Journal of Chemotherapy
ISSN: 1120-009X (Print) 1973-9478 (Online) Journal homepage: http://www.tandfonline.com/loi/yjoc20
AIDS Patients with Bacterial Lower Respiratory Tract Infections: Treatment with Ofloxacin versus Sulbactam-Ampicillin C. De Simone, V. Trinchieri, S. Tzantzoglou, G. Famularo, S. Moretti & S. Delia To cite this article: C. De Simone, V. Trinchieri, S. Tzantzoglou, G. Famularo, S. Moretti & S. Delia (1992) AIDS Patients with Bacterial Lower Respiratory Tract Infections: Treatment with Ofloxacin versus Sulbactam-Ampicillin, Journal of Chemotherapy, 4:6, 376-380, DOI: 10.1080/1120009X.1992.11755466 To link to this article: http://dx.doi.org/10.1080/1120009X.1992.11755466
Published online: 15 Jul 2016.
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Date: 22 August 2017, At: 23:05
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Journal of Chemotherapy
AIDS Patients with Bacterial Lower Respiratory Tract Infections: Treatment with Ofloxacin versus Sulbactam · Ampicillin C. DE SIMONE - V. TRINCHIERI * S. TZANTZOGLOU * - G. FAMULARO** S. MORETTI - S. DELIA *
Summary ----------------------- -------In this open-label, randomized, parallel-groups study the Authors compare the parenteral administration of a beta· lactamase inhibitor associated with a semisynthetic penicffiin (sulbactam-ampicffiin) with the oral administration of a 3rdgeneration quinolone (ofloxacin), in 20 HIV-infected subjects suffering from lower respiratory tract (LRT) infections. 12 patients were classified as AIDS, 6 as ARC (AIDS related complex) and 2 as asymptomatic seropositive&. The risk of becoming HIV-infected and the work load for the health staff were also evaluated. The clinical and microbiological results indicate that oral ofloxacin is as effective as parenteral sulbactam-ampicffiin for the treatment of LRT infections in HIVpoaitive individuals. In addition, the ·members of the health staff reported significantly less di££iculty in administering ofloxacin in respect to sulbactam-ampicffiin. Key words: ofloxacin, quinolone, sulbactam-ampicffiin, AIDS.
Infectious Diseases, Dept. Exp. Medicine, University of L' Aquila, L' Aquila, Italy; * Infectious Diseases, University La Sapienza, Roma; ** Internal Medicine, University of L' Aquila, L' Aquila, Italy. Address correspondance to: Claudio De Simone, Infectious Diseases, Palazzo del Tosto, University of L'Aquila, L'Aquila, Italy. © Edizioni Riviste Scientifiche - Firenze
Vol. 4 - n. 6 (376-380) - 1992
INTRODUCTION
Bacterial infections of the lower respiratory tract (LRT) caused by Streptococcus pneumoniae,
Haemophilus influenzae, Klebsiella pneumoniae - are increasingly found in HIV-infected (Human Immunodeficiency Virus; HIV +)subjects, classifiable as AIDS (Acquired Immunodeficiency Syndrome) or ARC (AIDS-Related Complex) 1 • 2 • HIV + patients with pyogenic pneumonia show chest X-ray pictures similar to those of non-HIV-infected subjects and usually do not develop concomitant infections due to opportunistic microorganisms - i.e. Pneumocystis carinii. Their clinical response to proper antibacterial treatments is similar to that observed in non-immunodepressed individuals, ' and the radiologic improvement follows within 2-3 weeks 3 • Recently, it was demonstrated that the majority of bacteria isolated from AIDS patients - including Staphylococci, Escherichia coli, and Pseudomonas aeruginosa - are susceptible to fluorquinolones 4 • Because of their broad-spectrum, complete bioavailability after oral administration and high concentrations in bronchopulmonary tissue, fluorquinolones are attractive · candidates for oral treatment of LRT infections in HIV + subjects ' · 6 • In HIV + patients the oral route is preferable to the parenteral one the usual standard care - in consideration of better patient's compliance, reduced risks and work load for the health care staff. The aim of this study was to compare the parenteral administration of a beta-lactamase inhibitor associated with a semisynthetic penicillin (sulbactam-ampicillin) with the oral administration of a 3rd-generation quinolone (ofloxacin), in HIV-infected subjects suffering from lower respiratory tract infections. ISSN 1120·009X
AIDS PATIENTS WITH BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS: ETC.
PATIENTS AND METHODS
Downloaded by [Australian Catholic University] at 23:05 22 August 2017
Patients Individuals with HIV infection who were treated in the University Hospital and who could give informed consent were eligible for participation in this open-label, randomized, parallel-group study. The trial was carried out on 20 HIV + patients (16 males, 4 females) having an age ranging from 22 to 40 years (mean age 28 ± 11 years). 12 patients were classified as AIDS, 6 individuals as ARC and 2 patients as asymptomatic seropositives. Regarding risk factors, 10 subjects were drug addicts, 5 patients were homosexuals, 4 patients had been drug addicts in the past, and in only 1 case was the HIV infection transmitted through heterosexual intercourse. Criteria for entry of patients into the trial included: a) anamnestic data compatible with acute LRT infection; b) clinical symptoms of a LRT infection such as fever, cough, sputum production, dyspnea, chest pain; c) roentgenographic infiltrate compatible with LRT infection; d) cell culture of the biological material obtained from sputum and/or by broncho-alveolar lavage (BAL) demonstrating the presence of Gram-positive or Gram-negative organisms. Reasons for exclusion were previous allergic reactions to penicillin or fluoroquinolones, proven mycobacterial infections, seizure disorders, major psychiatric disorders, pregnancy, lactation, septic shock, high probability of imminent death or previous exposure to any investigational agent within 30 days. Use of antacids was strongly discouraged; zidovudine (AZT) treatment ranging from 600-1,000 mg/die was allowed.
377
days of treatment; b) a pathogen was isolated and found to be resistant to ofloxacin or sulbactam-ampicillin; c) adverse effects necessitated a change in the antimicrobial regimen.
Evaluation Before beginning the therapy, chest x-ray was performed in both anteroposterior and lateral projections on every patient, plus sputum culture examinations with identification of the causative microorganism(s) and antimicrobial susceptibility test. Antimicrobial susceptibility was determined by in vitro dilution assay with results reported as minimum inhibitory concentration (MIC 90). Using ofloxacin, MICs less than or equal to 2 J.lg/ml were susceptible, 4 J.lg/ml were intermediate, and greater than or equal to 8 J.Lg/ml were resistant. For sulbactamampicillin MICs less than or equal to 8 J.lg/ml were susceptible, 16 J.lg/ml were intermediate, and greater than or equal to 32J.Lg/ml were resis-
tant. Other investigations included complete blood counts, blood biochemistry and BAL when indicated. If pretreatment blood cultures were positive, they were repeated in the following days. In addition, before the treatment period, fresh-drawn peripheral blood leukocytes were stained with an anti-CD4 monoclonal antibody labelled with fluorescein according to the manufacturer's instructions (Becton-Dickinson, California, USA) and analyzed by flow cytometry (FACScan flow cytometer, Becton-Dickinson).
Assessment of outcome A patient was eligible for efficacy evaluation
if 5 days of therapy were given and no violaAntibiotic treatment The investigators did not know treatment assignment until after study entry. Half of the patients were assigned to ofloxacin (Sigma-tau) 600 mg (two 300-mg tablets orally every 12 hours) . For patients assigned to sulbactam-ampicillin (Loricin), therapy was administered parenterally (one ampoule with 0.5 g of sulbactam + 1 g of ampicillin every 8 hours). Patients were withdrawn from the study if: a) no response to therapy was evident after 3
tions of the protocol had taken place. As far as microbiology is concerned, the following evaluation criteria were adopted: a) success = complete eradication of the microorganism responsible for the LRT disease; b) failure = the causative microorganism persists; c) superinfection = isolation of pathogenic microorganism/s different from that isolated before beginning the treatment. Clinical response was classified as: a) cure = complete signs and symptoms resolution including radiologic amelioration; b) improvement =
Downloaded by [Australian Catholic University] at 23:05 22 August 2017
378
C. DE SIMONE - V. TRINCHIERI - S. TZANTZOGLOU - G. FAMULARO - S. MORETTI -
symptom lessening; c) failure = the signs and symptoms persist. Evaluation of possible risks and excessive load for the health care staff was assessed by using a questionnaire to be answered in written form and anonymously at the end of the therapy, in which the following items appeared: a) difficulty encountered in therapy administration; b) probability of becoming HIV-infected related to the administered antibacterial; c) work load. The scores and the relative evaluation criteria given to each parameter were as follows: 1 = nonexisting; 2 = low; 3 = moderate; 4 = high.
Statistical analysis The comparability of the treatment groups at baseline was evaluated using chi-square, twosample t-test, or Fisher's exact test. Clinical response was evaluated using the Cochran-Mantel-Haenszel procedure. RESULTS
During an 18-month period 24 HIV + patients with fever, purulent sputum and pulmonary infiltrates entered into the study and were randomized. Four patients were excluded from the study because of a history of penicillin allergy (1 individual), poor compliance (2 patients receiving sulbactam-ampicillin) and incorrect diagnosis (1 case with tuberculosis), leaving 20 evaluable patients. The patients' characteristics are reported in Table 1 and were comparable between the two groups. Ten patients were treated with ofloxacin and the remaining with sulbactam-ampicillin. Seven out of the 10 patients of the ofloxacin group (5 males, 2 females) were diagnosed as having bronchopneumonia, while 2 patients (1 male, 1 female) were diagnosed as having acute bronchitis and 1 patient (male) with relapsed chronic bronchitis. The sputum and BAL culture examination (3 cases needed the latter method) showed the presence of S. pneumoniae (2 cases), Ps. aeruginosa (2 cases), H. influenzae (2 cases), S. beta-haemolyticus (2 cases), B. catarrhalis (1 case), S. aureus (1 case). Eight subjects (80%) among those treated with ofloxacin attained complete clinical cure, while two subjects
·s.
DEUA
showed no improvement. Ofloxacin was continued for a mean of 14 ± 3 days (range 12 to 21 days). From a microbiological point of view, 8 cases attained complete eradication of the microorganisms, while in 2 cases sputum culture examination showed the persistence of previously-isolated pathogenic agents (H. influenzae and S. beta-haemolyticus). Tolerability of ofloxacin was excellent in 8 patients and good in the remaining 2 patients. None of them experienced side-effects. Regarding the group treated with sulbactamampicillin, 7 cases were diagnosed as bronchopneumonia (6 males, 1 female), 2 cases as acute bronchitis (both males) and 1 case (male) as relapsed chronic bronchitis. The sputum and BAL culture examinations (4 cases needed the latter method) showed the presence of S. pneumoniae (3 cases), H. influenzae (2 cases), B. catarrhalis (2 cases), K. pneumoniae (1 case), S. aureus (1 case), S. beta-haemolyticus (1 case) (Ta-
ble 2). Eight out of the 10 patients of the sulbactam-ampicillin group (80%) attained complete clinical cure. The mean duration of the treatment with sulbactam-ampicillin was 14 ± 3 days
TABLE 1 - Clinical feature of LR T infections treated with ofloxacin and sulbactam-ampicillin.
N. cases Males Females Mean age Age range
Ofloxacin
Sulbactamampicillin
10 7
10 9 1 30 22-40
3 26 23-28
CDC classification 6 3 1
6 3
68:1:56
71:1:39
Bronchopneumonia Acute bronchitis Chronic bronchitis
7 2 1
7 2 1
Hospital acquired Community acquired
2 8
3 7
AIDS ARC HIV+ CD4 cells/mmc
Type of infection
379
AIDS PATIENTS WITH BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS : ETC .
TABLE 2 - Isolated microorganisms and bacteriological efficacy of Ofloxacin (OFX) or Sulbactam-ampicillin (SULB) in lower respiratory tract infections of HN-infected sub;ects.
Causative Organisms
Downloaded by [Australian Catholic University] at 23:05 22 August 2017
H. in/luem:ae S. fl-haemolyticus S. pneumoniae P. aeruginosa S. aureus B. catarrhalis Causative Organisms
S. pneumoniae H. influem:ae S. fl-haemolyticus S. aureus B. catarrhalis K. pneumoniae
OFX
Susceptible
Eradicated
Persisted
2 2 2 2
2 2 2 2
1 1 2 2
1 1
1
1 1 0 0 0 0
SULB
Susceptible
Eradicated
Persisted
3 2 1
3 2 1 1 2 1
2 1 1
1 1 0 0 0 0
1 2 1
1
1 1
TABLE 3 - Results of the questionnaires completed by health care staff (12 member).
OFX
SULB
Difficulty of administration Risk of becoming HIV-infected Work load
12 12
33
15
38
Total
39
112
Score
41
= 1 = nonexisting 2 = low 3 = moderate 4 = severe
(range 12 to 20 days). From a bacteriological point of view, 8 cases attained complete eradication of the microorganisms, while in the remaining 2 cases a subsequent sputum culture examination showed the persistence of previously-isolated pathogenic agents (5. pneumoniae, H. influenzae). Sulbactam-ampicillin showed a high level of tolerability, being excellent in 7 cases and good in the remaining 3 cases. No patient developed side effects. The assessment of questionnaires for the health care staff gave 12 points to ofloxacin (=nonexisting) and 33 points (=low-moderate) to sulbactam-ampicillin with respect to the difficult administration of the drug, 12 points (=nonexisting) to ofloxacin and 41 (= moderate)
points to sulbactam-ampicillin with respect to the risk of becoming HIV-infected, and 15 points to ofloxacin (=nonexisting - moderate) and 38 points to sulbactam-ampicillin (=lowmoderate) with respect to work load. The total was 39 points for ofloxacin (=nonexisting) and 112 points for sulbactam-ampicillin ( = moderate) (p
ISSN: 1120-009X (Print) 1973-9478 (Online) Journal homepage: http://www.tandfonline.com/loi/yjoc20
AIDS Patients with Bacterial Lower Respiratory Tract Infections: Treatment with Ofloxacin versus Sulbactam-Ampicillin C. De Simone, V. Trinchieri, S. Tzantzoglou, G. Famularo, S. Moretti & S. Delia To cite this article: C. De Simone, V. Trinchieri, S. Tzantzoglou, G. Famularo, S. Moretti & S. Delia (1992) AIDS Patients with Bacterial Lower Respiratory Tract Infections: Treatment with Ofloxacin versus Sulbactam-Ampicillin, Journal of Chemotherapy, 4:6, 376-380, DOI: 10.1080/1120009X.1992.11755466 To link to this article: http://dx.doi.org/10.1080/1120009X.1992.11755466
Published online: 15 Jul 2016.
Submit your article to this journal
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=yjoc20 Download by: [Australian Catholic University]
Date: 22 August 2017, At: 23:05
Downloaded by [Australian Catholic University] at 23:05 22 August 2017
Journal of Chemotherapy
AIDS Patients with Bacterial Lower Respiratory Tract Infections: Treatment with Ofloxacin versus Sulbactam · Ampicillin C. DE SIMONE - V. TRINCHIERI * S. TZANTZOGLOU * - G. FAMULARO** S. MORETTI - S. DELIA *
Summary ----------------------- -------In this open-label, randomized, parallel-groups study the Authors compare the parenteral administration of a beta· lactamase inhibitor associated with a semisynthetic penicffiin (sulbactam-ampicffiin) with the oral administration of a 3rdgeneration quinolone (ofloxacin), in 20 HIV-infected subjects suffering from lower respiratory tract (LRT) infections. 12 patients were classified as AIDS, 6 as ARC (AIDS related complex) and 2 as asymptomatic seropositive&. The risk of becoming HIV-infected and the work load for the health staff were also evaluated. The clinical and microbiological results indicate that oral ofloxacin is as effective as parenteral sulbactam-ampicffiin for the treatment of LRT infections in HIVpoaitive individuals. In addition, the ·members of the health staff reported significantly less di££iculty in administering ofloxacin in respect to sulbactam-ampicffiin. Key words: ofloxacin, quinolone, sulbactam-ampicffiin, AIDS.
Infectious Diseases, Dept. Exp. Medicine, University of L' Aquila, L' Aquila, Italy; * Infectious Diseases, University La Sapienza, Roma; ** Internal Medicine, University of L' Aquila, L' Aquila, Italy. Address correspondance to: Claudio De Simone, Infectious Diseases, Palazzo del Tosto, University of L'Aquila, L'Aquila, Italy. © Edizioni Riviste Scientifiche - Firenze
Vol. 4 - n. 6 (376-380) - 1992
INTRODUCTION
Bacterial infections of the lower respiratory tract (LRT) caused by Streptococcus pneumoniae,
Haemophilus influenzae, Klebsiella pneumoniae - are increasingly found in HIV-infected (Human Immunodeficiency Virus; HIV +)subjects, classifiable as AIDS (Acquired Immunodeficiency Syndrome) or ARC (AIDS-Related Complex) 1 • 2 • HIV + patients with pyogenic pneumonia show chest X-ray pictures similar to those of non-HIV-infected subjects and usually do not develop concomitant infections due to opportunistic microorganisms - i.e. Pneumocystis carinii. Their clinical response to proper antibacterial treatments is similar to that observed in non-immunodepressed individuals, ' and the radiologic improvement follows within 2-3 weeks 3 • Recently, it was demonstrated that the majority of bacteria isolated from AIDS patients - including Staphylococci, Escherichia coli, and Pseudomonas aeruginosa - are susceptible to fluorquinolones 4 • Because of their broad-spectrum, complete bioavailability after oral administration and high concentrations in bronchopulmonary tissue, fluorquinolones are attractive · candidates for oral treatment of LRT infections in HIV + subjects ' · 6 • In HIV + patients the oral route is preferable to the parenteral one the usual standard care - in consideration of better patient's compliance, reduced risks and work load for the health care staff. The aim of this study was to compare the parenteral administration of a beta-lactamase inhibitor associated with a semisynthetic penicillin (sulbactam-ampicillin) with the oral administration of a 3rd-generation quinolone (ofloxacin), in HIV-infected subjects suffering from lower respiratory tract infections. ISSN 1120·009X
AIDS PATIENTS WITH BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS: ETC.
PATIENTS AND METHODS
Downloaded by [Australian Catholic University] at 23:05 22 August 2017
Patients Individuals with HIV infection who were treated in the University Hospital and who could give informed consent were eligible for participation in this open-label, randomized, parallel-group study. The trial was carried out on 20 HIV + patients (16 males, 4 females) having an age ranging from 22 to 40 years (mean age 28 ± 11 years). 12 patients were classified as AIDS, 6 individuals as ARC and 2 patients as asymptomatic seropositives. Regarding risk factors, 10 subjects were drug addicts, 5 patients were homosexuals, 4 patients had been drug addicts in the past, and in only 1 case was the HIV infection transmitted through heterosexual intercourse. Criteria for entry of patients into the trial included: a) anamnestic data compatible with acute LRT infection; b) clinical symptoms of a LRT infection such as fever, cough, sputum production, dyspnea, chest pain; c) roentgenographic infiltrate compatible with LRT infection; d) cell culture of the biological material obtained from sputum and/or by broncho-alveolar lavage (BAL) demonstrating the presence of Gram-positive or Gram-negative organisms. Reasons for exclusion were previous allergic reactions to penicillin or fluoroquinolones, proven mycobacterial infections, seizure disorders, major psychiatric disorders, pregnancy, lactation, septic shock, high probability of imminent death or previous exposure to any investigational agent within 30 days. Use of antacids was strongly discouraged; zidovudine (AZT) treatment ranging from 600-1,000 mg/die was allowed.
377
days of treatment; b) a pathogen was isolated and found to be resistant to ofloxacin or sulbactam-ampicillin; c) adverse effects necessitated a change in the antimicrobial regimen.
Evaluation Before beginning the therapy, chest x-ray was performed in both anteroposterior and lateral projections on every patient, plus sputum culture examinations with identification of the causative microorganism(s) and antimicrobial susceptibility test. Antimicrobial susceptibility was determined by in vitro dilution assay with results reported as minimum inhibitory concentration (MIC 90). Using ofloxacin, MICs less than or equal to 2 J.lg/ml were susceptible, 4 J.lg/ml were intermediate, and greater than or equal to 8 J.Lg/ml were resistant. For sulbactamampicillin MICs less than or equal to 8 J.lg/ml were susceptible, 16 J.lg/ml were intermediate, and greater than or equal to 32J.Lg/ml were resis-
tant. Other investigations included complete blood counts, blood biochemistry and BAL when indicated. If pretreatment blood cultures were positive, they were repeated in the following days. In addition, before the treatment period, fresh-drawn peripheral blood leukocytes were stained with an anti-CD4 monoclonal antibody labelled with fluorescein according to the manufacturer's instructions (Becton-Dickinson, California, USA) and analyzed by flow cytometry (FACScan flow cytometer, Becton-Dickinson).
Assessment of outcome A patient was eligible for efficacy evaluation
if 5 days of therapy were given and no violaAntibiotic treatment The investigators did not know treatment assignment until after study entry. Half of the patients were assigned to ofloxacin (Sigma-tau) 600 mg (two 300-mg tablets orally every 12 hours) . For patients assigned to sulbactam-ampicillin (Loricin), therapy was administered parenterally (one ampoule with 0.5 g of sulbactam + 1 g of ampicillin every 8 hours). Patients were withdrawn from the study if: a) no response to therapy was evident after 3
tions of the protocol had taken place. As far as microbiology is concerned, the following evaluation criteria were adopted: a) success = complete eradication of the microorganism responsible for the LRT disease; b) failure = the causative microorganism persists; c) superinfection = isolation of pathogenic microorganism/s different from that isolated before beginning the treatment. Clinical response was classified as: a) cure = complete signs and symptoms resolution including radiologic amelioration; b) improvement =
Downloaded by [Australian Catholic University] at 23:05 22 August 2017
378
C. DE SIMONE - V. TRINCHIERI - S. TZANTZOGLOU - G. FAMULARO - S. MORETTI -
symptom lessening; c) failure = the signs and symptoms persist. Evaluation of possible risks and excessive load for the health care staff was assessed by using a questionnaire to be answered in written form and anonymously at the end of the therapy, in which the following items appeared: a) difficulty encountered in therapy administration; b) probability of becoming HIV-infected related to the administered antibacterial; c) work load. The scores and the relative evaluation criteria given to each parameter were as follows: 1 = nonexisting; 2 = low; 3 = moderate; 4 = high.
Statistical analysis The comparability of the treatment groups at baseline was evaluated using chi-square, twosample t-test, or Fisher's exact test. Clinical response was evaluated using the Cochran-Mantel-Haenszel procedure. RESULTS
During an 18-month period 24 HIV + patients with fever, purulent sputum and pulmonary infiltrates entered into the study and were randomized. Four patients were excluded from the study because of a history of penicillin allergy (1 individual), poor compliance (2 patients receiving sulbactam-ampicillin) and incorrect diagnosis (1 case with tuberculosis), leaving 20 evaluable patients. The patients' characteristics are reported in Table 1 and were comparable between the two groups. Ten patients were treated with ofloxacin and the remaining with sulbactam-ampicillin. Seven out of the 10 patients of the ofloxacin group (5 males, 2 females) were diagnosed as having bronchopneumonia, while 2 patients (1 male, 1 female) were diagnosed as having acute bronchitis and 1 patient (male) with relapsed chronic bronchitis. The sputum and BAL culture examination (3 cases needed the latter method) showed the presence of S. pneumoniae (2 cases), Ps. aeruginosa (2 cases), H. influenzae (2 cases), S. beta-haemolyticus (2 cases), B. catarrhalis (1 case), S. aureus (1 case). Eight subjects (80%) among those treated with ofloxacin attained complete clinical cure, while two subjects
·s.
DEUA
showed no improvement. Ofloxacin was continued for a mean of 14 ± 3 days (range 12 to 21 days). From a microbiological point of view, 8 cases attained complete eradication of the microorganisms, while in 2 cases sputum culture examination showed the persistence of previously-isolated pathogenic agents (H. influenzae and S. beta-haemolyticus). Tolerability of ofloxacin was excellent in 8 patients and good in the remaining 2 patients. None of them experienced side-effects. Regarding the group treated with sulbactamampicillin, 7 cases were diagnosed as bronchopneumonia (6 males, 1 female), 2 cases as acute bronchitis (both males) and 1 case (male) as relapsed chronic bronchitis. The sputum and BAL culture examinations (4 cases needed the latter method) showed the presence of S. pneumoniae (3 cases), H. influenzae (2 cases), B. catarrhalis (2 cases), K. pneumoniae (1 case), S. aureus (1 case), S. beta-haemolyticus (1 case) (Ta-
ble 2). Eight out of the 10 patients of the sulbactam-ampicillin group (80%) attained complete clinical cure. The mean duration of the treatment with sulbactam-ampicillin was 14 ± 3 days
TABLE 1 - Clinical feature of LR T infections treated with ofloxacin and sulbactam-ampicillin.
N. cases Males Females Mean age Age range
Ofloxacin
Sulbactamampicillin
10 7
10 9 1 30 22-40
3 26 23-28
CDC classification 6 3 1
6 3
68:1:56
71:1:39
Bronchopneumonia Acute bronchitis Chronic bronchitis
7 2 1
7 2 1
Hospital acquired Community acquired
2 8
3 7
AIDS ARC HIV+ CD4 cells/mmc
Type of infection
379
AIDS PATIENTS WITH BACTERIAL LOWER RESPIRATORY TRACT INFECTIONS : ETC .
TABLE 2 - Isolated microorganisms and bacteriological efficacy of Ofloxacin (OFX) or Sulbactam-ampicillin (SULB) in lower respiratory tract infections of HN-infected sub;ects.
Causative Organisms
Downloaded by [Australian Catholic University] at 23:05 22 August 2017
H. in/luem:ae S. fl-haemolyticus S. pneumoniae P. aeruginosa S. aureus B. catarrhalis Causative Organisms
S. pneumoniae H. influem:ae S. fl-haemolyticus S. aureus B. catarrhalis K. pneumoniae
OFX
Susceptible
Eradicated
Persisted
2 2 2 2
2 2 2 2
1 1 2 2
1 1
1
1 1 0 0 0 0
SULB
Susceptible
Eradicated
Persisted
3 2 1
3 2 1 1 2 1
2 1 1
1 1 0 0 0 0
1 2 1
1
1 1
TABLE 3 - Results of the questionnaires completed by health care staff (12 member).
OFX
SULB
Difficulty of administration Risk of becoming HIV-infected Work load
12 12
33
15
38
Total
39
112
Score
41
= 1 = nonexisting 2 = low 3 = moderate 4 = severe
(range 12 to 20 days). From a bacteriological point of view, 8 cases attained complete eradication of the microorganisms, while in the remaining 2 cases a subsequent sputum culture examination showed the persistence of previously-isolated pathogenic agents (5. pneumoniae, H. influenzae). Sulbactam-ampicillin showed a high level of tolerability, being excellent in 7 cases and good in the remaining 3 cases. No patient developed side effects. The assessment of questionnaires for the health care staff gave 12 points to ofloxacin (=nonexisting) and 33 points (=low-moderate) to sulbactam-ampicillin with respect to the difficult administration of the drug, 12 points (=nonexisting) to ofloxacin and 41 (= moderate)
points to sulbactam-ampicillin with respect to the risk of becoming HIV-infected, and 15 points to ofloxacin (=nonexisting - moderate) and 38 points to sulbactam-ampicillin (=lowmoderate) with respect to work load. The total was 39 points for ofloxacin (=nonexisting) and 112 points for sulbactam-ampicillin ( = moderate) (p
