Safety and efficacy of daptomycin in outpatient parenteral antimicrobial therapy: a prospective and multicenter cohort study (DAPTODOM trial).
BACKGROUND
Daptomycin is an optimal choice for outpatient parenteral antibiotic therapy (OPAT) because of its safety, once-daily administration and its activity against Gram-positive bacteria. Although daptomycin is increasingly being used in OPAT, limited information about its safety in this scenario is available.


METHODS
We performed a prospective multicentre pilot study to evaluate the safety of daptomycin in outpatients with proved or suspected Gram-positive infections (DAPTODOM). The primary objective was to evaluate the safety and the secondary objective to evaluate the efficacy in OPAT. We also looked at the development of daptomycin resistance in those cases with microbiological failure.


RESULTS
We included 54 patients from 12 Spanish hospitals, 67% male with a mean age of 67.1 years. Most patients (87%) had chronic underlying diseases. The main reason for inclusion was skin and soft-tissue infections in 52%, followed by bacteremia or endocarditis in 34%. Staphylococcus aureus accounted for 44% of the isolates (24% were methicillin-resistant), coagulase-negative staphylococci 15% and enterococci 7%. Two patients (4%) had to be readmitted because of complications; only one patient had an adverse effect related to daptomycin (increase in serum creatine kinase levels), which disappeared after discontinuation (2%). At the end of follow-up, 96% of patients had good outcome and only 4% of patients did not have a clinical or microbiological cure. The use of a 2-minute bolus in 18 cases was not associated with adverse effects.


CONCLUSIONS
Daptomycin was safe and efficacious in outpatients with Gram-positive bacterial infections and can be administered in 2-minute bolus infusion.
a Hospital Clinic-IDIBAPS , Universidad de Barcelona , Barcelona , Spain.|b Department of Medicine , University of Alberta , Edmonton , Canada.
Carlos
C
Cervera
c Hospital Universitario Marqués de Valdecilla , Santander , Spain.
Pedro
P
Sanroma
d Hospital Universitario Gregorio Marañón , Madrid , Spain.
Víctor
V
González-Ramallo
a Hospital Clinic-IDIBAPS , Universidad de Barcelona , Barcelona , Spain.
Cristina
C
García de la María
a Hospital Clinic-IDIBAPS , Universidad de Barcelona , Barcelona , Spain.
Gemma
G
Sanclemente
e Hospital Universitari Germans Trias i Pujol , Badalona , Spain.
Nieves
N
Sopena
c Hospital Universitario Marqués de Valdecilla , Santander , Spain.
Marcos
M
Pajarón
d Hospital Universitario Gregorio Marañón , Madrid , Spain.
Antonio
A
Segado
f Hospital Universitario de Torrejón , Torrejón de Ardoz , Spain.
Manuel
M
Mirón
g Hospital San Pedro , Logroño , Spain.
Francisco
F
Antón
h Hospital de Cruces , Bilbao , Spain.
Andima
A
Basterretxea
i Hospital Universitario Donostia , San Sebastián , Spain.
Ana
A
Cuende
a Hospital Clinic-IDIBAPS , Universidad de Barcelona , Barcelona , Spain.
José M
JM
Miró
D061605:Administration, Intravenous / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care / Q000379:methods*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D017576:Daptomycin / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D010865:Pilot Projects; D011446:Prospective Studies; D013030:Spain; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D017576:Daptomycin
Daptomycin; Gram-positive infections; MRSA; Staphylococcus aureus; bacteremia; endocarditis; outpatient parenteral antibiotic treatment (OPAT); skin and soft tissue infections; staphylococci