Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses

Autor: Andreas Karas, Areti Georgopali, Maria J G T Vehreschild, Oliver A. Cornely, Gbenga Kazeem, Nicholas Adomakoh, Benoit Guery
Rok vydání: 2019
Předmět:
Male
0301 basic medicine
genetic structures
Aged
Aged
80 and over
Anti-Bacterial Agents/administration & dosage
Anti-Bacterial Agents/pharmacology
Clostridium Infections/drug therapy
Clostridium Infections/pathology
Clostridium difficile/classification
Clostridium difficile/drug effects
Clostridium difficile/genetics
Feces/microbiology
Female
Fidaxomicin/administration & dosage
Fidaxomicin/pharmacology
Follow-Up Studies
Humans
Middle Aged
Recurrence
Ribotyping
Treatment Outcome
Vancomycin/administration & dosage
Vancomycin/pharmacology
Antibacterial agents
Clostridium difficile infection
Cohort analyses
Randomised controlled trial
law.invention
Feces
0302 clinical medicine
Randomized controlled trial
law
Clinical endpoint
Medicine
Fidaxomicin
030212 general & internal medicine
education.field_of_study
General Medicine
Clostridium difficile
Anti-Bacterial Agents
Infectious Diseases
Vancomycin
Original Article
medicine.drug
Microbiology (medical)
medicine.medical_specialty
030106 microbiology
Population
03 medical and health sciences
Internal medicine
education
Clostridioides difficile
business.industry
Cancer
medicine.disease
Regimen
Clostridium Infections
business
Zdroj: European journal of clinical microbiology & infectious diseases, vol. 38, no. 6, pp. 1187-1194
European Journal of Clinical Microbiology & Infectious Diseases
ISSN: 1435-4373
0934-9723
Popis: Poor outcomes following Clostridium difficile infection (CDI) have been associated with advanced age, presence of cancer and C. difficile PCR-ribotype 027. The impact of baseline risk factors on clinical outcomes was evaluated using data from the EXTEND study, in which rate of sustained clinical cure (SCC) in the overall population was significantly higher with an extended-pulsed fidaxomicin (EPFX) regimen than with vancomycin. Patients aged ≥ 60 years received EPFX (fidaxomicin 200 mg twice daily, days 1–5; once daily on alternate days, days 7–25) or vancomycin (125 mg four times daily, days 1–10). We analysed outcomes by advanced age, cancer diagnosis, CDI severity, prior CDI occurrence and infection with PCR-ribotype 027. The primary endpoint was SCC 30 days after end of treatment (EOT; clinical response at test-of-cure with no subsequent recurrence). SCC rates 30 days after EOT did not differ significantly between EPFX (124/177, 70.1%) and vancomycin (106/179, 59.2%) regardless of age, cancer diagnosis, CDI severity and prior CDI. In patients with PCR-ribotype 027, SCC rate 30 days after EOT was significantly higher with EPFX (20/25, 80%) than with vancomycin (9/22, 40.9%) (treatment difference, 39.1%; 95% CI, 13.2–64.9; P = 0.006). Subgroup analyses from the EXTEND study suggest that EPFX is efficacious as a potential treatment for CDI regardless of age, cancer diagnosis, infection with PCR-ribotype 027, CDI severity or prior CDI. ClinicalTrials.gov identifier: NCT02254967. Electronic supplementary material The online version of this article (10.1007/s10096-019-03525-y) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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