Intravenous azithromycin plus ceftriaxone followed by oral azithromycin for the treatment of inpatients with community-acquired pneumonia: an open-label, non-comparative multicenter trial

• Published in: The Brazilian journal of infectious diseases 2008-06, Vol.12 (3), p.202-209
• Main Authors: Rubio, Fernando G, Cunha, Clóvis A, Lundgren, Fernando L C, Lima, Maria P J S, Teixeira, Paulo J Z, Oliveira, Julio C A, Golin, Valdir, Mattos, Waldo L L D, Mählmann, Herbert K, Moreira, Edson D, Jardim, Jose R, Silva, Rodney L F, Silva, Patricia H B
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; anti-bacterial agents; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Azithromycin; Azithromycin - administration & dosage; Azithromycin - adverse effects; Bacterial pneumonia; Care and treatment; Causes of; Ceftriaxone; Ceftriaxone - administration & dosage; Ceftriaxone - adverse effects; Ceftriaxone sodium; Community acquired infections; Community-Acquired Infections - drug therapy; Dosage and administration; Drug therapy; Drug Therapy, Combination; Follow-Up Studies; Health aspects; Humans; INFECTIOUS DISEASES; macrolide ketolides; Middle Aged; Pneumonia; Pneumonia, Bacterial - drug therapy; Severity of Illness Index; Treatment Outcome; Young Adult
• ISSN: 1413-8670; 1678-4391; 1678-4391
• DOI: 10.1590/S1413-86702008000300008

Community-Acquired Pneumonia (CAP) is a major public health problem. In Brazil it has been estimated that 2,000,000 people are affected by CAP every year. Of those, 780,000 are admitted to hospital, and 30,000 have death as the outcome. This is an open-label, non-comparative study with the purpose of evaluating efficacy, safety, and tolerability levels of IV azithromycin (IVA) and IV ceftriaxone (IVC), followed by oral azithromycin (OA) for the treatment of inpatients with mild to severe CAP. Eighty-six patients (mean age 56.6 +/- 19.8) were administered IVA (500 mg/day) and IVC (1g/day) for 2 to 5 days, followed by AO (500 mg/day) to complete a total of 10 days. At the end of treatment (EOT) and after 30 days (End of Study--EOS) the medication was evaluated clinically, microbiologically and for tolerability levels. Out of the total 86-patient population, 62 (72.1%) completed the study. At the end of treatment, 95.2% (CI95: 88.9% - 100%) reported cure or clinical improvement; at the end of the study, that figure was 88.9% (CI95: 74.1% - 91.7%). Out of the 86 patients enrolled in the study, 15 were microbiologically evaluable for bacteriological response. Of those, 6 reported pathogen eradication at the end of therapy (40%), and 8 reported presumed eradication (53.3%). At end of study evaluation, 9 patients showed pathogen eradication (50%), and 7 showed presumed eradication (38.89%). Therefore, negative cultures were obtained from 93.3% of the patients at EOT, and from 88.9% at the end of the study. One patient (6.67% of patient population) reported presumed microbiological resistance. At study end, 2 patients (11.11%) still reported undetermined culture. Uncontrollable vomiting and worsening pneumonia condition were reported by 2.3% of patients. Discussion and Conclusion Treatment based on the administration of IV azithromycin associated to ceftriaxone and followed by oral azithromycin proved to be efficacious and well-tolerated in the treatment of Brazilian inpatients with CAP.