Intravenous Azithromycin Plus Ceftriaxone Followed by Oral Azithromycin for the Treatment of Inpatients With Community-Acquired Pneumonia: An Open-Label, Non-Comparative Multicenter Trial
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Previous issue date: 2008Hospital de Base of FUNFARME. São José do Rio Preto, SP, BrasilNossa Senhora das Graças Hospital. Curitiba, PR, BrasilOtávio de Freitas General Hospital. Recife, PE, BrasilCatholic University of Campinas, Campus II. Department of Infectious Diseases. Campinas, SP, BrasilIrmandade da Santa Casa de Misericórdia of Porto Alegre. Porto Alegre, RS, BrasilUniversity Hospital of Federal University of Juiz de Fora. Juiz de Fora, MG, BrasilIrmandade da Santa Casa de Misericórdia of São Paulo. São Paulo, SP, BrasilNossa Senhora da Conceição Hospital. Porto Alegre, RS, BrasilGeneral Hospital of Itapecerica da Serra. OSS Seconci. Itapecerica da Serra, SP, BrasilGeneral Hospital Roberto Santos. Salvador, BA, BrasilFederal University of São Paulo. São Paulo, SP, BrasilFederal University of Paraná. Clinical Hospital de Clinicas. Curitiba, PR, BrasilSanatorinhos Hospital. OSS. Ação Comunitária. São Paulo, SP, BrasilCommunity-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
(500mg/day) and IVC (1g/day) for 2 to 5 days, followed by AO (500mg/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