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These guidelines deal with the evaluation of anti-infective drugs for the treatment of respiratory tract infections. Five clinical entities are described: streptococcal pharyngitis and tonsillitis, otitis media, sinusitis, bronchitis, and pneumonia. A wide variety of microorganisms are potentially pathogenetic in these diseases; these guidelines focus on the bacterial infections. Inclusion of a patient in a trial of a new drug is based on the clinical entity, with the requirement that a reasonable attempt will be made to establish a specific microbial etiology. Microbiologic evaluation of efficacy requires isolation of the pathogen and testing for in vitro susceptibility. Alternatively, surrogate markers may be used to identify the etiologic agent. The efficacy of new drugs is evaluated with reference to anticipated response rates. Establishment of the microbial etiology of respiratory tract infections is hampered by the presence of "normal flora" of the nose, mouth, and pharynx, which may include asymptomatic carriage of potential pathogens. This issue is addressed for each category of infection described. For example, it is suggested that for initial phase 2 trials of acute otitis media and acute sinusitis tympanocentesis or direct sinus puncture be used to collect exudate for culture. Acute exacerbations of chronic bronchitis also present difficulties in the establishment of microbial etiology. These guidelines suggest that clinical trials employ an active control drug but leave open the possibility of a placebo-controlled trial. For pneumonia, the guidelines suggest the identification and enrollment of patients by the clinical type of pneumonia, e.g., atypical pneumonia or acute bacterial pneumonia, rather than by etiologic organism or according to whether it was community or hospital acquired. For each respiratory infection, the clinical response is judged as cure, failure, or indeterminate. Clinical improvement is not acceptable unless quantitative response measures can be applied.
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PMID:Evaluation of new anti-infective drugs for the treatment of respiratory tract infections. Infectious Diseases Society of America and the Food and Drug Administration. 147 53

Respiratory tract pathogens (beta-haemolytic streptococci groups A, C and G, Haemophilus influenzae, Branhamella catarrhalis or pneumococci), were isolated from nasopharyngeal and/or throat swabs in 73/138 (53%) patients greater than 10 years of age with a clinical diagnosis of acute sinusitis, acute tonsillitis, purulent nasopharyngitis or acute bronchitis. Serological evidence of a viral infection (influenza A and B, parainfluenza 1, 2 and 3, respiratory syncytial virus, adenovirus) or Mycoplasma pneumoniae infection was found in 10% of the patients. The serum content of C-reactive protein (S-CRP) was increased (greater than 12 mg/l) in 26/33 (79%) patients with streptococci and in 22/59 (37%) patients without respiratory tract bacteria. In patients with a serological evidence of a virus tonsillitis, the S-CRP was also high (32-64 mg/l). At follow-up 10-12 days after the first visit, the clinical effect of erythromycin and penicillin V was judged to be similar (90% clinical effect). Relapse or re-infection with group A streptococci were seen in 7 patients (4 on erythromycin, 3 on penicillin). In another 6 patients (3 on erythromycin, 3 on penicillin), antibiotic treatment was switched owing to persisting symptoms, probably due to H. Influenzae infection in 3 cases. The patients' own estimates of their symptoms suggested treatment with erythromycin to have a more rapid effect than treatment with penicillin.
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PMID:Erythromycin and phenoxymethylpenicillin (penicillin V) in the treatment of respiratory tract infections as related to microbiological findings and serum C-reactive protein. 190 52

Microbiological, pharmacokinetic and clinical studies on sulbactam/cefoperazone (SBT/CPZ) were carried out in the field of pediatrics. Antimicrobial activity The MIC80 of SBT/CPZ was 6.25 micrograms/ml for clinically isolated 24 strains of S. aureus (24 beta-lactamase producing strains), 0.39 micrograms/ml for 17 strains of S. pyogenes, 3.13 micrograms/ml for 24 strains of E. coli (22 beta-lactamase producing strains), 3.13 micrograms/ml for 22 strains of K. pneumoniae (22 beta-lactamase producing strains), 1.56 micrograms/ml for 22 strains of P. mirabilis and 0.20 microgram/ml for 15 strains of H. influenzae (13 beta-lactamase producing strains). In comparison with CPZ in respect to the MIC, SBT/CPZ exhibited synergistic effect on 31 strains out of 81 beta-lactamase producing strains (included 6 strains of S. aureus, 9 of E. coli, 5 of K. pneumoniae and 11 of H. influenzae) which was scarcely observed against 43 non-beta-lactamase producing strains. Absorption and excretion Serum levels and urinary excretion of SBT/CPZ were studied in 7 children aged 5 to 12 years. The mean serum concentration of SBT at 15 minutes following a single intravenous injection of 10 mg/kg of SBT/CPZ was 14.2 micrograms/ml and that of CPZ was 30.4 micrograms/ml. The mean urinary recovery rates at 6 hours following the intravenous injection were 57.8% and 18.3%, respectively. The mean serum concentrations of SBT and CPZ after 1-hour infusion of 10 mg/kg of SBT/CPZ were 10.9 micrograms/ml and 17.6 micrograms/ml, respectively. The urinary recovery rates of SBT and CPZ at 7 hours after the infusion were 100.0% and 27.7% on average, respectively. The mean serum levels of SBT and CPZ at 15 minutes after a single intravenous injection of 20 mg/kg of SBT/CPZ were 25.6 micrograms/ml and 66.0 micrograms/ml, respectively and urinary elimination until up to 6 hours were 72.5% on average for SBT and 21.1% for CPZ. Clinical study SBT/CPZ was used for the treatment of a total of 20 pediatric patients aged 1 month to 14 years to evaluate its clinical effectiveness, bacteriological efficacy and adverse effects. The clinical efficacy in 6 patients with acute pneumonia, 3 with staphylococcal scalded skin syndrome, 2 each with acute purulent tonsillitis and acute pyelonephritis, 1 each with acute purulent lymphadenitis, acute sinusitis, acute bronchitis, peritonitis and acute enteritis was judged to be excellent in 15 cases and good in 3 cases with an efficacy ratio of 100%. The clinical efficacy in 6 patients whose infections were caused by beta-lactamase producing strains was judged to be excellent in all the cases.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:[Studies on sulbactam/cefoperazone in the field of pediatrics]. 609 65

T-1982 (cefbuperazone), a new injectable cephamycin antibiotic, was studied for its antibacterial activity, concentration in serum and urine, penetration into cerebrospinal fluid (CSF) as well as clinical application. The following results were obtained. 1. Antibacterial activity: The susceptibilities of clinically isolated K. pneumoniae, E. coli and E. cloacae to T-1982 were superior to those of CEZ CMZ, and ABPC. T-1982 seemed to be useful for various infections due to Gram-negative rods. 2. Concentration in serum and urine: Subjects were 10 children with congenital heart failure but no abnormal renal and liver functions. T-1982 was given intravenously to 3 groups at 200 mg/kg by one shot (4 cases), 20 mg/kg by 1 hour drip infusion (3 cases) and 10 mg/kg by 1 hour drip infusion (3 cases). The half-lives were 60, 78 and 85 minutes, respectively. 3. Penetration into cerebrospinal fluid: Three children with malignant tumor were injected 20 mg/kg intravenously. A small amount of T-1982 was penetrated into CSF. 4. Clinical efficacy: T-1982 was administered daily 40-116 mg/kg t.i.d. or q.i.d. for 2-14 days to 17 children comprising 1 bronchopneumonia, 1 bronchitis, 4 tonsillitis, 1 lymphadenitis, 1 sepsis, 1 pharyngitis, 1 impetigo, 1 acute sinusitis and 6 pyelonephritis. Clinical efficacy was excellent in 10, good in 2, fair and poor in 3, and the efficacy rate was 70.6%. Bacteriological effect was as follows; eradicated in 9 cases and unknown in 8 cases. As side effect, GOT and GPT elevations unrelated to the drug were observed in 2 cases. Other abnormal findings were not found. T-1982 seems to be safe antibiotic in the field of pediatrics.
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PMID:[Fundamental and clinical studies on T-1982 (cefbuperazone) in the field of pediatrics]. 634 37

The chemistry, microbiology, pharmacokinetics, therapeutic use, adverse effects, and dosage of amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic combination, are reviewed. Clavulanic acid is a "suicide" inhibitor of bacterial beta-lactamase enzymes and has been effective in preventing destruction of penicillins by these enzymes. Clavulanic acid alone has weak antibacterial activity against most organisms. After oral administration, clavulanic acid is rapidly absorbed; amoxicillin appears to increase its absorption. Absorption of amoxicillin-clavulanic acid is not affected by food. Amoxicillin-clavulanic acid is effective in treating both acute uncomplicated and complicated urinary-tract infections and exacerbations of chronic bronchitis caused by amoxicillin-resistant organisms in adults. It appears to be comparable in efficacy to cefaclor for treating uncomplicated urinary-tract infections in adults and children, acute bronchitis and bronchopneumonia, and acute sinusitis, otitis media, and skin and soft-tissue infections in children. Other infections for which the combination has been effective include cellulitis and intra-abdominal and pelvic sepsis caused by mixed aerobic/anaerobic organisms. Amoxicillin-clavulanic acid has also successfully cured urethritis in men caused by penicillinase-producing Neisseria gonorrhoeae and is superior to amoxicillin alone for beta-lactamase-positive Haemophilus ducreyi infections (chancroid). Diarrhea or loose stools is the most common side effect seen with amoxicillin-clavulanic acid; nausea, vomiting, and skin rash may also occur. Nausea, vomiting, and diarrhea may be lessened by taking the combination with food.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic combination. 639 83

Antibiotics account for 15 percent to 20 percent of all new and refill prescriptions issued in ambulatory community practice. Antibiotic-prescribing practices in our emergency room for common outpatient infections-pharyngitis, bronchitis, sinusitis, otitis media, cellulitis, cutaneous abscesses and pneumonia-were evaluated. Antibiotic selection was compared with recommendations representing current standards for care, and the cost of each was approximated. Antibiotic agents were judged to be overused in patients with pharyngitis, bronchitis and cutaneous abscesses. Patients who had acute sinusitis and otitis media often did not receive antibiotics or received an antibiotic not active against Hemophilus influenzae. A simple audit of antimicrobial drug usage for common outpatient infections proved to be a cost-effective way to identify excessive or inappropriate drug use. This approach could be used for evaluating the use of other drugs, and the results of these evaluations could serve to focus continuing educational programs.
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PMID:Patterns of antibiotic use in a busy metropolitan emergency room: analysis of efficacy and cost-appropriateness. 641 May 88

The main pathogens of gram-negative infections are Neisseria gonorrhoeae, Neisseria meningitidis and Moraxella catarrhalis infection. N. Gonorrhoeae infection is one of the STD, but the chemotherapy for this infection is very easy because this pathogen is very susceptible to new quinolones. Meningococcal infection is very rare in Japan. Since 1980, M. catarrhalis is one of the important pathogen of respiratory infections such as acute bronchitis, pneumonia, chronic bronchitis. This pathogen also causes acute sinusitis and otitis. Most pathogenic strains of M. catarrhalis are beta-lactamase producing.
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PMID:[Gram-negative coccus infection]. 812 87

Although the pulmonary complications of advanced human immunodeficiency virus (HIV) infection have been well described, there is little information on respiratory manifestations of earlier disease. This report describes the respiratory disorders diagnosed over an 18-month period in a cohort of persons with or at risk for HIV infection with variable immunologic status. Cohort members were followed routinely and evaluated for respiratory disease by standard diagnostic algorithms. The 18-month incidence of each respiratory diagnosis was determined, and for frequent diagnoses, incidence by transmission category, location of residence, smoking status, CD4 count, and performance score at entry were compared. The most frequent respiratory diagnoses in HIV-seropositive cohort members were common to the general population: upper respiratory infection (33.4%), acute bronchitis (16.0%), acute sinusitis (5.3%), and bacterial pneumonia (4.8%). Pneumocystis carinii pneumonia occurred in 3.9%. Ambulatory respiratory illnesses were reported frequently regardless of immunologic status. The rates of P. carinii pneumonia and bacterial pneumonia were significantly greater in cohort members with entry CD4 counts < 250. Bacterial pneumonia occurred more frequently in injecting drug users and in cohort members with entry Karnofsky scores < 90. Disease stage and demographic and exposure factors are important variables affecting the respiratory manifestations of HIV infection.
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PMID:Respiratory illness in persons with human immunodeficiency virus infection. The Pulmonary Complications of HIV Infection Study Group. 825 94

An open non-comparative clinical study to determine the efficacy and tolerance of Roxithromycin 150 mg twice daily was carried out amongst Nigerian patients with acute upper and lower respiratory tract infections. Twenty-four (24) patients (mean age 21.6 years, male 13; females 11 who completed the study presented with acute tonsillitis (33.3%, acute bronchitis (12.5%), lober pneumonia (12.5%), Otitis media (8%), acute pharyngitis (4%) and acute sinusitis (4%). Most of the patients had normal bacterial flora isolated (50.3%). Pathogens isolated included streptococcus pyogenes (21%), moraxella catarhalis (8.3%), streptococcus pneumonia (8.3%) and Klebsiella pneumonia (4%). The quick clinical response, lack of major adverse drug reactions and susceptibility of the bacterial isolates to Roxithromycin were very significant attributes of the drug. In addition, there was complete recovery in 95.8% of the patients. Roxithromycin is therefore a well tolerated and effective drug for the treatment of acute respiratory tract infections in Nigerian patients.
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PMID:Open clinical trial of roxithromycin amongst patients of Jos University Teaching Hospital with lower and upper respiratory tract infections. 851 97

Pharmacokinetic, bacteriological and clinical studies were performed in pediatrics on tazobactam/piperacillin (TAZ/PIPC), a combined drug of a new beta-lactamase inhibitor tazobactam and piperacillin at a ratio of 1:4. 1. Serum levels and urinary excretions of TAZ, PIPC and desethyl piperacillin (DEt-PIPC), a metabolite of PIPC, after one shot intravenous administration of 50 mg/kg of TAZ/PIPC to two children (6-7 years old) were investigated. The serum TAZ level at 0.08 hour was 50.8-51.0 micrograms/ml after administration. Then TAZ concentrations gradually decreased with half-lives of 0.38-0.45 hour, and reached 1.0-1.4 micrograms/ml after 2 hours and was not detected after 3 hours and 6 hours. Serum PIPC levels at 0.08 hour was 167.0-231.0 micrograms/ml after administration. Then PIPC concentrations gradually decreased with half-lives of 0.41-0.55 hour, and reached 1.2-2.4 micrograms/ml after 3 hours and was not detected after 6 hours. DEt-PIPC was detected slightly in serum. A ratio of TAZ to PIPC was about 1 to 4 in serum at each time. Urinary recovery rates of TAZ in the first 6 hours after administration of TAZ/PIPC were 33.5-90.1% and those of PIPC were 41.9-77.8% and those of DEt-PIPC were 1.5-2.8%. 2. TAZ/PIPC was administered to 27 pediatric patients (their ages ranged between 2 months and 11 years old) with various infections, and clinical and bacteriological effects and adverse reactions were investigated. Single doses were 26.2-55.6 mg/kg, frequencies of administration were 3-4 times a day, and durations of administration were 3 1/3-7 1/3 days, and total dosages were 4.5-33.75 g. Clinical effects were evaluable in 26 cases. Responses were rated as "good" in acute purulent tonsillitis 1 case and acute purulent otitis media 1 case, as "excellent" in acute sinusitis 1 case, as "excellent" in 2 and "good" in 1 out of 3 cases of acute bronchitis, as "excellent" in 13 and "good" 2 out of 15 cases of acute pneumonia, as "excellent" in acute urinary tract infection 2 cases and as "excellent" in acute enteritis in 1 case, acute appendicitis in 1 case and lymphadentis in 1 case. In all cases, the results were rated as "good" or "excellent". Antimicrobial effects against a total of 10 strains identified or assumed to be pathogenic bacteria were evaluated. The 10 strains of bacteria included 4 strains of Streptococcus pneumoniae, 3 strains of Haemophilus influenzae (2 strains beta-lactamase producing), 2 strains of beta-lactamase producing Moraxella catarrhalis, 1 strain of beta-lactamase producing Morganella morganii. All the bacteria listed here were judged to have been eradicated. Adverse reaction was observed in 1 case with mild diarrhea. As abnormal changes in laboratory data, leucocytopenia in 1 case, elevation of GOT. GPT in 2 cases and eosinophilia in 1 case were observed. On the basis of the findings, TAZ/PIPC was considered to be effective and safe in the treatment of pediatric infections.
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PMID:[Pharmacokinetic, bacteriological and clinical evaluation of tazobactam/piperacillin in pediatrics]. 969 67


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