The efficacy of cefditoren pivoxil in the treatment of lower respiratory tract infections, with a focus on the per-pathogen bacteriologic response in infections caused by Streptococcus pneumoniae and Haemophilus influenzae: a pooled analysis of seven clinical trials.

Abstract

BACKGROUND:

Community-acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis (AECB) are frequently caused by Streptococcus pneumoniae, Haemopbilus influenzae, and Moraxella catarrbalis; thus, these are the target pathogens for antibiotic treatment.

OBJECTIVES:

This pooled analysis was performed to evaluate the efficacy of cefditoren pivoxil (CDN) in patients with lower respiratory tract infections (CAP or AECB). A particular focus was the per-pathogen bacteriologic response rate among the most common causative pathogens, S pneumoniae, H influenzae, and M catarrbalis.

METHODS:

The final reports of all clinical trials of CDN in the treatment of community-acquired lower respiratory tract infection were reviewed. Microbiologic outcome data for CDN 200 and 400 mg and comparator treatments were pooled from 4 CAP studies (3 randomized and 1 noncomparative) and 3 AECB studies. The comparators were the standard oral treatments clarithromycin 500 mg BID, cefuroxime 250 mg BID, cefpodoxime 200 mg BID, and amoxicillin/clavulanate 500/125 mg TID or 875/125 mg BID. Microbiologic response was defined as eradication of the initial pathogen or presumed eradication (absence of sputum for culture in a patient with a clinical response).

RESULTS:

The bacteriologically evaluable population contained 654 patients in the CDN 200-mg group, 592 in the CDN 400-mg group, and 664 in the comparator group. A total of 1223 target pathogens were isolated before treatment: 406 isolates of S pneumoniae (including 56 penicillin-nonsusceptible [intermediate + resistant] strains), 595 isolates of H influenzae, and 222 isolates of M catarrbalis. The microbiologic response ranged from 84.1% to 88.8% in the CAP studies and from 75.1% to 77.1% in the AECB studies, with no differences between the CDN 200-mg, CDN 400-mg, and comparator groups. In the analysis of per-pathogen bacteriologic response, similar response rates were found for S pneumoniae (range, 88.5%-92.0%), H influenzae (range, 82.7%-86.6%), and M catarrbalis (range, 84.1%-95.2%), with no significant differences between groups. Focusing on penicillin-nonsusceptible (MIC >or=0.12 microg/mL) strains of S pneumoniae, CDN (both doses pooled) was associated with a response rate of 92.3% (36/39 isolates); all nonresponders were in the CDN 200-mg group. When only penicillin-resistant (MIC >or=2 microg/mL) strains were considered, there was only 1 nonresponder, again in the CDN 200-mg group. Thus, the overall response rate to CDN (both doses pooled) was 94.4% (17/18 isolates).

CONCLUSIONS:

In this pooled analysis, CDN was associated with high rates of per-pathogen bacteriologic response among the main causative pathogens in lower respiratory tract infection. The rates of response were approximately 85% against H influenzae and approximately 90% against S pneumoniae, including penicillin-intermediate and penicillin-resistant strains.

• Authors: Juan José Granizo, María José Giménez, José Barberán, Pilar Coronel, Mercedes Gimeno, Lorenzo Aguilar
• Journal: Clinical therapeutics (Clin Ther) Vol. 28 Issue 12 Pg. 2061-9 (Dec 2006) ISSN: 0149-2918 [Print] United States
• PMID: 17296462 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't, Review)

Chemical References

• Anti-Bacterial Agents
• Cephalosporins
• cefditoren pivoxil

Topics

• Anti-Bacterial Agents (administration & dosage, pharmacology, therapeutic use)
• Bronchitis, Chronic (drug therapy, microbiology)
• Cephalosporins (administration & dosage, pharmacology, therapeutic use)
• Clinical Trials as Topic
• Community-Acquired Infections (drug therapy, microbiology)
• Drug Administration Schedule
• Haemophilus Infections (drug therapy, microbiology)
• Haemophilus influenzae (drug effects, isolation & purification)
• Humans
• Microbial Sensitivity Tests
• Pneumococcal Infections (drug therapy, microbiology)
• Pneumonia, Bacterial (drug therapy, microbiology)
• Respiratory Tract Infections (drug therapy, microbiology)
• Streptococcus pneumoniae (drug effects, isolation & purification)
• Treatment Outcome