Journal of Chemotherapy
ISSN: 1120-009X (Print) 1973-9478 (Online) Journal homepage: http://www.tandfonline.com/loi/yjoc20
Clinical Comparative Study of Azithromycin versus Erythromycin in the Treatment of Acute Respiratory Tract Infections in Children R. Manfredi, C. Jannuzzi, E. Mantero, L. Longo, R. Schiavone, A. Tempesta, D. Pavesio, P. Pecco & F. Chiodo To cite this article: R. Manfredi, C. Jannuzzi, E. Mantero, L. Longo, R. Schiavone, A. Tempesta, D. Pavesio, P. Pecco & F. Chiodo (1992) Clinical Comparative Study of Azithromycin versus Erythromycin in the Treatment of Acute Respiratory Tract Infections in Children, Journal of Chemotherapy, 4:6, 364-370, DOI: 10.1080/1120009X.1992.11739193 To link to this article: http://dx.doi.org/10.1080/1120009X.1992.11739193
Published online: 15 Jul 2016.
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Citing articles: 13 View citing articles
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Date: 26 August 2017, At: 05:30
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Journal of Chemotherapy
Vol. 4 - n. 6 (364-370) - 1992
Clinical Comparative Study of Azithromycin versus Erythromycin in the Treatment of Acute Respiratory Tract Infections in Children R. E. R. D.
MANFREDI I • C. JANNUZZP MANTER0 2 - L. LONG0 3 SCHIAVONE 3 - A. TEMPEST A 3 PAVESIO 4 - P. PECCO 4 - F. CHIODO
1
Summary ------------------------------The efficacy and tolerability of azithromycin and erythromycin in the treatment of acute respiratory tract infections in children were compared in an open, multicenter, randomized
' Istituto Malattie Infettive, Universita di Bologna. ' Clinica di Malattie Infettive, Universita di Genova. ' Divisione di Pneumofisiologia, Ospedale Pediatrico "Giovanni XXII" , Bari. • Servizio di Accettazione Pediatrica, Ospedale Regina Margherita, Torino. Address for correspondence and reprint request: Prof. Francesco Chiodo, Istituto Malattie Infettive, Universita di Bologna, Via Massarenti 11, 40138 Bologna, Italy. © Edizioni Riviste Scientifiche - Firenze
trial. A total of 151 children, aged &om 2 months to 14 years, suffering from upper airways infections (60), or lower respiratory tract infections (91), were randomized to be treated either with azithromycin, 10 mg/Kg/day per os once daily for 3 or 10 mg/Kg/day 1 and 5 mg/Kg/days 2-5 (77 patients) or with erythromycin, 50 mg/Kg/day thrice daily for at least 7 days (74 patients). The two treatment groups did not significantly differ as to sex, age, weight, type and severity of infection, and infecting pathogens. Clinical evaluation was performed prior to therapy, on treatment days 1, 3, 5 and 7, and on day 10. Microbiological and laboratory assessment were carried out at baseline and after the end of therapeutic course. Chest X-ray and serologic assays for Mycoplasma pneumoniae infection were obtained in patients suspected to have lower respiratory tract infections. At the end of therapy, clinical cure was achieved in 7 3 out of 77 patients (94.8%) in the azithromycin group, and in 60/72 evaluable subjects (83.3%) in the erythromycin group. A significantly more rapid remission of several illness-related signs and symptoms was observed in patients treated with azithromycin. A total of 75 bacterial pathogens were isolated at baseline microbiological examination; at the end of the therapeutic course bacteriological eradication was obtained in 34/34 cases (100%) treated with azithromycin, and in 40/41 children (97 .5%) treated with erythromycin. Both study drugs were well tolerated; transient, mild to moderate sideeffects were reported in 6.5% of patients treated with azith· romycin, and in 9.5% of subjects who received erythromycin. Only 2 children of the erythromycin group withdrew from the study due to adverse effects (vomiting). Significantly abnormal laboratory test values were observed in only one child treated with azithromycin (transient rise in serum AST-ALT values), and returned to normality at follow -up. In conclusion, azithromycin once daily for 3-5 days is as safe and effective as erythromycin thrice daily for at least 7 days in the treatment of community-acquired respiratory tract infections in infants and children; no statistically significant difference was found between the two treatment groups as to overall clinical and bacteriological efficacy, and systemic tolerability. The significant advantage of a low-dose therapeutic course of azithromycin is made possible by the enhanced antimicrobial potency and the favorable pharmacokinetic pro· perties of this novel macrolide derivative. Key words: azithromycin, erythromycin, respiratory tract infections, pediatric age.
ISSN 1120-009X
CLINICAL COMPARATIVE STUDY OF AZITHROMYCIN VERSUS ERYTHROMYCIN, ETC.
Downloaded by [Australian Catholic University] at 05:30 26 August 2017
INTRODUCTION
Azithromycin is a novel 15-membered-ring macrolide antibiotic of the subclass termed azalides. It differs structurally from erythromycin in that it contains a methyl-substituted nitrogen at position 9a in the lactone ring 1 • This molecular rearrangement has resulted in a compound with remarkable pharmacokinetic properties, characterized by increased acid stability and excellent oral bioavailability (approximately 40%), rapid distribution from serum to tissues, with high and sustained tissue concentrations, a prolonged post-antibiotic effect, and a terminal half- life in excess of 40 hours (following a single standard oral dose), that make once daily administration possible 2 -s. Azithromycin is rapidly distributed from the extravascular compartment to tissues where it is found at concentrations up to 100-fold greater than those in serum, and is actively concentrated in phagocytic cells (macrophages and polymorphonuclear leukocytes), which may serve as a delivery vehicle of the antimicrobial compound to the site of infection 6 - 10 • Azithromycin retains the in vitro activity of erythromycin against gram- positive organisms, but it demonstrates an expanded spectrum of activity against important gram-negative pathogens (notably Haemophilus influenzae and certain members of the Enterobacteriaceae family). Moreover, azithromycin possesses a significant activity against a wide range of intracellular pathogens, including Legionella, Mycoplasma, Chlamydia and Campylobacter spp., Staphylococcus aureus, Salmonella typhi and Toxoplasma gondii 1,11-17. Several clinical studies have provided evidence of the effectiveness and tolerability of azithromycin in adult patients in a number of clinical settings, including upper and lower respiratory tract infections, sexually- transmitted diseases, skin and soft tissue infections and gastrointestinal infections, produced by susceptible pathogens 18 - 29 • Erythromycin, the first macrolide antibiotic, maintains up to now, 40 years after its introduction in clinical practice, a potent antibacterial activity and a relevant therapeutic role in treating a wide spectrum of infectious diseases in children and adults 30 • 31 • The aim of this study is to evaluate the
365
efficacy and tolerability of azithromycin versus erythromycin in the treatment of acute nonnosocomial infections of the upper and lower respiratory tract in children.
PATIENTS AND METHODS
An open, multicenter randomized clinical trial comparing the efficacy and safety of azithromycin and erythromycin in children with respiratory tract infections was performed. Patients of both sexes with a clear diagnosis of acute community-acquired bacterial infection of the upper and lower respiratory tract, established on clinical, laboratory and radiological grounds, were considered eligible for treatment with either azithromycin oral suspension (Pfizer), at a dose of 10 mg/Kg/day once daily for 3 days or 10 mg/Kg/day and 5 mg/Kg/day 25, or erythromycin oral suspension (50 mg/Kg/day three times a day for at least 7 days). Both study drugs were administered at least one hour before or 2 hours after meals. The study excluded patients whose disease state could preclude a correct evaluation of therapeutic response. Other exclusion criteria were: known hypersensitivity or intolerance to macrolide antibiotics, severe renal or hepatic impairment, or a previous antibiotic therapy in the 72 hours preceding enrollment into the study. The trial was conducted in compliance with institutional review boards; informed consent was obtained from parents or legal guardians of patients before entering the study. Patient response to treatment was monitored by assessing clinical signs and symptoms characteristic of the infection (i.e. pharyngodynia, pharyngeal hyperemia, tonsillar exudate, otalgia, otorrhea for upper respiratory tract infections; cough, dyspnea, cyanosis, thoracic pain for lower airways infections), as well as general signs and vital parameters (body temperature, heart and respiratory rate, blood pressure), at baseline and study days 1, 3, 5, and 7, and on day 15. The severity of aforesaid signs and symptoms was assessed by means of a semiquantitative scale as follows: 0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom . Material for microbiological examination was obtained prior to treatment, in order to
Downloaded by [Australian Catholic University] at 05:30 26 August 2017
366
R. MANFREDI - C. JANNUZZI - E. MANTERO - L. LONGO,
determine the causative pathogens and their sens1t1v1ty to the study drugs. Susceptibility was evaluated using a disk- diffusion technique (Kirby-Bauer), with sensitivity to azithromycin defined by zone-inhibition diameters ~ 18 mm ·(susceptibility to erythromycin was evaluated by standard interpretative criteria). When possible, microbiological evaluation was repeated on days 7 and 15; bacteriological eradication was defined as elimination of the initial causative pathogen. Serological tests for Mycoplasma pneumoniae infection (ELISA or IIF assays) were performed upon admission in all patients suspected of having a lower airways infection. Radiological assessment was obtained before and after treatment in patients suffering from sinusitis or lower respiratory tract infection. Laboratory tests for the evaluation of efficacy and safety (complete blood count with differential, ESR, C-reactive protein, ALT, AST, alkaline phosphatase, gamma-GT, serum bilirubin, BUN, serum creatinine, LDH, blood glucose, total protein, serum electrolytes, prothrombin time, aPTT, and complete urinalysis), were performed before beginning and 48 hours after completion of therapeutic course. After the end of treatment, the investigators graded the clinical efficacy of the study drugs as follows: "cure" (disappearance of all pretreatment signs and symptoms of infection), "improvement" (improvement or partial resolution of pretreatment signs and symptoms), "failure" (no apparent clinical response to therapy). Statistical analysis was conducted using a ttest for comparing baseline characteristics of the two treatment groups; a chi-square test with continuity correction was employed to determine whether there was statistical significance between treatments. Student t-test for paired data, Wilcoxon rank sum test and Mann-Whitney test were used to evaluate the significance of changes in vital parameters and signs/symptoms during the treatment in the two study groups. All statistical comparisons were performed as two-tailed test, with significance set at p < 0.05 . RESULTS
A total of 151 subjects (60 suffering from upper airways infections, and 91 with lower respiratory tract involvement), were rando-
et alii
mized to the two treatment groups: 77 patients· received azithromycin and 7 4 subjects were treated with erythromycin. Demographic parameters, as well as clinical diagnoses and therapeutic regimens are summarized in Table 1 and Table 2. No significant differences were seen between the two treatment groups as to age, sex and weight of patients, type and severity of infection, and concurrent illness. At the end of therapy, clinical cure was achieved in 73 out of 77 patients (94.8%) in the azithromycin group, and in 60/ 72 evaluable subjects (83.3%) in the erythromycin group; moreover, a significant improvement of clinical picture was obtained in 4/ 77 children (5.2%) treated with azithromycin, and in 10/ 72 subjects (13 .9%) treated with erythromycin (Table 3). Although azithromycin treatment obtained clinical cure in a higher percentage of patients, no statistically significant difference was found between the two therapy groups regarding clinical efficacy, either considering the overall data (chi-square=5.48, p=0.0644), or by analyzing TABLE 1 - Characteristics and treatment of patients with upper respiratory tract infections.
Azithromycin Erythromycin
Patients treated Male Female Total
12 14 26
19 15 34
4.1±2.9 0.2-11
4.0±2.7 0.3-8
18.2 ±8.1 5-48
17.3±6.9 6-31
16 12 5 7 5
25 11 5 3 4
6
5
5-10
50
3.4±0.9 3-5
7.2::1::1.9 2-10
Patient age (years) Mean±SD Range
Patient weight (Kg) Mean±SD Range
Diagnosis * Tonsillitis/Adenoiditis Pharyngitis Sinusitis Otitis/Mastoiditis Laryngitis/Tracheitis
Concurrent illness Treatment **Dosing (mg/Kgfday) Duration (days) Mean±SD Range
* More than one diagnosis was possible in each patient. ** 10 mg/Kg/day once daily for 3 days or 10 mg/Kgfday 1 and 5 mg/Kg/days 2-5 .
Downloaded by [Australian Catholic University] at 05:30 26 August 2017
CLINICAL COMPARATIVE STUDY OF AZITHROMYCIN VERSUS ERYTHROMYCIN, ETC.
treatment response according to clinical diagnosis. The therapeutic course was prematurely interrupted in 4 patients who received erythromycin (in two subjects due to gastrointestinal sideeffects, and in two because of clinical failure). Both antibiotic regimens demonstrated prompt efficacy, leading to a rapid remission of pretreatment signs and symptoms; after 3 days of therapy, defervescence (body temperature :S37° C) was obtained in 43/77 patients in the azithromycin group, versus 28/72 patients in the erythromycin group (p
ISSN: 1120-009X (Print) 1973-9478 (Online) Journal homepage: http://www.tandfonline.com/loi/yjoc20
Clinical Comparative Study of Azithromycin versus Erythromycin in the Treatment of Acute Respiratory Tract Infections in Children R. Manfredi, C. Jannuzzi, E. Mantero, L. Longo, R. Schiavone, A. Tempesta, D. Pavesio, P. Pecco & F. Chiodo To cite this article: R. Manfredi, C. Jannuzzi, E. Mantero, L. Longo, R. Schiavone, A. Tempesta, D. Pavesio, P. Pecco & F. Chiodo (1992) Clinical Comparative Study of Azithromycin versus Erythromycin in the Treatment of Acute Respiratory Tract Infections in Children, Journal of Chemotherapy, 4:6, 364-370, DOI: 10.1080/1120009X.1992.11739193 To link to this article: http://dx.doi.org/10.1080/1120009X.1992.11739193
Published online: 15 Jul 2016.
Submit your article to this journal
View related articles
Citing articles: 13 View citing 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: 26 August 2017, At: 05:30
Downloaded by [Australian Catholic University] at 05:30 26 August 2017
Journal of Chemotherapy
Vol. 4 - n. 6 (364-370) - 1992
Clinical Comparative Study of Azithromycin versus Erythromycin in the Treatment of Acute Respiratory Tract Infections in Children R. E. R. D.
MANFREDI I • C. JANNUZZP MANTER0 2 - L. LONG0 3 SCHIAVONE 3 - A. TEMPEST A 3 PAVESIO 4 - P. PECCO 4 - F. CHIODO
1
Summary ------------------------------The efficacy and tolerability of azithromycin and erythromycin in the treatment of acute respiratory tract infections in children were compared in an open, multicenter, randomized
' Istituto Malattie Infettive, Universita di Bologna. ' Clinica di Malattie Infettive, Universita di Genova. ' Divisione di Pneumofisiologia, Ospedale Pediatrico "Giovanni XXII" , Bari. • Servizio di Accettazione Pediatrica, Ospedale Regina Margherita, Torino. Address for correspondence and reprint request: Prof. Francesco Chiodo, Istituto Malattie Infettive, Universita di Bologna, Via Massarenti 11, 40138 Bologna, Italy. © Edizioni Riviste Scientifiche - Firenze
trial. A total of 151 children, aged &om 2 months to 14 years, suffering from upper airways infections (60), or lower respiratory tract infections (91), were randomized to be treated either with azithromycin, 10 mg/Kg/day per os once daily for 3 or 10 mg/Kg/day 1 and 5 mg/Kg/days 2-5 (77 patients) or with erythromycin, 50 mg/Kg/day thrice daily for at least 7 days (74 patients). The two treatment groups did not significantly differ as to sex, age, weight, type and severity of infection, and infecting pathogens. Clinical evaluation was performed prior to therapy, on treatment days 1, 3, 5 and 7, and on day 10. Microbiological and laboratory assessment were carried out at baseline and after the end of therapeutic course. Chest X-ray and serologic assays for Mycoplasma pneumoniae infection were obtained in patients suspected to have lower respiratory tract infections. At the end of therapy, clinical cure was achieved in 7 3 out of 77 patients (94.8%) in the azithromycin group, and in 60/72 evaluable subjects (83.3%) in the erythromycin group. A significantly more rapid remission of several illness-related signs and symptoms was observed in patients treated with azithromycin. A total of 75 bacterial pathogens were isolated at baseline microbiological examination; at the end of the therapeutic course bacteriological eradication was obtained in 34/34 cases (100%) treated with azithromycin, and in 40/41 children (97 .5%) treated with erythromycin. Both study drugs were well tolerated; transient, mild to moderate sideeffects were reported in 6.5% of patients treated with azith· romycin, and in 9.5% of subjects who received erythromycin. Only 2 children of the erythromycin group withdrew from the study due to adverse effects (vomiting). Significantly abnormal laboratory test values were observed in only one child treated with azithromycin (transient rise in serum AST-ALT values), and returned to normality at follow -up. In conclusion, azithromycin once daily for 3-5 days is as safe and effective as erythromycin thrice daily for at least 7 days in the treatment of community-acquired respiratory tract infections in infants and children; no statistically significant difference was found between the two treatment groups as to overall clinical and bacteriological efficacy, and systemic tolerability. The significant advantage of a low-dose therapeutic course of azithromycin is made possible by the enhanced antimicrobial potency and the favorable pharmacokinetic pro· perties of this novel macrolide derivative. Key words: azithromycin, erythromycin, respiratory tract infections, pediatric age.
ISSN 1120-009X
CLINICAL COMPARATIVE STUDY OF AZITHROMYCIN VERSUS ERYTHROMYCIN, ETC.
Downloaded by [Australian Catholic University] at 05:30 26 August 2017
INTRODUCTION
Azithromycin is a novel 15-membered-ring macrolide antibiotic of the subclass termed azalides. It differs structurally from erythromycin in that it contains a methyl-substituted nitrogen at position 9a in the lactone ring 1 • This molecular rearrangement has resulted in a compound with remarkable pharmacokinetic properties, characterized by increased acid stability and excellent oral bioavailability (approximately 40%), rapid distribution from serum to tissues, with high and sustained tissue concentrations, a prolonged post-antibiotic effect, and a terminal half- life in excess of 40 hours (following a single standard oral dose), that make once daily administration possible 2 -s. Azithromycin is rapidly distributed from the extravascular compartment to tissues where it is found at concentrations up to 100-fold greater than those in serum, and is actively concentrated in phagocytic cells (macrophages and polymorphonuclear leukocytes), which may serve as a delivery vehicle of the antimicrobial compound to the site of infection 6 - 10 • Azithromycin retains the in vitro activity of erythromycin against gram- positive organisms, but it demonstrates an expanded spectrum of activity against important gram-negative pathogens (notably Haemophilus influenzae and certain members of the Enterobacteriaceae family). Moreover, azithromycin possesses a significant activity against a wide range of intracellular pathogens, including Legionella, Mycoplasma, Chlamydia and Campylobacter spp., Staphylococcus aureus, Salmonella typhi and Toxoplasma gondii 1,11-17. Several clinical studies have provided evidence of the effectiveness and tolerability of azithromycin in adult patients in a number of clinical settings, including upper and lower respiratory tract infections, sexually- transmitted diseases, skin and soft tissue infections and gastrointestinal infections, produced by susceptible pathogens 18 - 29 • Erythromycin, the first macrolide antibiotic, maintains up to now, 40 years after its introduction in clinical practice, a potent antibacterial activity and a relevant therapeutic role in treating a wide spectrum of infectious diseases in children and adults 30 • 31 • The aim of this study is to evaluate the
365
efficacy and tolerability of azithromycin versus erythromycin in the treatment of acute nonnosocomial infections of the upper and lower respiratory tract in children.
PATIENTS AND METHODS
An open, multicenter randomized clinical trial comparing the efficacy and safety of azithromycin and erythromycin in children with respiratory tract infections was performed. Patients of both sexes with a clear diagnosis of acute community-acquired bacterial infection of the upper and lower respiratory tract, established on clinical, laboratory and radiological grounds, were considered eligible for treatment with either azithromycin oral suspension (Pfizer), at a dose of 10 mg/Kg/day once daily for 3 days or 10 mg/Kg/day and 5 mg/Kg/day 25, or erythromycin oral suspension (50 mg/Kg/day three times a day for at least 7 days). Both study drugs were administered at least one hour before or 2 hours after meals. The study excluded patients whose disease state could preclude a correct evaluation of therapeutic response. Other exclusion criteria were: known hypersensitivity or intolerance to macrolide antibiotics, severe renal or hepatic impairment, or a previous antibiotic therapy in the 72 hours preceding enrollment into the study. The trial was conducted in compliance with institutional review boards; informed consent was obtained from parents or legal guardians of patients before entering the study. Patient response to treatment was monitored by assessing clinical signs and symptoms characteristic of the infection (i.e. pharyngodynia, pharyngeal hyperemia, tonsillar exudate, otalgia, otorrhea for upper respiratory tract infections; cough, dyspnea, cyanosis, thoracic pain for lower airways infections), as well as general signs and vital parameters (body temperature, heart and respiratory rate, blood pressure), at baseline and study days 1, 3, 5, and 7, and on day 15. The severity of aforesaid signs and symptoms was assessed by means of a semiquantitative scale as follows: 0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom . Material for microbiological examination was obtained prior to treatment, in order to
Downloaded by [Australian Catholic University] at 05:30 26 August 2017
366
R. MANFREDI - C. JANNUZZI - E. MANTERO - L. LONGO,
determine the causative pathogens and their sens1t1v1ty to the study drugs. Susceptibility was evaluated using a disk- diffusion technique (Kirby-Bauer), with sensitivity to azithromycin defined by zone-inhibition diameters ~ 18 mm ·(susceptibility to erythromycin was evaluated by standard interpretative criteria). When possible, microbiological evaluation was repeated on days 7 and 15; bacteriological eradication was defined as elimination of the initial causative pathogen. Serological tests for Mycoplasma pneumoniae infection (ELISA or IIF assays) were performed upon admission in all patients suspected of having a lower airways infection. Radiological assessment was obtained before and after treatment in patients suffering from sinusitis or lower respiratory tract infection. Laboratory tests for the evaluation of efficacy and safety (complete blood count with differential, ESR, C-reactive protein, ALT, AST, alkaline phosphatase, gamma-GT, serum bilirubin, BUN, serum creatinine, LDH, blood glucose, total protein, serum electrolytes, prothrombin time, aPTT, and complete urinalysis), were performed before beginning and 48 hours after completion of therapeutic course. After the end of treatment, the investigators graded the clinical efficacy of the study drugs as follows: "cure" (disappearance of all pretreatment signs and symptoms of infection), "improvement" (improvement or partial resolution of pretreatment signs and symptoms), "failure" (no apparent clinical response to therapy). Statistical analysis was conducted using a ttest for comparing baseline characteristics of the two treatment groups; a chi-square test with continuity correction was employed to determine whether there was statistical significance between treatments. Student t-test for paired data, Wilcoxon rank sum test and Mann-Whitney test were used to evaluate the significance of changes in vital parameters and signs/symptoms during the treatment in the two study groups. All statistical comparisons were performed as two-tailed test, with significance set at p < 0.05 . RESULTS
A total of 151 subjects (60 suffering from upper airways infections, and 91 with lower respiratory tract involvement), were rando-
et alii
mized to the two treatment groups: 77 patients· received azithromycin and 7 4 subjects were treated with erythromycin. Demographic parameters, as well as clinical diagnoses and therapeutic regimens are summarized in Table 1 and Table 2. No significant differences were seen between the two treatment groups as to age, sex and weight of patients, type and severity of infection, and concurrent illness. At the end of therapy, clinical cure was achieved in 73 out of 77 patients (94.8%) in the azithromycin group, and in 60/ 72 evaluable subjects (83.3%) in the erythromycin group; moreover, a significant improvement of clinical picture was obtained in 4/ 77 children (5.2%) treated with azithromycin, and in 10/ 72 subjects (13 .9%) treated with erythromycin (Table 3). Although azithromycin treatment obtained clinical cure in a higher percentage of patients, no statistically significant difference was found between the two therapy groups regarding clinical efficacy, either considering the overall data (chi-square=5.48, p=0.0644), or by analyzing TABLE 1 - Characteristics and treatment of patients with upper respiratory tract infections.
Azithromycin Erythromycin
Patients treated Male Female Total
12 14 26
19 15 34
4.1±2.9 0.2-11
4.0±2.7 0.3-8
18.2 ±8.1 5-48
17.3±6.9 6-31
16 12 5 7 5
25 11 5 3 4
6
5
5-10
50
3.4±0.9 3-5
7.2::1::1.9 2-10
Patient age (years) Mean±SD Range
Patient weight (Kg) Mean±SD Range
Diagnosis * Tonsillitis/Adenoiditis Pharyngitis Sinusitis Otitis/Mastoiditis Laryngitis/Tracheitis
Concurrent illness Treatment **Dosing (mg/Kgfday) Duration (days) Mean±SD Range
* More than one diagnosis was possible in each patient. ** 10 mg/Kg/day once daily for 3 days or 10 mg/Kgfday 1 and 5 mg/Kg/days 2-5 .
Downloaded by [Australian Catholic University] at 05:30 26 August 2017
CLINICAL COMPARATIVE STUDY OF AZITHROMYCIN VERSUS ERYTHROMYCIN, ETC.
treatment response according to clinical diagnosis. The therapeutic course was prematurely interrupted in 4 patients who received erythromycin (in two subjects due to gastrointestinal sideeffects, and in two because of clinical failure). Both antibiotic regimens demonstrated prompt efficacy, leading to a rapid remission of pretreatment signs and symptoms; after 3 days of therapy, defervescence (body temperature :S37° C) was obtained in 43/77 patients in the azithromycin group, versus 28/72 patients in the erythromycin group (p
