the onset of treatment with drugs such as tetracycline or chloramphenicol, the mortality has been 4%. Residual deficits are rare, but the disease retains potentially serious neurologic manifestations that must be considered and aggressively treated. A high index of suspicion should be maintained during the tick season in endemic areas. The simultaneous occurrence of illnesses such as influenza, mycoplasmal infection, and aseptic meningitis makes diagnosis a challenge.

Adolescent↗
PubMed1984

Single and multiple pyogenic liver abscesses. Natural history, diagnosis and treatment, with emphasis on percutaneous drainage.

The presenting features, modes of treatment and clinical course were reviewed for 55 patients with pyogenic liver abscess, seen at Duke University Medical Center over a 15-year period. Thirty-three patients had a solitary abscess and 22 had multiple abscesses. Most patients were between the ages of 40 and 60 years. Males predominated, 2.4:1. Major underlying conditions included biliary tract disease, malignancy and colonic disease. Eight patients, each with a solitary abscess, had no identifiable underlying condition. Symptoms and signs were nonspecific: fever, chills, focal abdominal tenderness and hepatomegaly were common. A raised serum alkaline phosphatase level was the most consistent abnormal laboratory finding. CT with contrast enhancement, radioisotope scanning and ultrasonography all accurately defined solitary hepatic abscesses. However, CT scan was more successful than other imaging techniques in detecting multiple abscesses. In seven patients the diagnosis was made only at laparotomy. Overall, a diagnosis of liver abscess was made in 50 living patients (91%). Microorganisms were recovered from pus and/or blood cultures of 44 patients (80%). Most common were enteric gram-negative facultative rods, anaerobic gram-negative rods, and microaerophilic streptococci. Single abscesses were more likely than multiple abscesses to contain more than one organism. All patients received antibiotics; the choice of antibiotic does not appear to be critical provided the regimen has a broad spectrum including activity against anaerobes. Surgical or percutaneous drainage was successful when attempted in all patients with a single abscess, but the outcome was less favorable in those with multiple abscesses. Percutaneous drainage is currently replacing open operative drainage as the method of choice. Overall mortality in patients with single abscesses was 15% (5/33) and in those with multiple abscesses 41% (9/22).

Adolescent↗
PubMed1984

Reactivity to spherule-derived coccidioidin in the southeastern United States.

Delayed hypersensitivity skin tests with mycelium-derived (coccidioidin) or spherule-derived (spherulin) antigens (or both) can be used to identify patients who have been sensitized to the dimorphic fungus Coccidioides immitis. Prior studies suggest that coccidioidin and spherulin skin test antigens detect comparable numbers of reactors among exposed subjects. Studies in subjects residing in areas outside the United States where C. immitis is not endemic suggest that both antigens are specific for the fungus. The specificity and reactivity of coccidioidin and spherulin have not been compared in nonendemic regions of the United States in which the skin test antigens and an appropriate travel or exposure history are used to identify patients with possible C. immitis infection. A review of delayed cutaneous reactions to coccidioidin in 6,375 patients tested between 1970 and 1979 in the southeastern United States revealed 958 (15.0%) and 234 (5.7%) positive reactions (greater than or equal to 5 mm), respectively, at 24 and 48 h. Subsequent tests with spherulin in 2,775 patients tested in 1980 and 1981 revealed 866 (31.2%) and 288 (10.3%) positive reactions, respectively, at 24 and 48 h. False-positive immediate hypersensitivity reactions contributed to the large number of spherulin reactors at 24 h. Differences among the patients sampled, work exposure, and travel history were excluded as causes of this surprising and highly significant (P less than or equal to 0.0001) difference in the 48-h delayed cutaneous reaction. These observations suggest two possibilities: (i) spherulin is less specific than coccidioidin, or (ii) a surprising prevalence of C. immitis sensitization exists among patients in nonendemic regions of the United States.

Antigens, Fungal↗
PubMed1984

Pulmonary blastomycosis: radiologic manifestations.

Blastomycosis, an airborne fungal disease with the lung the portal of entry, is endemic to the central and south central areas of the United States. The disease occurs in patients who range from asymptomatic to those with symptoms of acute pneumonia. Retrospective review of 27 cases from our institution revealed four well-defined radiographic patterns including air-space disease, nodular masses, interstitial disease, and cavitation. Some patients with air-space disease have symptoms of an acute pneumonia; more commonly they have no pulmonary symptoms. Air-space disease was the most frequent radiographic pattern in chronic blastomycosis with proved nonpulmonary disease; therefore, it cannot be regarded as indicative of early or acute blastomycosis. There was no relationship between the radiographic pattern and distribution, pulmonary symptomatology, or clinical stage of the disease. Our material does not support the previously suggested association of lower lobe air-space disease with early disease and upper lobe involvement with the chronic and often disseminated form. A more precise understanding of the variety of radiographic patterns and the spectrum of clinical presentations will facilitate diagnosis of pulmonary blastomycosis.

Adolescent↗
PubMed1984

Thoracic cryptococcosis: immunologic competence and radiologic appearance.

Cryptococcosis, a potentially fatal pulmonary infection, is being recognized with increased frequency in both immunologically compromised patients and those without obvious predisposing factors. This review of 24 cases of proven pulmonary cryptococcosis includes 15 immunologically compromised patients and nine noncompromised hosts. The noncompromised hosts tended to have a radiographic pattern of a peripheral nodule or nodules. The compromised hosts demonstrated a wider variety of radiographic abnormalities including single nodules, multiple nodules that progressed to confluence and/or cavitation, segmental consolidation, bilateral bronchopneumonia, or mixed patterns. Adenopathy, cavitation, and pleural effusions were limited to the compromised hosts.

Adult↗