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PubMed2004

Azithromycin for acute lower respiratory tract infections.

BACKGROUND: The spectrum of acute lower respiratory tract infection ranges from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Annually approximately five million people die of acute respiratory tract infections. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and is noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae). OBJECTIVES: To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2003), MEDLINE (January 1966 to January Week 3, 2004), and EMBASE (January 1988 to 2003). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials, which compared azithromycin to amoxycillin or amoxycillin/clavulanic acid in patients with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied. DATA COLLECTION AND ANALYSIS: The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute lower respiratory tract infections were initially pooled in the meta-analyses. Funnel plot was used to examine publication bias. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I(2) was also used to measure inconsistency results among trials. Subgroup analysis was conducted for age, types of respiratory tract infection and types of antibiotic in control groups. Sensitivity analysis was conducted under the condition of trial size and concealment of treatment allocation. MAIN RESULTS: Fourteen trials with 2,521 enrolled patients used 2,416 patients in the analysis. A total of 1,350 patients received azithromycin and 1,066 received amoxicillin or amoxicillin-clavulanic acid. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 after therapy started between the two groups (relative risk (RR) (random effects) 0.96; 95% CI 0.58 to 1.57). Sensitivity analysis showed that a reduction of clinical failure in azithromycin-treated patients (RR 0.52; 95% CI 0.24 to 1.12) in three adequately concealed studies, compared to RR 1.14 (95% CI 0.62 to 2.08) in eleven studies with inadequate concealment. Eleven trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.98; 95% CI 0.91 to 1.07). The reduction of adverse events in azithromycin group was RR 0.75 (95% CI 0.56 to 1.00). REVIEWERS' CONCLUSIONS: There is unclear evidence that azithromycin is superior to amoxicillin or amoxicillin-clavulanic acid in treating acute LRTI. Future trials with high methodological quality are needed.

Acute Disease↗
PubMedDate not supplied

Azithromycin versus doxycycline for treatment of erythema migrans: clinical and microbiological findings.

The effectiveness of azithromycin and doxycycline in the treatment of erythema migrans was compared in a prospective randomized trial. One hundred seven adult patients with typical erythema migrans, examined in the Lyme Borreliosis Outpatients' Clinic, University Department of Infectious Diseases in Ljubljana, were included in the study. Fifty-five patients received azithromycin (500 mg twice daily for the first day, followed by 500 mg once daily for four days) and 52 patients received doxycycline (100 mg twice daily for 14 days). The mean duration of skin lesions after the beginning of treatment was 7.5 +/- 5.9 days (median value 5, range 2-28 days) in the azithromycin group and 11.4 +/- 7.8 days (median value 9, range 2 days--8 weeks) in the doxycycline group (p < 0.05). Borrelia burgdorferi was isolated from erythema migrans in 28 patients before therapy: in 13 out of 52 in the doxycycline group and in 15 out of 55 in the azithromycin group. Three months after therapy, the culture was positive in four out of 13 patients treated with doxycycline and in one of the 15 patients who received azithromycin. A biopsy was repeated in all the patients with a positive isolation from the first skin specimen. During the first 12 months' follow-up, three patients treated with doxycycline but none in the azithromycin group developed major manifestations of Lyme borreliosis, while 15 doxycycline recipients and 10 azithromycin recipients developed minor consecutive manifestations.

Adolescent↗
PubMed1991

Azithromycin concentrations in sinus fluid and mucosa after oral administration.

The concentrations of azithromycin in sinus fluid and mucosal tissue were determined in a total of 23 patients with acute or chronic sinusitis. Five patients with acute sinusitis and four with chronic sinusitis were administered a five-day course of oral azithromycin (500 mg on day 1, 250 mg on days 2-5, all as single doses), and the remaining 14 patients, all with chronic sinusitis, received single oral doses of azithromycin (500 mg). With the five-day regimen, the mean levels of azithromycin in sinus fluid were markedly higher in patients with acute sinusitis (1.34 micrograms/ml) than in patients with chronic sinusitis (0.25 micrograms/ml) 24 h after the first dose. The levels of azithromycin in the sinus fluid increased from the first to the last dose in both patient groups; the mean levels of azithromycin 24 h after the last dose were 2.33 micrograms/ml in acute sinusitis patients and 0.38 micrograms/ml in chronic sinusitis patients. In chronic sufferers, the mean levels of azithromycin in the sinus fluid following a single oral dose were 0.25, 0.41, 0.57 and 0.22 micrograms/ml at 24, 48, 72 and 96 h, respectively, after administration. In these patients the mean sinus drug concentrations were much greater in the mucosal tissue (1.23 micrograms/g) than in the sinus fluid (0.41 micrograms/ml) 48 h after administration of the single dose. There were no treatment-related changes in laboratory function tests, and side effects were described as mild to moderate (five patients complained of nausea, abdominal pain or headache).(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1991

Azithromycin levels in plasma and gastric tissue, juice and mucus.

Azithromycin is the first member of a new class called the azalides. Its distribution in gastric tissues was studied in 27 patients (mean age 66 years) with proven gastric cancer due to be resected. Five groups of patients received a single 500 mg oral dose of azithromycin 24, 48, 72, 96 or 120 h pre-operatively. Samples of blood, gastric juice, mucus and gastric tissue were taken and azithromycin assayed by high performance liquid chromatography. There was an increase in the level of azithromycin in gastric juice up to the 73-96 h period reaching a median peak of 0.20 micrograms/ml. There were higher levels of azithromycin in gastric mucus (approximately double the maximum attained in gastric juice) at each of the time periods to 120 h after the dose of azithromycin. Much higher levels were seen in the gastric tissue (median peak of 4.6 micrograms/g), which were statistically significant compared with gastric juice for the first two time periods (24-48 h, p = 0.005; 49-72 h, p = 0.012). Concentrations seen in the gastric tissue specimens were between five- and 10-fold greater than those seen in gastric mucus, and approximately 20-fold greater than the levels seen in gastric juice at each of the time periods after dosing. It is concluded that remarkably high levels of azithromycin are found in gastric tissue within 24 h of a 500 mg oral dose and that these levels persist over a five-day period. There exists a significant concentration gradient from gastric tissue to gastric juice. Such levels may be advantageous in the therapy of Helicobacter pylori infections.

Administration, Oral↗
PubMed1991

Azithromycin versus cefaclor in the treatment of acute bacterial pneumonia.

In this randomised, double-blind study carried out in 28 centres, azithromycin (500 mg single dose on day 1, followed by 250 mg once-daily on days 2-5) was compared with cefaclor (500 mg t.i.d. for 10 days) in the treatment of acute bacterial pneumonia. A total of 119 patients entered the study, and of these 71 were evaluable and included in the efficacy analysis. The overall satisfactory clinical response was 97.3% for azithromycin patients and 100% for cefaclor patients. The clinical cure rates of azithromycin and cefaclor were 46.9% and 41.0%, respectively; improvement was seen in an additional 46.9% of azithromycin-treated patients and in 59.0% of the cefaclor group. The bacteriological eradication rates were 80.4% and 92.6%, respectively. These rates of clinical and bacteriological efficacy, were not statistically different. Both antibiotics were well tolerated during the study; only two patients (one on each study drug) discontinued medication due to adverse events. The overall incidence of side effects was 18.9% (10 of 53 patients) for azithromycin- and 12.1% (eight of 66 patients) for cefaclor-treated patients. Gastrointestinal disturbances were the most commonly reported side effects (nine of 10 azithromycin-treated patients and six of eight cefaclor-treated patients). In addition, two cefaclor patients reported headache. All azithromycin side effects were mild or moderate in severity, but there were two severe occurrences in the cefaclor group (1 nausea, 1 vomiting) the later leading to discontinuation.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1991

A comparison of azithromycin and penicillin V for the treatment of streptococcal pharyngitis.

The safety and efficacy of azithromycin was compared with that of penicillin V in a multicenter study of the treatment of streptococcal pharyngitis in outpatients. Patients were randomized in a 2:1 ratio to either azithromycin 500 mg once on day 1 followed by 250 mg once daily for 4 days, or penicillin V (V-Cillin K) 250 mg every 6 hours for 10 days. Two hundred and forty-two patients from 29 centers were evaluable at the 11th day after enrollment. Five of 229 (2.2%) azithromycin-treated patients were not evaluable because their enrollment isolates of group A beta-hemolytic streptococci (GABHS) were resistant to the drug. In both treatment groups, 99% of patients were clinically cured or improved. Eradication of GABHS occurred in 91% of azithromycin-treated patients compared with 96% of penicillin-treated patients (p = 0.21). Of the patients who had a recurrence of GABHS, clinical evidence of infection occurred in 3 of 13 (23%) patients who had been treated with azithromycin and in 7 of 10 (70%) patients treated with penicillin. Adverse events, generally mild to moderate gastrointestinal complaints, were significantly more common in the azithromycin-treated patients (16.6%) than in penicillin-treated patients (1.7%) (p less than 0.001). Discontinuation because of side effects occurred with similar frequency in both groups. Azithromycin appears to be a safe and effective alternative treatment for streptococcal pharyngitis in adult outpatients.

Abdominal Pain↗
PubMed1991

Multicenter evaluation of azithromycin and cefaclor in acute lower respiratory tract infections.

This was a randomized, third-party-blinded, multicenter study that compared once-daily azithromycin (500 mg on day 1, followed by 250 mg on days 2-5) to cefaclor (500 mg three times daily for 10 days) in the treatment of patients with acute bronchitis or pneumonia. A total of 546 patients were entered into the study and 272 patients were evaluable for efficacy analysis. Of these, 249 (176 azithromycin, 73 cefaclor) had bronchitis and 23 (15 azithromycin, 8 cefaclor) had pneumonia. The combined clinical cure and improvement rate, as determined by the investigator, was 96% for azithromycin and 94% for cefaclor, with 88% bacteriologic eradication in both treatment groups. The elimination of Haemophilus influenzae was significantly better with azithromycin (94.5%) than with cefaclor (61.1%) (p less than 0.001; Fisher's exact two-tail test). The two antibiotics were well tolerated during this study; the incidence of side effects reported was similar for azithromycin and cefaclor. Approximately two thirds of the side effects were mild. Only minor abnormalities in the screening laboratory tests were noted. This study shows that a 5-day course of once-daily azithromycin is as effective as a 10-day three times daily course of cefaclor in the treatment of patients with acute lower respiratory tract infections.

Azithromycin↗
PubMed1993

Preclinical toxicology studies with azithromycin: genetic toxicology evaluation.

Azithromycin was subjected to a series of three in vitro and one in vivo genetic toxicology assays for the detection of drug-associated gene or chromosomal effects. In the Ames Salmonella typhimurium tester strains TA1535, TA1537, TA98 and TA100, the presence of azithromycin was not associated with any increase in the number of his- revertants. Urine from mice dosed with up to 200 mg/kg of azithromycin also had no effect on the number of revertants in these same strains suggesting the absence of mutagenic excretory products following oral exposure. When tested up to the cytotoxic level of 240 micrograms/ml, azithromycin caused no increase in the mutant frequency at the thymidine kinase locus of L5178Y/TK cells. Both the mammalian and microbial gene mutation assays included the presence of rat-liver postmitochondrial (S9) fraction for the detection of mutagenic biotransformation products. Mitogen-stimulated human lymphocytes cultured in the presence of 2.5-7.5 micrograms/ml azithromycin for 24 h or 30.0-40.0 micrograms/ml azithromycin for 3 h in the presence of rat S9 had chromosomal aberration frequencies that were no different than negative control cells even though slight to moderate mitotic suppression was associated with these concentrations. In vivo assessment of this compound was completed in male and female mice with a single oral dose of 200 mg/kg followed by sacrifice at 6, 24 or 48 h later and metaphase analysis of bone marrow for chromosomal aberrations. No statistically significant elevations of chromosomally aberrant cells were found. We conclude that azithromycin does not cause gene mutations in microbial or mammalian cells, or chromosomal aberrations in cultured human lymphocytes or in mouse bone marrow in vivo.

Animals↗
PubMed2007

Efficacy and safety of 3-day azithromycin versus 5-day moxifloxacin for the treatment of acute bacterial exacerbations of chronic bronchitis.

Antibiotic therapy is of clinical benefit in certain patients with acute exacerbations of chronic bronchitis (AECB). In this randomised, investigator-blinded, multicentre trial, azithromycin (500mg once a day (qd) for 3 days) was compared with moxifloxacin (400mg qd for 5 days) for the treatment of outpatients with AECB (forced expiratory volume in 1s (FEV(1)) >35%). Of 342 patients randomised to either treatment, 169 received azithromycin and 173 received moxifloxacin. The mean age in the azithromycin and moxifloxacin groups was 56.4 years and 55.5 years, respectively. In the intent-to-treat analysis, clinical success rates for azithromycin and moxifloxacin were comparable at Days 10-12 (90% versus 90%, respectively) and Days 22-26 (81% versus 82%, respectively). Among patients who were culture-positive at baseline for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Haemophilus parainfluenzae, clinical efficacy for azithromycin versus moxifloxacin at Days 10-12 was 93% versus 84%, respectively, and at Days 22-26 it was 89% versus 73%, respectively. The incidence of at least one treatment-related adverse event (AE) in the azithromycin and moxifloxacin groups was 18.3% and 19.1%, respectively. The most common AEs were diarrhoea, nausea, abdominal pain and vaginitis. Most treatment-related AEs were of mild or moderate severity, with no serious treatment-related AEs. One subject in the moxifloxacin group discontinued treatment owing to a treatment-related AE (precordial pain and dry throat). Compliance with both regimens was >90%. Three-day azithromycin and 5-day moxifloxacin demonstrate comparable efficacy and safety for the treatment of AECB in outpatients.

Abdominal Pain↗
PubMed2005

Clinical evaluation of piroxicam-FDDF and azithromycin in the prevention of complications associated with impacted lower third molar extraction.

Combined treatments with non-steroidal anti-inflammatory drugs and antibiotics may offer significant benefits in the prevention of pain and infections associated with oral surgery. In this study, piroxicam and azithromycin were administered to patients undergoing dental extraction to examine the efficacy of piroxicam in the prevention of post-operative pain and inflammatory complications, either in the absence or in the presence of a concomitant antibiotic treatment. Thirty patients were randomly assigned to three groups and treated for 3 days, before impacted lower third molar removal, as follows: (1) sublingual piroxicam-FDDF (fast dissolving dosage formulation) 20 mg/day; (2) oral azithromycin 500 mg/day; (3) piroxicam-FDDF 20 mg/day plus azithromycin 500 mg/day. Oral acetaminophen (500 mg tablets) was allowed as rescue analgesic medication. Pain intensity was evaluated on a 100-mm visual-analogue scale after dental extraction (day 1), and at days 2, 3, 7 after surgery. Edema and trismus were estimated at days 2 and 7. At days 1 and 2, pain intensity was significantly lower in patients treated with piroxicam-FDDF, either alone (p < 0.05) or in combination with azithromycin (p < 0.05), than in patients administered with azithromycin alone. A higher acetaminophen consumption was also recorded in the latter group (p < 0.01). Pain intensity values did not differ among treatment groups at days 3 and 7. At day 2, the facial edema was significantly less intense in patients exposed to piroxicam-FDDF alone, as compared to patients treated with azithromycin, either alone (p < 0.05) or in combination with piroxicam-FDDF (p < 0.05). No significant differences were detected when comparing groups for trismus at days 2 and 7. The present results indicate that, when given alone in the pre-operative period, piroxicam-FDDF effectively counteracts post-surgical pain and inflammatory reactions in oral tissues. Upon combined treatment with piroxicam-FDDF and azithromycin, the macrolide antibiotic may reduce the influence of piroxicam on post-operative inflammation, without affecting its beneficial effect on surgical pain.

Adolescent↗
PubMed2001

Antimalarial activity of azithromycin, artemisinin and dihydroartemisinin in fresh isolates of Plasmodium falciparum in Thailand.

Antibiotics with antimalarial activity may offer an interesting alternative for the treatment of multidrug-resistant falciparum malaria. Azithromycin, a relatively recent semisynthetic derivative of erythromycin, was tested for its in vitro activity against fresh isolates of Plasmodium falciparum. As the reportedly slow onset of action of azithromycin suggests its combination with fast-acting substances, such as artemisinin-derivatives, dihydroartemisinin (DHA) was tested parallel as a possible combination partner. The effective concentrations found for azithromycin in this study (EC(50) = 29.3 micromol/l, EC(90) = 77.1 micromol/l blood medium mixture (BMM)) are comparable to those of other antimalarials in the antibiotics class and are considerably higher than those found for mefloquine or quinine. The absence of an activity correlation between azithromycin and chloroquine, quinine and artemisinin emphasises the independence of azithromycin drug response from the sensitivity to these drugs. A weak activity correlation (rho(EC90) = 0.352; p = 0.028), which could point to a potential cross-sensitivity but is probably of little clinical importance, was found with mefloquine above the EC(50) level. Provided that further clinical trials support the combination of these drugs, DHA may offer an interesting combination partner for azithromycin owing to its rapid onset of action and the comparatively low effective concentrations (EC(50) = 1.65 nmol/l, EC(90) = 7.10 nmol/l BMM). This combination may serve as an interesting alternative for tetracycline and doxycycline, which cannot be used in pregnant women and children, and exhibit phototoxicity. Nevertheless, the relatively high cost of this combination, as well as the controversial reports of the clinical efficacy, may limit the usefulness of azithromycin in malaria therapy and require an adjustment of previously used treatment regimens.

Animals↗
PubMedDate not supplied

Three-day course of oral azithromycin vs topical oxytetracycline/polymyxin in treatment of active endemic trachoma.

PURPOSE: The aim of this study on endemic trachoma was to carry out a comparison of azithromycin (3-day course, oral dose of 10 mg/kg per day) with conventional treatment (topical oxytetracycline/polymyxin ointment; twice a day for 2 months) in a rural area near Sanliurfa, Turkey. METHODS: Ninety-six subjects with active trachoma were randomly assigned conventional or azithromycin treatment. Subjects were examined 1, 2, 3, and 6 months after the start of treatment. Clinical findings were recorded for each eye. Swabs were taken from upper eyelids 3 and 6 months after the start of treatment for direct fluorescein antibody test. RESULTS: By six-month follow-up, trachoma had resolved clinically in 43 (89.58%) of the 48 subjects who received azithromycin, compared with 33 (68. 75%) of the 48 who were treated conventionally. Microbiological success rates (direct fluorescein antibody test negativity) were 83. 33% in the azithromycin group and 62.50% in the conventional therapy group. Compliance with both treatments was good. By 6 months, 14.58% of the subjects in azithromycin group and 33.33% of the subjects in the topical treatment group were reinfected. There were significant differences in the efficacy of the treatment effects and the re-emergence of disease between the two treatment groups. Azithromycin was well-tolerated. CONCLUSIONS: These results indicate that azithromycin may be an effective alternative for patients with active trachoma. As a systemic treatment, a 3-day course oral dose has important potential for trachoma control.

Administration, Oral↗
PubMed1993

Single dose of azithromycin for the treatment of genital chlamydial infections in adolescents.

We compared a single 1 gm dose of azithromycin with the standard 7-day course of doxycycline for the treatment of uncomplicated chlamydial genital infection in sexually active adolescents. Seventy-three adolescents (65 female) with a cervical or urethral culture positive for Chlamydia trachomatis were enrolled in the study; 46 received azithromycin and 27 received doxycycline. Follow-up evaluations were done 1, 2, and 4 weeks after treatment with azithromycin or initiation of treatment with doxycycline. There were four treatment failures (8.7%) among the patients who received azithromycin and four in the doxycycline-treated group (14.8%); all were female. Six of these girls (three treated with azithromycin and three with doxycycline) gave histories of unprotected intercourse with an untreated partner and were probably reinfected. Almost half the patients were clinically symptom free. The clinical response rate for the remaining patients with symptoms was 97.4% at 4 weeks. Nineteen percent of the azithromycin-treated patients and 33.3% of those treated with doxycycline had mild to moderate drug-related side effects, which were predominantly gastrointestinal. We conclude that treatment with a single oral dose of azithromycin appears to be as safe and efficacious as a 7-day course of doxycycline for the treatment of uncomplicated genital chlamydial infection in adolescents.

Administration, Oral↗
PubMed1998

Chlamydia in pregnancy: a randomized trial of azithromycin and erythromycin.

OBJECTIVE: To determine side effect profiles and cure rates of azithromycin compared with erythromycin in the treatment of chlamydial cervicitis complicating pregnancy. METHODS: Pregnant patients with positive DNA antigen assays for Chlamydia trachomatis were randomized to either azithromycin, 1 g oral slurry in a single dose, or erythromycin, 500 mg every 6 hours for 7 days. Repeat assays were planned for 3 weeks after therapy. Side effects, compliance, and treatment efficacy were assessed. RESULTS: One hundred six women were enrolled, and eighty-five women completed the protocol. Significantly fewer gastrointestinal side effects were noted in the azithromycin group than in the erythromycin group (11.9% versus 58.1%, P < or = .01). Enhanced compliance was noted with azithromycin, because it was given in a single observed dose. Similar treatment efficacy was noted between azithromycin and erythromycin (88.1% versus 93.0%, P > .05). CONCLUSION: Compared with erythromycin, azithromycin is associated with significantly fewer gastrointestinal side effects in pregnancy. This association, along with the ease of administration and similar efficacy, suggests that azithromycin should be considered for the initial treatment of chlamydial cervicitis in pregnancy.

Adult↗
PubMed1994

Azithromycin prophylaxis against a chloroquine-resistant strain of Plasmodium falciparum.

Azithromycin has antimalarial activity and favourable pharmacokinetic properties for a prophylactic antimalarial agent. We investigated the ability of azithromycin to prevent malaria in volunteers infected with a chloroquine-resistant strain of Plasmodium falciparum. 4 volunteers received oral azithromycin 500 mg followed by 250 mg daily for 7 further days. Subjects were infected on the third day of azithromycin. 3 subjects were protected compared with none of 15 controls. The volunteer not protected by azithromycin had unquantifiable plasma levels of azithromycin, probably because of poor absorption. Azithromycin could be a promising prophylactic agent for P falciparum malaria.

Administration, Oral↗
PubMed1999

Azithromycin in control of trachoma.

BACKGROUND: Trachoma is the leading cause of preventable blindness. Programmes to prevent blindness due to trachoma are based on community-wide treatment with topical tetracycline. We assessed the potential of community-wide azithromycin treatment for trachoma control. METHODS: Pairs of villages in trachoma endemic areas of Egypt, The Gambia, and Tanzania were matched on trachoma rates in 1-10-year-old children. Villages were randomly assigned community-wide oral azithromycin treatment (three doses with intervals of 1 week) or treatment with 1% topical tetracycline (once daily for 6 weeks). Clinical examinations were done at baseline, 2-4.5 months, and 12-14 months after treatment. Chlamydia trachomatitis was identified by ligase chain reaction (LCR). Analyses were by intention to treat. Univariate comparisons and multivariate analyses were used to compare outcomes. FINDINGS: LCR positivity was correlated with clinical severity, but about 30% of Egyptian and Gambian villagers with no active disease were LCR positive. Village-wide LCR positivity ranged from 16.5% (Tanzania) to 43.6% (Egypt). Treatment compliance was over 90% except in the tetracycline treatment village in Egypt. Of the participants initially LCR positive, 866 (95%) of 924 who received at least one azithromycin dose and 482 (82%) of 587 who received 28 days or more topical tetracycline, were negative at follow-up. At 1 year, village-wide LCR positivity rates were substantially lower than at baseline with both treatments; the decreases were greater with azithromycin than with tetracycline (93% vs 77% in Egypt, 78 vs 66% in The Gambia, 64 vs 55% in Tanzania). Similarly, greater reduction in clinical activity occurred after azithromycin. In multivariate analyses, factors associated with being LCR positive at 1 year were: not receiving azithromycin; age under 10 years; and LCR positivity at baseline. INTERPRETATION: Community-wide treatment with oral azithromycin markedly reduces C. trachomatis infection and clinical trachoma in endemic areas and may be an important approach to control of trachoma.

Administration, Oral↗
PubMed2000

Comparison of azithromycin leukocyte disposition in healthy volunteers and volunteers with AIDS.

Azithromycin, has been proved to be effective in the treatment and prophylaxis of a wide variety of infections. While the penetration of azithromycin into a number of types of mammalian cells has been well characterized, the influence of HIV infection on the intracellular disposition of this agent has not been studied. We therefore studied the disposition of azithromycin in polymorphonuclear (PMN) and mononuclear (MONO) leukocytes from six healthy volunteers and six volunteers with AIDS. After oral administration of a single 1200-mg dose of azithromycin (two 600-mg tablets), blood samples were collected over 6 days and intracellular azithromycin concentrations in MONOs and PMNs were measured. Analysis of the intracellular pharmacokinetics revealed an apparent difference in the MONO and PMN profile; this profile was similar for both groups. Intracellular concentrations of azithromycin remained high throughout the study period. Furthermore, no statistically significant differences in the intracellular area under the curve (11309+/-2543 vs. 16650+/-6254 for PMN; 14180+/-3802 vs. 21211+/-10001 for MONO) were observed between the healthy and AIDS populations, respectively. Our data confirm the extensive uptake of azithromycin by white blood cells both in healthy volunteers and in AIDS patients.

AIDS-Related Opportunistic Infections↗
PubMed2001

Characteristics and mechanisms of azithromycin accumulation and efflux in human polymorphonuclear leukocytes.

Azithromycin achieves prolonged, high tissue concentrations in spite of low serum levels and obviously must be active at tissue sites of infection to be effective. These unique features prompted us to evaluate the interactions of azithromycin and human polymorphonuclear leukocytes (PMN). Uptake of radiolabeled antibiotic by PMN was determined by a velocity-gradient centrifugation technique and expressed as the ratio of cellular to extracellular drug concentration (C/E). Azithromycin was massively accumulated by human PMN (C/E=387.2 at 2 h). Uptake was not influenced by inhibitors of cellular metabolism, but phagocytosis slightly inhibited the entry of azithromycin into PMN. After removal of extracellular drug, the release (efflux) of azithromycin from PMN was extremely slow. Agents which neutralize lysosomal pH, preventing protonation and trapping of azithromycin, markedly increased antibiotic efflux. Active concentration and prolonged retention of azithromycin by phagocytic cells should allow delivery and subsequent release of accumulated drug at sites of infection.

Anti-Bacterial Agents↗