[Efficacy and safety of pristinamycin vs amoxicillin in community acquired pneumonia in adults].

Abstract

STUDY OBJECTIVE:

Evaluation of efficacy and safety of pristinamycin (PRI), compared with amoxicillin (AMX), both at 3 g daily for 7 to 10 days in adults with community-acquired pneumonia (CAP).

PATIENTS AND METHODS:

Multinational, randomized, double blind, double dummy clinical trial of non-inferiority was conducted in 399 patients with a CAP.

RESULTS:

At inclusion, the mean age was 47.8+/-18.3 years, 24.3% patients were 65 or older. The Fine score was < or =III in 85.4% patients. The bacterial etiology was documented in 34.8% of patients: Streptococcus pneumoniae (48.1%), Mycoplasma pneumoniae (18.6%), Haemophilus influenzae (14.7%), Chlamydia pneumoniae (13.2%), Legionella pneumophila (9.3%). In the clinical per-protocol population, the clinical success rate was 87.6% in each group: 149/170 patients (PRI) and 148/169 (AMX); The 95% confidence interval was [-6.61%; 7.23%]. In modified intend to treat population, the clinical success rate was 79.9% (151/189) in the PRI group and 83.0% (151/182) in the AMX group [CI 95% (-10.87%; 4.69%)]. A satisfactory bacteriological response was observed in 82.3% (51/62) of PRI patients and 88.1% (59/67) of AMX patients. Treatment related adverse events occurred similarly in both groups according to the expected tolerance profile of the two drugs. No serious adverse events in both groups were related to the study drugs.

CONCLUSIONS:

In this study, PRI 3 g daily was clinically as effective and well tolerated as AMX 3 g daily, for 7 to 10 days, in PPc, in the treatment of bacterial community-acquired pneumonia.

• Authors: F Trémolières, C Mayaud, Y Mouton, P Weber, F Dellatolas, E Caulin
• Journal: Pathologie-biologie (Pathol Biol (Paris)) 2005 Oct-Nov Vol. 53 Issue 8-9 Pg. 503-10 ISSN: 0369-8114 [Print] France
• Vernacular Title: Essai comparatif de l'efficacité et de la tolérance de la pristinamycine vs amoxicilline dans le traitement des pneumonies aiguës communautaires de l'adulte.
• PMID: 16181747 (Publication Type: Clinical Trial, Phase IV, Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Placebos
• Pristinamycin
• Amoxicillin

Topics

• Adult
• Aged
• Amoxicillin (therapeutic use)
• Anti-Bacterial Agents (therapeutic use)
• Community-Acquired Infections (drug therapy, microbiology)
• Double-Blind Method
• Female
• France
• Humans
• Male
• Middle Aged
• Placebos
• Pneumonia, Bacterial (drug therapy, transmission)
• Pristinamycin (therapeutic use)
• Sensitivity and Specificity
• Treatment Outcome