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Azithromycin for acute lower respiratory tract infections

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Abstract

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 methods

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. A funnel plot was used to examine publication bias. The heterogeneity of results was investigated by the forest plot and Chi‐square test. Index of I2 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).

Authors' 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.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

Azithromycin is not better than amoxycillin or amoxyclav in the treatment of acute lower respiratory tract infections

Acute lower respiratory tract infections (LRTI) are one of the most common diagnoses in ambulatory settings. In general, people with LRTI present with cough and fever, which varies from mild to severe. Antibiotic therapy is considered in patients with a suspected bacterial cause. This review examines trials that compared different types of antibiotics (azithromycin and amoxycillin or amoxyclav) in the treatment of acute LRTI. We found that azithromycin did not have a better effect than amoxycillin or amoxyclav in terms of cure, improvement or failure.