[Efficiency of a four-day course of pristinamycin compared to a five-day course of cefuroxime axetil for acute bacterial maxillary sinusitis in adult outpatients].

Abstract

OBJECTIVE:

The aim of this multicentric, randomized, double blind study was to demonstrate that a 4-day treatment with pristinamycin 1 g bid was as efficient as a 5-day treatment with cefuroxime axetil 250 mg bid in adults presenting with an acute maxillary sinusitis.

DESIGN:

The clinical diagnosis was based on the association of sub-orbital pain, purulent rhinorrhea and purulent discharge on the middle nasal meatus and was confirmed radiologically. A rhinoscopic bacteriologic sampling was made on the middle nasal meatus.

RESULTS:

Four hundred and eighty five patients were included in the study: in France (n = 301), Tunisia (n = 48), Poland (n = 69) and Argentina (n = 67) between January 2001 and February 2002. Cultures were positive in 199/434 patients (46%), mainly S. pneumoniae (34.2%), H. influenzae (21.5%), S. aureus (15.4%), and M. catharralis (7.9%). The clinical cure rate at day 12-19 in the per protocol population, the main study criterion, was equal to 91.4% (201/220) and 91.1% (195/214) respectively in the pristinamycin and cefuroxime axetil groups; delta = 0.14%; 95%CI: [-5.1%; 5.3%]. The non-inferiority of 4-day pristinamycin versus 5-day cefuroxime axetil was demonstrated. The efficacy at follow up after treatment (day 26-31) was 88.6% and 85.8% respectively, confirming the non-inferiority. The bacteriological cure rate at day 12-19 was 87% (87/100) and 87.9% (87/99) respectively. Both treatments were well tolerated.

CONCLUSION:

A 4-day course with pristinamycin 1 g bid is as effective as a 5-day course of cefuroxime axetil 250 mg bid in the treatment of acute maxillary sinusitis in adults.

• Authors: P Gehanno, P Berche, O Hercot, L d'Arras, S Cabrillac-Rives, E Derobert, C Choné
• Journal: Medecine et maladies infectieuses (Med Mal Infect) Vol. 34 Issue 7 Pg. 293-302 (Jul 2004) ISSN: 0399-077X [Print] France
• Vernacular Title: Efficacité comparée de la pristinamycine en quatre jours et du céfuroxime axétil en cinq jours dans le traitement des sinusites maxillaires aiguës bactériennes de l'adulte.
• PMID: 15679233 (Publication Type: Clinical Trial, Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Pristinamycin

Topics

• Acute Disease
• Adult
• Anti-Bacterial Agents (administration & dosage)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Maxillary Sinusitis (drug therapy)
• Pristinamycin (administration & dosage)
• Prospective Studies
• Time Factors